ELND005 in Patients With Mild to Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
Transition Therapeutics
Information provided by (Responsible Party):
Elan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00568776
First received: December 4, 2007
Last updated: March 1, 2012
Last verified: March 2012
Results First Received: September 27, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer Disease
Interventions: Drug: Placebo Control
Drug: ELND005

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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 BID oral administration for 78 weeks
ELND005 250 mg BID oral administration for 78 weeks
ELND005 1000 mg BID oral administration for 78 weeks
ELND005 2000 mg BID oral administration for 78 weeks

Participant Flow:   Overall Study
    Placebo BID     ELND005 250 mg BID     ELND005 1000 mg BID     ELND005 2000 mg BID  
STARTED     83 [1]   88 [2]   89 [3]   91 [4]
COMPLETED     53     52     15     19  
NOT COMPLETED     30     36     74     72  
Adverse Event                 8                 8                 10                 8  
Death                 0                 1                 4                 3  
Physician Decision                 0                 2                 0                 0  
Lack of Efficacy                 2                 2                 2                 4  
Lost to Follow-up                 1                 1                 1                 1  
Protocol Violation                 1                 0                 1                 1  
Withdrawal by Subject                 13                 15                 13                 7  
Loss of Caregiver                 0                 2                 1                 2  
Sponsor Decision                 2                 2                 41                 42  
Miscellaeneous                 3                 3                 1                 4  
[1] One randomized patient withdrew consent and did not receive placebo
[2] One randomized patient withdrew consent and did not receive ELND005 250 mg BID
[3] 41 patients withdrawn per interim safety review (sponsors decision); excluded in efficacy analysis.
[4] 42 patients withdrawn per interim safety review (sponsors decision); excluded in efficacy analysis.



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Placebo BID oral administration for 78 weeks
ELND005 250 mg BID oral administration for 78 weeks
ELND005 1000 mg BID oral administration for 78 weeks
ELND005 2000 mg BID oral administration for 78 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo BID     ELND005 250 mg BID     ELND005 1000 mg BID     ELND005 2000 mg BID     Total  
Number of Participants  
[units: participants]
  83     88     89     91     351  
Age  
[units: years]
Mean ± Standard Deviation
  73.4  ± 7.83     73.4  ± 7.26     73.4  ± 7.56     72.2  ± 8.20     73.1  ± 7.7  
Gender  
[units: patients]
         
Female     47     51     48     51     197  
Male     36     37     41     40     154  
Region of Enrollment  
[units: patients]
         
United States     68     75     71     75     289  
Canada     15     13     18     16     62  



  Outcome Measures
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1.  Primary:   Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS)   [ Time Frame: Baseline and 78 weeks ]

2.  Primary:   Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS)   [ Time Frame: Baseline and 78 weeks ]

3.  Primary:   Change From Baseline to Week 78 in Alzheimer‘s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS)   [ Time Frame: Baseline and 78 weeks ]

4.  Primary:   Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Alzheimer‘s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) Score (Per Protocol Set; PPS)   [ Time Frame: Baseline and 78 weeks ]

5.  Secondary:   Change in Alzheimer‘s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS)   [ Time Frame: Baseline and 78 weeks ]

6.  Secondary:   Change in Clinical Dementia Rating – Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS)   [ Time Frame: Baseline and 78 weeks ]

7.  Secondary:   Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS)   [ Time Frame: Baseline and 78 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The two high dose groups of ELND005 were discontinued before study end, so the efficacy analysis was based only on placebo and ELND005 250 mg bid groups.


  More Information