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Trial record 5 of 11 for:    LY2062430

Continued Safety Monitoring of Solanezumab (LY2062430) in Alzheimer's Disease (EXPEDITION EXT)

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ClinicalTrials.gov Identifier: NCT01127633
Recruitment Status : Terminated (Solanezumab did not meet the primary endpoint in study H8A-MC-LZAX.)
First Posted : May 21, 2010
Results First Posted : May 3, 2018
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Interventions Drug: Solanezumab
Drug: Placebo
Enrollment 1457
Recruitment Details Participants who completed one of the feeder studies (Study LZAM (NCT00905372) or Study LZAN (NCT00904683)) were enrolled in this study.
Pre-assignment Details  
Arm/Group Title Placebo Solanezumab
Hide Arm/Group Description Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80. 400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
Period Title: Overall Study
Started 723 734
Received at Least 1 Dose of Study Drug 723 734
Completed 70 61
Not Completed 653 673
Reason Not Completed
Adverse Event             74             73
Death             40             43
Lost to Follow-up             4             0
Parent/Caregiver Decision             246             228
Physician Decision             60             45
Withdrawal by Subject             57             72
Sponsor Decision             163             195
Protocol Violation             8             16
Abnormal Lab/ECG Result             0             1
Not treated             1             0
Arm/Group Title Placebo Solanezumab Total
Hide Arm/Group Description Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80. 400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years. Total of all reporting groups
Overall Number of Baseline Participants 723 734 1457
Hide Baseline Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 723 participants 734 participants 1457 participants
73.10  (8.004) 72.96  (7.766) 73.03  (7.883)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 723 participants 734 participants 1457 participants
Female 406 415 821
Male 317 319 636
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 723 participants 734 participants 1457 participants
American Indian or Alaska Native 0 0 0
Asian 137 149 286
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 13 16 29
White 571 566 1137
More than one race 2 3 5
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 723 participants 734 participants 1457 participants
Argentina 41 40 81
United States 264 243 507
Japan 69 87 156
United Kingdom 17 18 35
Spain 15 22 37
Russia 13 15 28
Canada 38 40 78
South Korea 33 32 65
Sweden 21 15 36
Taiwan 26 23 49
Poland 18 25 43
Brazil 38 34 72
Italy 41 45 86
Australia 30 30 60
France 22 23 45
Germany 37 42 79
1.Primary Outcome
Title Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)
Hide Description The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time Frame Baseline through Week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Placebo Solanezumab
Hide Arm/Group Description:
Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
Overall Number of Participants Analyzed 723 734
Measure Type: Number
Unit of Measure: participants
SAE 308 299
Other AE 485 514
2.Secondary Outcome
Title Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14)
Hide Description ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean was determined by mixed model repeated measures (MMRM) methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 Mini-Mental State Examination (MMSE) status (mild/moderate), concomitant acetylcholinesterase inhibitors (AChEI)/Memantine use at baseline (yes/no), baseline age and treatment*visit.
Time Frame Baseline, Week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for ADAS-Cog14.
Arm/Group Title Placebo Solanezumab
Hide Arm/Group Description:
Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
Overall Number of Participants Analyzed 409 451
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
17.58  (0.532) 17.56  (0.517)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Solanezumab
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The noninferiority margin for this hypothesis was specified as 50% of the treatment difference observed at the end of the feeder study. If the lower limit of the confidence interval (CI) was greater than 0, the noninferiority criterion was met, indicating that at least 50% of the treatment difference observed at the end of the feeder studies was maintained at specified time points in the delayed-start period.
Statistical Test of Hypothesis P-Value 0.974
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-1.14 to 1.11
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to 104-week Endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)
Hide Description ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant’s caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
Time Frame Baseline, Week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for ADCS-ADL.
Arm/Group Title Placebo Solanezumab
Hide Arm/Group Description:
Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
Overall Number of Participants Analyzed 420 456
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-26.77  (0.888) -24.77  (0.871)
4.Secondary Outcome
Title Change From Baseline to 104-week Endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Hide Description CDR-SB is a semi-structured interview of participants and their caregivers. Participant’s cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
Time Frame Baseline, Week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for CDR-SB.
Arm/Group Title Placebo Solanezumab
Hide Arm/Group Description:
Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
Overall Number of Participants Analyzed 416 452
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
5.59  (0.174) 5.27  (0.169)
5.Secondary Outcome
Title Change From Baseline to 104-week Endpoint in Neuropsychiatric Inventory (NPI)
Hide Description The NPI is a questionnaire administered to caregivers that quantifies behavioral changes in dementia. Each of the 12 behavioral domains the caregiver reports as present are scored for Frequency, scale: 1 (Occasionally) to 4 (Very Frequently), and Severity, scale: 1 (Mild) to 3 (Severe). If the domain is reported by the caregiver as 'Not Affected,' that domain is scored as 0. The individual domain scores are calculated by multiplying the frequency times the severity for each domain. NPI Total Score is calculated by adding the individual domain scores together for all 12 domains, with a scores range from 0 to 144. Lower scores indicated less severity and higher scores indicated a greater severity of neuropsychiatric disturbance. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
Time Frame Baseline, Week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for NPI.
