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Trial record 12 of 1900 for:    Diseases | ( Map: Puerto Rico )

A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease (ExpeditionPRO)

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ClinicalTrials.gov Identifier: NCT02760602
Recruitment Status : Terminated (Insufficient scientific evidence that solanezumab would likely demonstrate a meaningful benefit to participants with prodromal AD as defined by study protocol.)
First Posted : May 3, 2016
Results First Posted : July 24, 2018
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Interventions Drug: Solanezumab
Drug: Placebo
Enrollment 26
Recruitment Details  
Pre-assignment Details Participants were randomized by site and by use of florbetapir positron emission tomography (PET) scanning or cerebrospinal fluid (CSF) for study eligibility.
Arm/Group Title Solanezumab Placebo
Hide Arm/Group Description Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years. Placebo given IV once every 4 weeks for up to 2 years.
Period Title: Overall Study
Started 13 13
Completed 0 0
Not Completed 13 13
Reason Not Completed
Withdrawal by Subject             1             0
Terminated by sponsor             12             13
Arm/Group Title Solanezumab Placebo Total
Hide Arm/Group Description Solanezumab given IV once every 4 weeks for up to 2 years. Placebo given IV once every 4 weeks for up to 2 years. Total of all reporting groups
Overall Number of Baseline Participants 13 13 26
Hide Baseline Analysis Population Description
All enrolled participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 26 participants
73.46  (6.01) 75.62  (4.93) 74.54  (5.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Female 4 6 10
Male 9 7 16
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Hispanic or Latino 0 0 0
Not Hispanic or Latino 12 13 25
Unknown or Not Reported 1 0 1
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
American Indian or Alaska Native 0 0 0
Asian 3 0 3
Native Hawaiian or Other Pacific Islander 1 0 1
Black or African American 0 1 1
White 9 12 21
More than one race 0 0 0
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
United States 10 11 21
Japan 2 0 2
Canada 1 0 1
Poland 0 2 2
ADAS-Cog14 at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 13 participants 13 participants 26 participants
24.08  (8.00) 27.77  (3.63) 25.92  (6.37)
[1]
Measure Description: ADAS-Cog14 is ADAS-Cog11 augmented with orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze-completion measures. The ADAS-Cog14 scale ranges from 0 to 90. Higher scores indicate greater disease severity.
1.Primary Outcome
Title Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score
Hide Description ADAS-Cog14 is ADAS-Cog11 augmented with orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze-completion measures. The ADAS-Cog14 scale ranges from 0 to 90. Higher scores indicate greater disease severity.
Time Frame Baseline, 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as no data collected.
Arm/Group Title Solanezumab Placebo
Hide Arm/Group Description:
Solanezumab given IV once every 4 weeks for up to 2 years.
Placebo given IV once every 4 weeks for up to 2 years.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)
Hide Description The ADCS-MCI-ADL is a functional evaluation scale for MCI patients, based on information provided by an informant that describes the performance of participants in several ADLs. Total score ranges from 0 to 69; lower score indicates greater disease severity.
Time Frame Baseline, 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as no data collected.
Arm/Group Title Solanezumab Placebo
Hide Arm/Group Description:
Solanezumab given IV once every 4 weeks for up to 2 years.
Placebo given IV once every 4 weeks for up to 2 years.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change From Baseline on the Mini Mental Status Examination (MMSE)
Hide Description MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants.Total score ranges from 0 to 30; lower score indicates greater disease severity.
Time Frame Baseline, 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as no data collected.
Arm/Group Title Solanezumab Placebo
Hide Arm/Group Description:
Solanezumab given IV once every 4 weeks for up to 2 years.
Placebo given IV once every 4 weeks for up to 2 years.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change From Baseline on the Montreal Cognitive Assessment (MoCA)
Hide Description The MoCA will be used as the global cognitive screening instrument. It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition. Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition.
Time Frame Baseline, 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as no data collected.
Arm/Group Title Solanezumab Placebo
Hide Arm/Group Description:
Solanezumab given IV once every 4 weeks for up to 2 years.
