ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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 : 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: None (Open Label);   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
Participants who completed one of the feeder studies (Study LZAM or Study LZAN) were enrolled in this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Participants were from feeder studies (LZAM or LZAN).
Solanezumab 400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.

Participant Flow:   Overall Study
    Placebo   Solanezumab
STARTED   723   734 
Received at Least 1 Dose of Study Drug   723   734 
COMPLETED   70   61 
NOT COMPLETED   653   673 
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 



  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 who received at least 1 dose of study drug.

Reporting Groups
  Description
Placebo Participants were from feeder studies (LZAM or LZAN).
Solanezumab 400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
Total Total of all reporting groups

Baseline Measures
   Placebo   Solanezumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 723   734   1457 
Age 
[Units: Years]
Mean (Standard Deviation)
 73.10  (8.004)   72.96  (7.766)   73.03  (7.883) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   406   415   821 
Male   317   319   636 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of 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 


  Outcome Measures

1.  Primary:   Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)   [ Time Frame: Baseline through Week 104 ]

2.  Secondary:   Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14)   [ Time Frame: Baseline, Week 104 ]

3.  Secondary:   Change From Baseline to 104-week Endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)   [ Time Frame: Baseline, Week 104 ]

4.  Secondary:   Change From Baseline to 104-week Endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB)   [ Time Frame: Baseline, Week 104 ]

5.  Secondary:   Change From Baseline to 104-week Endpoint in Neuropsychiatric Inventory (NPI)   [ Time Frame: Baseline, Week 104 ]

6.  Secondary:   Change From Baseline to 104-week Endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) Caregiver Hours   [ Time Frame: Baseline, Week 104 ]

7.  Secondary:   Change From Baseline to 104-week Endpoint in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy)   [ Time Frame: Baseline, Week 104 ]

8.  Secondary:   Change From Baseline to 104-week Endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)   [ Time Frame: Baseline, Week 104 ]

9.  Secondary:   Change From Baseline to 104-week Endpoint in Mini-Mental State Examination (MMSE)   [ Time Frame: Baseline, Week 104 ]

10.  Secondary:   Change From Baseline to 52-week Endpoint in Plasma Amyloid Beta (Aβ) Levels   [ Time Frame: Baseline, Week 52 ]

11.  Secondary:   Change From Baseline to 104-week Endpoint in Volumetric Magnetic Resonance Imaging (vMRI)   [ Time Frame: Baseline, Week 104 ]

12.  Secondary:   Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive Subscore 11-Item Scale (ADAS-Cog11)   [ Time Frame: Baseline, Week 104 ]

13.  Secondary:   Mean Change From Baseline to Endpoint in Amyloid Imaging Parameters in Subjects With Mild Alzheimer’s Disease   [ Time Frame: Baseline, Week 104 ]


  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 Other disclosure agreement that restricts the right of the PI 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: May 3, 2018