Arm/Group Title Placebo Solanezumab
Hide Arm/Group Description:
Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
Overall Number of Participants Analyzed 414 457
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Mild Alzheimer’s Disease Number Analyzed 302 participants 323 participants
4.49  (0.788) 5.41  (0.773)
Moderate Alzheimer’s Disease Number Analyzed 112 participants 134 participants
11.90  (1.517) 8.10  (1.427)
6.Secondary Outcome
Title Change From Baseline to 104-week Endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) Caregiver Hours
Hide Description The RUD-Lite is a caregiver-completed assessment designed to assess the amount of formal and informal resources used by participants and the primary caregiver. It is completed by the caregiver and compiles data on the following resources: length of time the caregiver spends giving care, assisting participants with basic activities of daily living (BADL: eating dressing, grooming, bathing); assisting participants with instrumental activities of daily living (IADLs: shopping, cooking, housekeeping, laundry, transportation, taking medication, managing finances), and providing supervision. Scores range from 0 to 24 hours. Higher values indicate greater resource use. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
Time Frame Baseline, Week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for RUD-Lite.
Arm/Group Title Placebo Solanezumab
Hide Arm/Group Description:
Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
Overall Number of Participants Analyzed 415 451
Least Squares Mean (Standard Error)
Unit of Measure: hours per day (hr/day)
Mild Alzheimer’s Disease-Basic ADL Number Analyzed 302 participants 319 participants
1.96  (0.184) 1.21  (0.182)
Mild Alzheimer’s Disease-Instrumental ADL Number Analyzed 303 participants 319 participants
1.65  (0.207) 1.05  (0.205)
Mild Alzheimer’s Disease-Supervision Number Analyzed 303 participants 319 participants
2.84  (0.368) 2.59  (0.361)
Moderate Alzheimer’s Disease-Basic ADL Number Analyzed 112 participants 132 participants
3.19  (0.461) 3.54  (0.436)
Moderate Alzheimer’s Disease-Instrumental ADL Number Analyzed 112 participants 132 participants
1.75  (0.461) 1.72  (0.433)
Moderate Alzheimer’s Disease-Supervision Number Analyzed 112 participants 132 participants
5.03  (0.693) 4.47  (0.654)
7.Secondary Outcome
Title Change From Baseline to 104-week Endpoint in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy)
Hide Description EQ-5D (proxy version) is a generic, multidimensional, health-related, quality-of-life instrument assessing caregiver's impression of participants overall health state. Profile allows caregivers to rate participant's health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale: 1 (no problem), 2 (some problems), and 3 (major problems). These attribute combinations are converted into a weighted Health-State Index Score according to the United States (US) population-based algorithm. EQ-5D US Population-Based Index Scores range from -0.11 to 1.0. A score of 1.0 indicated perfect health. The Overall Health State Index Score is caregiver-reported using a visual analogue scale marked 0 (worst imaginable health) to 100 (best imaginable health state). LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
Time Frame Baseline, Week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for EQ-5D Proxy.
Arm/Group Title Placebo Solanezumab
Hide Arm/Group Description:
Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
Overall Number of Participants Analyzed 414 453
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Mild Alzheimer’s Disease Number Analyzed 303 participants 320 participants
-0.07  (0.010) -0.06  (0.009)
Moderate Alzheimer’s Disease Number Analyzed 111 participants 133 participants
-0.16  (0.020) -0.16  (0.019)
8.Secondary Outcome
Title Change From Baseline to 104-week Endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)
Hide Description The QoL-AD (Caregiver Total Score) is a disease-specific measure of quality of life for an Alzheimer's Disease (AD) population administered to the participant's primary caregiver, who answers on behalf of the participant. The assessment consists of 13 items covering physical health, energy, mood, living situations, memory, family, marriage, friends, chores, fun, money, self and life as a whole. The assessment is scored on a 4-point Likert scale with scores ranging from 1 (poor) to 4 (excellent). QoL-AD Total Score is defined as the sum of the 13 items with a scores range from 13 to 52. Higher scores denote a better quality of life. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
Time Frame Baseline, Week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for QoL-AD.
