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Trial record 16 of 31 for:    alzheimer dijon

Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo (EXPEDITION 3)

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ClinicalTrials.gov Identifier: NCT01900665
Recruitment Status : Terminated (Solanezumab did not meet the study's primary endpoint.)
First Posted : July 16, 2013
Results First Posted : March 14, 2018
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: Solanezumab
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were excluded after study enrollment,if PET imaging or CSF results did not show evidence of brain amyloid pathology,a screening MRI with results >4 ARIA-H(amyloid-related imaging abnormality-hemorrhage/hemosiderin deposition) or presence of ARIA-E(amyloid-related imaging abnormality-edema/effusions) and abnormal lab results were found.

Reporting Groups
  Description
Solanezumab Participants received Solanezumab 400 milligrams (mg)Intravenously (IV) every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
Placebo Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.

Participant Flow for 2 periods

Period 1:   Placebo Controlled Period
    Solanezumab   Placebo
STARTED   1057   1072 
Received at Least 1 Dose of Study Drug   1054   1067 
COMPLETED   914   908 
NOT COMPLETED   143   164 
Death                9                16 
Adverse Event                48                39 
Protocol Violation                1                7 
Withdrawal by Subject                33                45 
Physician Decision                11                7 
Lost to Follow-up                3                0 
Caregiver Decision                33                41 
Entry Criteria Not Met                5                9 

Period 2:   Open Label Period
    Solanezumab   Placebo
STARTED   881 [1]   859 [1] 
COMPLETED   0   0 
NOT COMPLETED   881   859 
Adverse Event                16                20 
Death                5                6 
Lost to Follow-up                1                1 
Parent/Caregiver Decision                33                34 
Physician Decision                4                4 
Protocol Violation                0                1 
Sponsor Decision                802                765 
Withdrawal by Subject                20                28 
[1] Patients from Placebo Controlled Period were not required to enter into Open Label Period.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants.

Reporting Groups
  Description
Solanezumab Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
Placebo

Placebo every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.

Placebo: Administered IV

Total Total of all reporting groups

Baseline Measures
   Solanezumab   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 1057   1072   2129 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed   1057   1072   2129 
   72.69  (7.814)   73.26  (7.966)   72.98  (7.894) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed   1057   1072   2129 
Female   600   631   1231 
Male   457   441   898 
Ethnicity (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   970   986   1956 
Hispanic or Latino   49   49   98 
Not Hispanic or Latino   921   937   1858 
Unknown or Not Reported   0   0   0 
[1] All randomized participants who had baseline ethnicity data.
Race (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   970   986   1956 
American Indian or Alaska Native   0   0   0 
Asian   75   71   146 
Native Hawaiian or Other Pacific Islander   1   0   1 
Black or African American   14   19   33 
White   878   894   1772 
More than one race   2   2   4 
Unknown or Not Reported   0   0   0 
[1] All randomized participants who had baseline race data.
Region of Enrollment 
[Units: Participants]
Count of Participants
     
Canada       
Participants Analyzed   1057   1072   2129 
Canada   61   66   127 
Sweden       
Participants Analyzed   1057   1072   2129 
Sweden   26   26   52 
United States       
Participants Analyzed   1057   1072   2129 
United States   537   541   1078 
Japan       
Participants Analyzed   1057   1072   2129 
Japan   67   65   132 
Poland       
Participants Analyzed   1057   1072   2129 
Poland   52   50   102 
Italy       
Participants Analyzed   1057   1072   2129 
Italy   46   52   98 
United Kingdom       
Participants Analyzed   1057   1072   2129 
United Kingdom   45   44   89 
Australia       
Participants Analyzed   1057   1072   2129 
Australia   32   36   68 
France       
Participants Analyzed   1057   1072   2129 
France   87   86   173 
Germany       
Participants Analyzed   1057   1072   2129 
Germany   48   48   96 
Spain       
Participants Analyzed   1057   1072   2129 
Spain   56   58   114 


  Outcome Measures

1.  Primary:   Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 14 Item Subscore (ADAS-Cog14)   [ Time Frame: Baseline, Week 80 ]

2.  Secondary:   Change From Baseline in Alzheimer's Disease Cooperative Study- Instrumental Activities of Daily Living (ADCS-iADL)   [ Time Frame: Baseline, Week 80 ]

3.  Secondary:   Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 11 Item Subscore (ADAS-Cog11)   [ Time Frame: Baseline, Week 80 ]

4.  Secondary:   Change From Baseline in Mini-Mental State Examination (MMSE)   [ Time Frame: Baseline, Week 80 ]

5.  Secondary:   Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)   [ Time Frame: Baseline, Week 80 ]

6.  Secondary:   Change From Baseline in Functional Activities Questionnaire (FAQ)   [ Time Frame: Baseline, Week 80 ]

7.  Secondary:   Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB)   [ Time Frame: Baseline, Week 80 ]

8.  Secondary:   Change From Baseline in Neuropsychiatric Inventory (NPI)   [ Time Frame: Baseline, Week 80 ]

9.  Secondary:   Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite)   [ Time Frame: Baseline, Week 80 ]

10.  Secondary:   Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD)   [ Time Frame: Baseline, Week 80 ]

11.  Secondary:   Change From Baseline in 5-Dimensional EuroQol Quality of Life Scale Proxy Version (EQ-5D Proxy)   [ Time Frame: Baseline, Week 80 ]

12.  Secondary:   Change From Baseline in Integrated Alzheimer’s Disease Rating Scale (iADRS)   [ Time Frame: Baseline, Week 80 ]

13.  Secondary:   Percentage of Participants of Cognitive and Functional Responders   [ Time Frame: Baseline through Week 80 ]

14.  Secondary:   Change From Baseline in Plasma Amyloid-Beta (Aβ) Species   [ Time Frame: Baseline, Week 80 ]

15.  Secondary:   Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)   [ Time Frame: Baseline, Week 80 ]

16.  Secondary:   Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Solanezumab (LY2062430)   [ Time Frame: Visit 2 (Post-dose), Visit 5, 9, 15 (Pre-dose, Post-dose) and Visit 22 (Pre-dose): Pre-dose before the infusion, Post-dose 30 minutes End of Infusion ]

17.  Secondary:   Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan   [ Time Frame: Baseline, Week 80 ]

18.  Secondary:   Change From Baseline in Cerebrospinal Fluid (CSF) Aβ Levels   [ Time Frame: Baseline, Week 80 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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 agreement is:
unchecked 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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked 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. 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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01900665     History of Changes
Other Study ID Numbers: 15136
H8A-MC-LZAX ( Other Identifier: Eli Lilly and Company )
First Submitted: July 12, 2013
First Posted: July 16, 2013
Results First Submitted: February 16, 2018
Results First Posted: March 14, 2018
Last Update Posted: May 3, 2018