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ELND005 in Patients With Mild to Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
Transition Therapeutics
Information provided by (Responsible Party):
Transition Therapeutics Ireland Limited
ClinicalTrials.gov Identifier:
NCT00568776
First received: December 4, 2007
Last updated: April 11, 2016
Last verified: April 2016
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
No text entered.

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.
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
Total Total of all reporting groups

Baseline Measures
   Placebo BID   ELND005 250 mg BID   ELND005 1000 mg BID   ELND005 2000 mg BID   Total 
Overall Participants Analyzed 
[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