Arm/Group Title Placebo Solanezumab
Hide Arm/Group Description:
Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
Overall Number of Participants Analyzed 387 413
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
QLAD Self-Report Total Score-Mild Alzheimer’s Number Analyzed 273 participants 283 participants
-1.37  (0.331) -0.98  (0.327)
QLAD Caregiver Total Score-Mild Alzheimer’s Number Analyzed 284 participants 299 participants
-3.28  (0.350) -3.63  (0.345)
QLAD Self-Report Total Score-Moderate Alzheimer’s Number Analyzed 88 participants 94 participants
-2.52  (0.605) -2.34  (0.585)
QLAD Caregiver Total Score-Moderate Alzheimer’s Number Analyzed 103 participants 114 participants
-4.26  (0.573) -3.14  (0.552)
9.Secondary Outcome
Title Change From Baseline to 104-week Endpoint in Mini-Mental State Examination (MMSE)
Hide Description The MMSE is an instrument used to assess a participant's cognitive function. The instrument is divided into 2 sections. The first section measures orientation, memory, and attention with scores ranging from 0 to 21 (lower scores indicate greater impairment). The second section tests the ability of the participant to name objects, follow verbal and written commands, write a sentence, and copy figures with scores ranging from 0 to 9 (lower scores indicate greater impairment). The range for MMSE Total Score is 0 to 30. Lower scores indicate more impairment. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
Time Frame Baseline, Week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for MMSE.
Arm/Group Title Placebo Solanezumab
Hide Arm/Group Description:
Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
Overall Number of Participants Analyzed 412 446
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-8.08  (0.270) -7.60  (0.263)
10.Secondary Outcome
Title Change From Baseline to 52-week Endpoint in Plasma Amyloid Beta (Aβ) Levels
Hide Description Concentration of the peptide Aβ 1-40 and Aβ 1-42 in plasma measured by immunoassay. The immunoassays for plasma Aβ 1-40 and Aβ 1-42 peptides were modified to render them tolerant to the presence of Solanezumab which would otherwise interfere with non-modified assays. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
Time Frame Baseline, Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for plasma Aβ 1-40 and Aβ 1-42.
Arm/Group Title Placebo Solanezumab
Hide Arm/Group Description:
Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
Overall Number of Participants Analyzed 515 532
Least Squares Mean (Standard Error)
Unit of Measure: picograms per milliliter (pg/mL)
Aβ 1-40-Mild Alzheimer’s Disease Number Analyzed 358 participants 357 participants
176412.04  (3718.292) 173064.99  (3717.695)
Aβ 1-42-Mild Alzheimer’s Disease Number Analyzed 356 participants 356 participants
19854.92  (366.392) 19723.48  (368.644)
Aβ 1-40-Moderate Alzheimer’s Disease Number Analyzed 157 participants 174 participants
169356  (4627.8) 169087  (4511.6)
Aβ 1-42-Moderate Alzheimer’s Disease Number Analyzed 157 participants 176 participants
19237  (556.3) 19552  (528.7)
11.Secondary Outcome
Title Change From Baseline to 104-week Endpoint in Volumetric Magnetic Resonance Imaging (vMRI)
Hide Description The vMRI assessment of right and left hippocampal volume is reported. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
Time Frame Baseline, Week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for vMRI.
Arm/Group Title Placebo Solanezumab
Hide Arm/Group Description:
Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
Overall Number of Participants Analyzed 310 325
Least Squares Mean (Standard Error)
Unit of Measure: Cubic millimeter (mm³)
Right hippocampal volume-Mild Alzheimer’s Disease Number Analyzed 227 participants 231 participants
-230.23  (8.232) -230.07  (8.195)
Left hippocampal volume-Mild Alzheimer’s Disease Number Analyzed 227 participants 231 participants
-257.15  (8.153) -244.00  (8.115)
Right hippocampal volume-Moderate Alzheimer’s Number Analyzed 83 participants 94 participants
-261.39  (11.796) -256.52  (11.246)
Left hippocampal volume-Moderate Alzheimer’s Number Analyzed 83 participants 94 participants
-255.16  (11.466) -253.29  (10.858)
12.Secondary Outcome
Title Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive Subscore 11-Item Scale (ADAS-Cog11)
Hide Description The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer’s disease: orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
Time Frame Baseline, Week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for ADAS-Cog11.
Arm/Group Title Placebo Solanezumab
Hide Arm/Group Description:
Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
Overall Number of Participants Analyzed 375 409
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
17.78  (0.595) 17.38  (0.580)
13.Secondary Outcome
Title Mean Change From Baseline to Endpoint in Amyloid Imaging Parameters in Subjects With Mild Alzheimer’s Disease
Hide Description Florbetapir PET imaging was used to test for change from baseline. The hypothesis that amyloid burden was reduced in participants between the treatment groups from the feeder studies was tested. The change from baseline to the postbaseline visit of the composite summary standard uptake value ratio of florbetapir F18 was calculated. The composite summary measure is an unweighted average of the 6 smaller regions (anterior cingulate, frontal medial orbital, parietal, posterior cingulate, precuneus, and temporal) normalized to whole cerebellum and to subject-specific white matter.
Time Frame Baseline, Week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Feeder Intent-to-Treat Population: All randomized participants with mild Alzheimer's Disease from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for Amyloid Plaque Burden.