Placebo given IV once every 4 weeks for up to 2 years.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change From Baseline on the Functional Activities Questionnaire (FAQ)
Hide Description FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant’s ability to perform a variety of activities ranging from Writing checks, Assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, Traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did [the activity] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3). The maximum FAQ total score is 30, with higher scores indicating greater impairment.
Time Frame Baseline, 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as no data collected.
Arm/Group Title Solanezumab Placebo
Hide Arm/Group Description:
Solanezumab given IV once every 4 weeks for up to 2 years.
Placebo given IV once every 4 weeks for up to 2 years.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change From Baseline on the Neuropsychiatric Inventory (NPI)
Hide Description The NPI is a tool for assessing psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant’s behavior. The score ranges from 12 to 144, with higher scores indicating greater disease severity.
Time Frame Baseline, 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as no data collected.
Arm/Group Title Solanezumab Placebo
Hide Arm/Group Description:
Solanezumab given IV once every 4 weeks for up to 2 years.
Placebo given IV once every 4 weeks for up to 2 years.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Change From Baseline on the Clinical Dementia Rating Scale 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.
Time Frame Baseline, 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as no data collected.
Arm/Group Title Solanezumab Placebo
Hide Arm/Group Description:
Solanezumab given IV once every 4 weeks for up to 2 years.
Placebo given IV once every 4 weeks for up to 2 years.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Change From Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Hide Description RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial/constructional skills.
Time Frame Baseline, 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as no data collected.
Arm/Group Title Solanezumab Placebo
Hide Arm/Group Description:
Solanezumab given IV once every 4 weeks for up to 2 years.
Placebo given IV once every 4 weeks for up to 2 years.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Change From Baseline on the Free and Cued Selective Reminding Test (FCSRT)
Time Frame Baseline, 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as no data collected.
Arm/Group Title Solanezumab Placebo
Hide Arm/Group Description:
Solanezumab given IV once every 4 weeks for up to 2 years.
Placebo given IV once every 4 weeks for up to 2 years.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Change From Baseline on the Resource Utilization in Dementia–Lite (RUD-Lite)
Hide Description RUD-Lite assesses the healthcare resource utilization of participants and their caregivers to determine the level of formal and informal care attributable to Alzheimer's Disease (AD). Information on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) is collected from the baseline and follow-up interviews.
Time Frame Baseline, 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as no data collected.
Arm/Group Title Solanezumab Placebo
Hide Arm/Group Description:
Solanezumab given IV once every 4 weeks for up to 2 years.
Placebo given IV once every 4 weeks for up to 2 years.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Change From Baseline on the EuroQol 5-Dimensional Health-Related Quality of Life Scale (EQ-5D)
Hide Description EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Visual analogue scale (VAS) assesses caregiver's impression of participant's overall health state; scores range: 0 to 100. Lower scores indicate greater disease severity.
Time Frame Baseline, 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as no data collected.
Arm/Group Title Solanezumab Placebo
Hide Arm/Group Description:
Solanezumab given IV once every 4 weeks for up to 2 years.
Placebo given IV once every 4 weeks for up to 2 years.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Change From Baseline on the Quality of Life in Alzheimer’s Disease Scale (QoL-AD)
Hide Description QoL for AD assess participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items rated on a 4-point scale. Sum of items=total score (range: 13-52). Higher scores=greater QoL.
Time Frame Baseline, 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as no data collected.
Arm/Group Title Solanezumab Placebo
Hide Arm/Group Description:
Solanezumab given IV once every 4 weeks for up to 2 years.
Placebo given IV once every 4 weeks for up to 2 years.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Change From Baseline in Concentration of Plasma Amyloid-β Peptide (Aβ) and Plasma Solanezumab
Hide Description Concentration of amino acid peptide known as Aβ 1-42 in plasma.
Time Frame Baseline, 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as no data collected.
Arm/Group Title Solanezumab Placebo
Hide Arm/Group Description:
Solanezumab given IV once every 4 weeks for up to 2 years.
Placebo given IV once every 4 weeks for up to 2 years.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)
Hide Description MRI will be used to assess the effect of treatment on rate of whole brain volume.