Arm/Group Title Placebo Solanezumab
Hide Arm/Group Description:
Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
Overall Number of Participants Analyzed 42 48
Mean (Standard Deviation)
Unit of Measure: Standard Uptake Value ratio (SUVr)
0.00  (0.131) -0.01  (0.222)
Time Frame [Not Specified]
Adverse Event Reporting Description There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
 
Arm/Group Title Placebo Solanezumab
Hide Arm/Group Description Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80. 400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
All-Cause Mortality
Placebo Solanezumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Solanezumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   308/723 (42.60%)      299/734 (40.74%)    
Blood and lymphatic system disorders     
Anaemia  1  3/723 (0.41%)  3 2/734 (0.27%)  2
Anaemia folate deficiency  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Coagulopathy  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Normochromic normocytic anaemia  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Cardiac disorders     
Acute myocardial infarction  1  4/723 (0.55%)  4 4/734 (0.54%)  5
Angina pectoris  1  2/723 (0.28%)  2 4/734 (0.54%)  5
Arrhythmia supraventricular  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Atrial fibrillation  1  5/723 (0.69%)  5 9/734 (1.23%)  9
Atrial flutter  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Atrioventricular block  1  2/723 (0.28%)  2 2/734 (0.27%)  2
Atrioventricular block second degree  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Bradycardia  1  1/723 (0.14%)  3 2/734 (0.27%)  2
Cardiac arrest  1  5/723 (0.69%)  5 5/734 (0.68%)  5
Cardiac failure  1  2/723 (0.28%)  2 3/734 (0.41%)  3
Cardiac failure acute  1  0/723 (0.00%)  0 2/734 (0.27%)  2
Cardiac failure congestive  1  6/723 (0.83%)  6 5/734 (0.68%)  5
Cardiac perforation  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Cardio-respiratory arrest  1  2/723 (0.28%)  2 2/734 (0.27%)  2
Cardiogenic shock  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Cardiomyopathy  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Cardiopulmonary failure  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Cardiovascular disorder  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Coronary artery stenosis  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Myocardial infarction  1  5/723 (0.69%)  5 4/734 (0.54%)  4
Palpitations  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Pericardial effusion  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Sinus bradycardia  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Sinus node dysfunction  1  4/723 (0.55%)  4 1/734 (0.14%)  1
Tachycardia  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Ventricular extrasystoles  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Ear and labyrinth disorders     
Vertigo  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Endocrine disorders     
Myxoedema  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Eye disorders     
Cataract  1  3/723 (0.41%)  3 2/734 (0.27%)  3
Glaucoma  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Retinal detachment  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Strabismus  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Vitreous haemorrhage  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Gastrointestinal disorders     
Abdominal hernia  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Abdominal pain  1  3/723 (0.41%)  3 0/734 (0.00%)  0
Abdominal pain upper  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Colitis ischaemic  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Colonic fistula  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Colonic pseudo-obstruction  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Constipation  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Diarrhoea  1  4/723 (0.55%)  4 0/734 (0.00%)  0
Diarrhoea haemorrhagic  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Diverticular fistula  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Diverticulum  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Duodenal ulcer  1  0/723 (0.00%)  0 2/734 (0.27%)  2
Dyspepsia  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Dysphagia  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Erosive oesophagitis  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Faecaloma  1  1/723 (0.14%)  1 3/734 (0.41%)  3
Gastric ulcer  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Gastric ulcer haemorrhage  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Gastritis  1  0/723 (0.00%)  0 2/734 (0.27%)  2
Gastrointestinal haemorrhage  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Gastrooesophageal reflux disease  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Haematochezia  1  0/723 (0.00%)  0 2/734 (0.27%)  2
Haemorrhoids  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Hiatus hernia  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Ileus  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Ileus paralytic  1  2/723 (0.28%)  2 0/734 (0.00%)  0
Inguinal hernia  1  2/723 (0.28%)  2 4/734 (0.54%)  4
Intestinal obstruction  1  1/723 (0.14%)  1 3/734 (0.41%)  3
Jejunal perforation  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Large intestine polyp  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Lower gastrointestinal haemorrhage  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Oesophageal perforation  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Oesophageal ulcer haemorrhage  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Pancreatitis  1  5/723 (0.69%)  5 3/734 (0.41%)  3
Pancreatitis acute  1  0/723 (0.00%)  0 2/734 (0.27%)  2
Peptic ulcer  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Rectal prolapse  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Rectal ulcer haemorrhage  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Small intestinal obstruction  1  3/723 (0.41%)  5 1/734 (0.14%)  1
Small intestinal perforation  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Subileus  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Upper gastrointestinal haemorrhage  1  2/723 (0.28%)  2 3/734 (0.41%)  3
Vomiting  1  2/723 (0.28%)  2 1/734 (0.14%)  1
General disorders     
Abasia  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Adverse drug reaction  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Asthenia  1  5/723 (0.69%)  5 2/734 (0.27%)  2
Catheter site haemorrhage  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Chest pain  1  2/723 (0.28%)  2 1/734 (0.14%)  1
Complication associated with device  1  2/723 (0.28%)  2 0/734 (0.00%)  0
Death  1  4/723 (0.55%)  4 1/734 (0.14%)  1
Drowning  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Gait disturbance  1  0/723 (0.00%)  0 1/734 (0.14%)  1
General physical health deterioration  1  2/723 (0.28%)  2 0/734 (0.00%)  0
Non-cardiac chest pain  1  2/723 (0.28%)  2 1/734 (0.14%)  1
Oedema peripheral  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Pain  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Pyrexia  1  1/723 (0.14%)  1 3/734 (0.41%)  3
Sudden death  1  3/723 (0.41%)  3 1/734 (0.14%)  1
Hepatobiliary disorders     
Bile duct obstruction  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Bile duct stone  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Cholangitis  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Cholecystitis  1  2/723 (0.28%)  2 0/734 (0.00%)  0
Cholecystitis acute  1  2/723 (0.28%)  2 2/734 (0.27%)  3
Cholelithiasis  1  2/723 (0.28%)  2 1/734 (0.14%)  1
Drug-induced liver injury  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Gallbladder polyp  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Hepatic steatosis  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Infections and infestations     
Abdominal abscess  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Appendicitis  1  0/723 (0.00%)  0 2/734 (0.27%)  2
Arthritis bacterial  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Bacteraemia  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Bacterial infection  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Bronchitis  1  0/723 (0.00%)  0 5/734 (0.68%)  5
Campylobacter gastroenteritis  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Cellulitis  1  1/723 (0.14%)  1 7/734 (0.95%)  8
Clostridium difficile colitis  1  2/723 (0.28%)  3 1/734 (0.14%)  1
Clostridium difficile infection  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Colostomy infection  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Cystitis  1  0/723 (0.00%)  0 2/734 (0.27%)  2
Device related infection  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Diverticulitis  1  4/723 (0.55%)  4 3/734 (0.41%)  3
Erysipelas  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Escherichia sepsis  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Escherichia urinary tract infection  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Extradural abscess  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Gastroenteritis  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Gastroenteritis viral  1  0/723 (0.00%)  0 3/734 (0.41%)  3
Groin abscess  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Herpes simplex encephalitis  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Herpes zoster  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Infected skin ulcer  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Influenza  1  2/723 (0.28%)  2 4/734 (0.54%)  4
Labyrinthitis  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Lower respiratory tract infection  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Lung infection  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Mediastinitis  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Meningitis bacterial  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Orchitis  1  0/317 (0.00%)  0 1/319 (0.31%)  1
Pericarditis tuberculous  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Pharyngitis  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Pneumonia  1  27/723 (3.73%)  31 27/734 (3.68%)  31
Pneumonia bacterial  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Pneumonia pneumococcal  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Post procedural infection  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Postoperative wound infection  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Pulmonary sepsis  1  3/723 (0.41%)  3 0/734 (0.00%)  0
Pulmonary tuberculosis  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Respiratory tract infection  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Sepsis  1  3/723 (0.41%)  4 6/734 (0.82%)  6
Septic shock  1  2/723 (0.28%)  2 1/734 (0.14%)  1
Sinusitis  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Tooth abscess  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Upper respiratory tract infection  1  0/723 (0.00%)  0 2/734 (0.27%)  2
Urinary tract infection  1  16/723 (2.21%)  21 17/734 (2.32%)  19
Urinary tract infection bacterial  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Urinary tract infection staphylococcal  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Urosepsis  1  3/723 (0.41%)  4 5/734 (0.68%)  7
Viral infection  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Wound infection  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Injury, poisoning and procedural complications     
Acetabulum fracture  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Ankle fracture  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Bone contusion  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Cervical vertebral fracture  1  2/723 (0.28%)  2 2/734 (0.27%)  3
Clavicle fracture  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Concussion  1  3/723 (0.41%)  3 1/734 (0.14%)  1
Contusion  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Craniocerebral injury  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Facial bones fracture  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Fall  1  27/723 (3.73%)  27 23/734 (3.13%)  25
Femoral neck fracture  1  4/723 (0.55%)  4 13/734 (1.77%)  13