Time Frame Baseline, 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as no data collected.
Arm/Group Title Solanezumab Placebo
Hide Arm/Group Description:
Solanezumab given IV once every 4 weeks for up to 2 years.
Placebo given IV once every 4 weeks for up to 2 years.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Change From Baseline in Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr)
Hide Description Florbetapir F18 PET used to assess the treatment effect in brain amyloid plaque deposition from baseline through 18 months as measured by florbetapir F18 PET Standardized Uptake Uptake Value ratio.
Time Frame Baseline, 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as no data collected.
Arm/Group Title Solanezumab Placebo
Hide Arm/Group Description:
Solanezumab given IV once every 4 weeks for up to 2 years.
Placebo given IV once every 4 weeks for up to 2 years.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Aβ and CSF Tau Proteins
Hide Description Changes in CSF parameters, including total and free Aβ1-40 and Aβ1-42 species and total tau and P-tau181 peptides, will be assessed.
Time Frame Baseline, 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as no data collected.
Arm/Group Title Solanezumab Placebo
Hide Arm/Group Description:
Solanezumab given IV once every 4 weeks for up to 2 years.
Placebo given IV once every 4 weeks for up to 2 years.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Change From Baseline in Neocortical Tau Deposits Using 18F-AV-1451 PET
Hide Description Biomarker change will be analyzed to provide biomarker-based evidence that solanezumab affects the underlying disease pathology.
Time Frame Baseline, 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as no data collected.
Arm/Group Title Solanezumab Placebo
Hide Arm/Group Description:
Solanezumab given IV once every 4 weeks for up to 2 years.
Placebo given IV once every 4 weeks for up to 2 years.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline to Study Termination (Up To 11 Months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Solanezumab Placebo
Hide Arm/Group Description Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years. Placebo given IV once every 4 weeks for up to 2 years.
All-Cause Mortality
Solanezumab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)      0/13 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Solanezumab Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/13 (15.38%)      1/13 (7.69%)    
Cardiac disorders     
Coronary artery disease  1  1/13 (7.69%)  1 0/13 (0.00%)  0
Infections and infestations     
Pneumonia  1  0/13 (0.00%)  0 1/13 (7.69%)  1
Nervous system disorders     
Syncope  1  1/13 (7.69%)  1 0/13 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Solanezumab Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/13 (53.85%)      1/13 (7.69%)    
Cardiac disorders     
Coronary artery disease  1  1/13 (7.69%)  2 0/13 (0.00%)  0
Gastrointestinal disorders     
Constipation  1  1/13 (7.69%)  1 0/13 (0.00%)  0
General disorders     
Extravasation  1  1/13 (7.69%)  2 0/13 (0.00%)  0
Infections and infestations     
Upper respiratory tract infection  1  2/13 (15.38%)  2 1/13 (7.69%)  1
Viral upper respiratory tract infection  1  1/13 (7.69%)  1 0/13 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  1/13 (7.69%)  1 0/13 (0.00%)  0
Skin abrasion  1  1/13 (7.69%)  4 0/13 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Spinal osteoarthritis  1  1/13 (7.69%)  1 0/13 (0.00%)  0
Psychiatric disorders     
Insomnia  1  1/13 (7.69%)  1 0/13 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary hypertension  1  1/13 (7.69%)  1 0/13 (0.00%)  0
Upper-airway cough syndrome  1  0/13 (0.00%)  0 1/13 (7.69%)  1
Surgical and medical procedures     
Endodontic procedure  1  1/13 (7.69%)  1 0/13 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
The study was terminated due to insufficient scientific evidence that solanezumab would likely demonstrate a meaningful benefit to pts with prodromal AD as defined by the study protocol. Zero pts were analyzed as no data collected for outcomes.
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.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
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: NCT02760602     History of Changes
Other Study ID Numbers: 16349
H8A-MC-LZBE ( Other Identifier: Eli Lilly and Company )
2016-000108-27 ( EudraCT Number )
First Submitted: May 2, 2016
First Posted: May 3, 2016
Results First Submitted: May 8, 2018
Results First Posted: July 24, 2018
Last Update Posted: July 24, 2018