Femur fracture  1  11/723 (1.52%)  11 3/734 (0.41%)  3
Fibula fracture  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Flail chest  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Foot fracture  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Forearm fracture  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Fractured ischium  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Head injury  1  2/723 (0.28%)  2 2/734 (0.27%)  2
Hip fracture  1  8/723 (1.11%)  8 11/734 (1.50%)  12
Humerus fracture  1  4/723 (0.55%)  4 1/734 (0.14%)  1
Incisional hernia  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Injury  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Joint dislocation  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Joint injury  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Laceration  1  3/723 (0.41%)  3 0/734 (0.00%)  0
Ligament sprain  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Lumbar vertebral fracture  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Patella fracture  1  2/723 (0.28%)  2 1/734 (0.14%)  1
Pelvic fracture  1  0/723 (0.00%)  0 4/734 (0.54%)  4
Periprosthetic fracture  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Pubis fracture  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Pulmonary contusion  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Radius fracture  1  2/723 (0.28%)  2 2/734 (0.27%)  2
Rib fracture  1  3/723 (0.41%)  3 0/734 (0.00%)  0
Road traffic accident  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Skull fracture  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Spinal column injury  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Spinal compression fracture  1  1/723 (0.14%)  1 2/734 (0.27%)  2
Spinal fracture  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Subdural haematoma  1  4/723 (0.55%)  4 5/734 (0.68%)  5
Subdural haemorrhage  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Tibia fracture  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Traumatic haematoma  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Traumatic intracranial haemorrhage  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Upper limb fracture  1  2/723 (0.28%)  2 1/734 (0.14%)  1
Wound  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Wound dehiscence  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Wrist fracture  1  0/723 (0.00%)  0 2/734 (0.27%)  2
Investigations     
Blood pressure increased  1  1/723 (0.14%)  3 0/734 (0.00%)  0
Hepatic enzyme increased  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Metabolism and nutrition disorders     
Adult failure to thrive  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Decreased appetite  1  3/723 (0.41%)  3 2/734 (0.27%)  2
Dehydration  1  7/723 (0.97%)  7 13/734 (1.77%)  15
Diabetes mellitus  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Failure to thrive  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Gout  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Hyperammonaemia  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Hyperglycaemia  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Hyperkalaemia  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Hypernatraemia  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Hyperosmolar hyperglycaemic state  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Hypoglycaemia  1  4/723 (0.55%)  4 0/734 (0.00%)  0
Hyponatraemia  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Hypophagia  1  1/723 (0.14%)  1 1/734 (0.14%)  2
Malnutrition  1  1/723 (0.14%)  1 2/734 (0.27%)  2
Type 2 diabetes mellitus  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Arthritis  1  2/723 (0.28%)  2 0/734 (0.00%)  0
Arthropathy  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Back pain  1  2/723 (0.28%)  2 2/734 (0.27%)  2
Cervical spinal stenosis  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Dupuytren's contracture  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Foot deformity  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Gouty arthritis  1  2/723 (0.28%)  2 0/734 (0.00%)  0
Intervertebral disc protrusion  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Joint effusion  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Joint swelling  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Lumbar spinal stenosis  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Muscle spasms  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Muscular weakness  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Osteoarthritis  1  7/723 (0.97%)  7 13/734 (1.77%)  14
Osteolysis  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Rhabdomyolysis  1  0/723 (0.00%)  0 1/734 (0.14%)  2
Rotator cuff syndrome  1  0/723 (0.00%)  0 2/734 (0.27%)  2
Spinal column stenosis  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Spondylolisthesis  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Basal cell carcinoma  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Benign soft tissue neoplasm  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Bladder cancer  1  1/723 (0.14%)  1 2/734 (0.27%)  2
Bladder cancer recurrent  1  0/723 (0.00%)  0 2/734 (0.27%)  2
Bladder transitional cell carcinoma  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Brain neoplasm  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Breast cancer  1  0/723 (0.00%)  0 3/734 (0.41%)  3
Breast cancer metastatic  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Chronic myeloid leukaemia  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Colon cancer  1  2/723 (0.28%)  2 0/734 (0.00%)  0
Colon cancer metastatic  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Essential thrombocythaemia  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Gastric cancer  1  1/723 (0.14%)  1 2/734 (0.27%)  2
Granular cell tumour  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Invasive ductal breast carcinoma  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Lung cancer metastatic  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Lung carcinoma cell type unspecified stage iv  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Lung neoplasm malignant  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Lymphoma  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Malignant melanoma  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Malignant neoplasm of unknown primary site  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Malignant neoplasm progression  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Metastases to liver  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Metastatic malignant melanoma  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Neoplasm  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Non-small cell lung cancer  1  3/723 (0.41%)  3 0/734 (0.00%)  0
Oesophageal adenocarcinoma  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Pancreatic carcinoma  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Pancreatic carcinoma metastatic  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Pancreatic neoplasm  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Papillary thyroid cancer  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Plasma cell myeloma  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Plasmacytoma  1  1/723 (0.14%)  3 0/734 (0.00%)  0
Prostate cancer metastatic  1  0/317 (0.00%)  0 1/319 (0.31%)  1
Rectal cancer  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Renal cell carcinoma  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Renal neoplasm  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Salivary gland neoplasm  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Squamous cell carcinoma of skin  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Uterine cancer  1  1/406 (0.25%)  1 0/415 (0.00%)  0
Nervous system disorders     
Altered state of consciousness  1  2/723 (0.28%)  2 0/734 (0.00%)  0
Brain stem haemorrhage  1  2/723 (0.28%)  2 0/734 (0.00%)  0
Brain stem infarction  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Cerebral haematoma  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Cerebral haemorrhage  1  3/723 (0.41%)  3 1/734 (0.14%)  1
Cerebral infarction  1  3/723 (0.41%)  3 4/734 (0.54%)  4
Cerebral microhaemorrhage  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Cerebrospinal fluid leakage  1  1/723 (0.14%)  3 0/734 (0.00%)  0
Cerebrovascular accident  1  1/723 (0.14%)  1 3/734 (0.41%)  3
Circadian rhythm sleep disorder  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Cognitive disorder  1  0/723 (0.00%)  0 3/734 (0.41%)  3
Coma  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Complex partial seizures  1  2/723 (0.28%)  2 0/734 (0.00%)  0
Dementia alzheimer's type  1  8/723 (1.11%)  8 5/734 (0.68%)  5
Dementia with lewy bodies  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Depressed level of consciousness  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Dizziness  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Encephalopathy  1  3/723 (0.41%)  4 1/734 (0.14%)  1
Epilepsy  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Generalised tonic-clonic seizure  1  2/723 (0.28%)  2 1/734 (0.14%)  1
Haemorrhage intracranial  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Haemorrhagic cerebral infarction  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Haemorrhagic stroke  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Headache  1  3/723 (0.41%)  3 1/734 (0.14%)  1
Hemiparesis  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Hypoxic-ischaemic encephalopathy  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Intracranial aneurysm  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Intraventricular haemorrhage  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Ischaemic cerebral infarction  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Ischaemic stroke  1  6/723 (0.83%)  6 0/734 (0.00%)  0
Lethargy  1  0/723 (0.00%)  0 2/734 (0.27%)  2
Loss of consciousness  1  2/723 (0.28%)  2 1/734 (0.14%)  1
Metabolic encephalopathy  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Myoclonus  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Normal pressure hydrocephalus  1  2/723 (0.28%)  2 1/734 (0.14%)  1
Presyncope  1  2/723 (0.28%)  2 2/734 (0.27%)  2
Seizure  1  3/723 (0.41%)  3 11/734 (1.50%)  13
Somnolence  1  0/723 (0.00%)  0 2/734 (0.27%)  2
Subarachnoid haemorrhage  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Syncope  1  10/723 (1.38%)  10 15/734 (2.04%)  16
Transient ischaemic attack  1  3/723 (0.41%)  3 2/734 (0.27%)  2
Tremor  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Vasogenic cerebral oedema  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Psychiatric disorders     
Abnormal behaviour  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Affective disorder  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Aggression  1  2/723 (0.28%)  2 2/734 (0.27%)  7
Agitation  1  11/723 (1.52%)  11 7/734 (0.95%)  7
Alcohol abuse  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Behavioural and psychiatric symptoms of dementia  1  7/723 (0.97%)  10 3/734 (0.41%)  3
Bipolar disorder  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Completed suicide  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Confusional state  1  1/723 (0.14%)  1 6/734 (0.82%)  6
Delirium  1  5/723 (0.69%)  5 5/734 (0.68%)  5
Delirium febrile  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Delusion  1  3/723 (0.41%)  3 2/734 (0.27%)  2
Delusional perception  1  0/723 (0.00%)  0 1/734 (0.14%)  3
Disorientation  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Insomnia  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Irritability  1  3/723 (0.41%)  4 0/734 (0.00%)  0
Major depression  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Mental status changes  1  5/723 (0.69%)  5 2/734 (0.27%)  2
Restlessness  1  2/723 (0.28%)  2 0/734 (0.00%)  0
Suicidal behaviour  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Suicidal ideation  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Suicide attempt  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Renal and urinary disorders     
Acute kidney injury  1  6/723 (0.83%)  6 2/734 (0.27%)  2
Acute prerenal failure  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Bladder tamponade  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Calculus bladder  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Haematuria  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Hydronephrosis  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Nephrolithiasis  1  2/723 (0.28%)  2 1/734 (0.14%)  1
Renal failure  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Urinary bladder haemorrhage  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Urinary retention  1  3/723 (0.41%)  3 3/734 (0.41%)  3
Reproductive system and breast disorders     
Acquired hydrocele  1  0/317 (0.00%)  0 1/319 (0.31%)  1
Benign prostatic hyperplasia  1  2/317 (0.63%)  2 1/319 (0.31%)  1
Cystocele  1  1/406 (0.25%)  1 0/415 (0.00%)  0
Prostatomegaly  1  0/317 (0.00%)  0 1/319 (0.31%)  1
Uterine prolapse  1  1/406 (0.25%)  1 0/415 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Acute respiratory failure  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Aspiration  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Bronchospasm  1  0/723 (0.00%)  0 1/734 (0.14%)  2
Chronic obstructive pulmonary disease  1  2/723 (0.28%)  2 1/734 (0.14%)  1
Dyspnoea  1  3/723 (0.41%)  3 1/734 (0.14%)  1
Hypoxia  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Interstitial lung disease  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Lung disorder  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Nasal polyps  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Organising pneumonia  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Pharyngeal oedema  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Pleural effusion  1  4/723 (0.55%)  4 0/734 (0.00%)  0
Pneumonia aspiration  1  5/723 (0.69%)  5 5/734 (0.68%)  6
Pneumothorax  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Pneumothorax spontaneous  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Pulmonary embolism  1  1/723 (0.14%)  1 6/734 (0.82%)  6
Respiratory distress  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Respiratory failure  1  2/723 (0.28%)  2 3/734 (0.41%)  3
Skin and subcutaneous tissue disorders     
Dermatitis contact  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Diabetic foot  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Drug eruption  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Hypersensitivity vasculitis  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Sebaceous gland disorder  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Urticaria  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Social circumstances     
Activities of daily living impaired  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Surgical and medical procedures     
Cataract operation  1  1/723 (0.14%)  2 0/734 (0.00%)  0
Vascular disorders     
Aortic aneurysm  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Aortic stenosis  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Arterial thrombosis  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Arteriosclerosis  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Deep vein thrombosis  1  1/723 (0.14%)  1 6/734 (0.82%)  7
Haematoma  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Hypertensive crisis  1  1/723 (0.14%)  2 1/734 (0.14%)  1
Hypotension  1  1/723 (0.14%)  1 1/734 (0.14%)  1
Peripheral artery thrombosis  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Peripheral ischaemia  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Shock  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Thromboangiitis obliterans  1  0/723 (0.00%)  0 1/734 (0.14%)  1
Thrombophlebitis  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Venous thrombosis  1  1/723 (0.14%)  1 0/734 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Solanezumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   485/723 (67.08%)      514/734 (70.03%)    
Gastrointestinal disorders     
Constipation  1  51/723 (7.05%)  56 64/734 (8.72%)  71
Diarrhoea  1  58/723 (8.02%)  72 76/734 (10.35%)  105
Vomiting  1  41/723 (5.67%)  51 51/734 (6.95%)  70
General disorders     
Oedema peripheral  1  31/723 (4.29%)  33 37/734 (5.04%)  38
Infections and infestations     
Bronchitis  1  32/723 (4.43%)  47 43/734 (5.86%)  56
Nasopharyngitis  1  78/723 (10.79%)  129 88/734 (11.99%)  145
Upper respiratory tract infection  1  59/723 (8.16%)  73 47/734 (6.40%)  61
Urinary tract infection  1  98/723 (13.55%)  153 84/734 (11.44%)  161
Injury, poisoning and procedural complications     
Contusion  1  45/723 (6.22%)  62 58/734 (7.90%)  84
Fall  1  145/723 (20.06%)  222 136/734 (18.53%)  245
Investigations     
Weight decreased  1  48/723 (6.64%)  51 38/734 (5.18%)  40
Metabolism and nutrition disorders     
Decreased appetite  1  35/723 (4.84%)  39 37/734 (5.04%)  44
Musculoskeletal and connective tissue disorders     
Arthralgia  1  42/723 (5.81%)  51 33/734 (4.50%)  40
Back pain  1  49/723 (6.78%)  54 67/734 (9.13%)  75
Nervous system disorders     
Cerebral microhaemorrhage  1  42/723 (5.81%)  47 56/734 (7.63%)  61
Dizziness  1  39/723 (5.39%)  43 43/734 (5.86%)  53
Headache  1  49/723 (6.78%)  65 46/734 (6.27%)  64
Psychiatric disorders     
Agitation  1  75/723 (10.37%)  83 64/734 (8.72%)  72
Anxiety  1  56/723 (7.75%)  78 86/734 (11.72%)  114
Insomnia  1  67/723 (9.27%)  70 74/734 (10.08%)  80
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  17/317 (5.36%)  17 9/319 (2.82%)  10
Respiratory, thoracic and mediastinal disorders     
Cough  1  50/723 (6.92%)  61 66/734 (8.99%)  74
Vascular disorders     
Hypertension  1  42/723 (5.81%)  43 36/734 (4.90%)  38
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01127633     History of Changes
Other Study ID Numbers: 11935
H8A-MC-LZAO ( Other Identifier: Eli Lilly and Company )
First Submitted: May 19, 2010
First Posted: May 21, 2010
Results First Submitted: February 12, 2018
Results First Posted: May 3, 2018
Last Update Posted: June 5, 2018