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Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Transition Therapeutics Ireland Limited
ClinicalTrials.gov Identifier:
NCT01735630
First received: November 25, 2012
Last updated: July 6, 2016
Last verified: July 2016
Results First Received: April 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: ELND005
Drug: Placebo

  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
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Reporting Groups
  Description
ELND005

ELND005 film coated tablets, BID for 12 weeks

ELND005

Placebo

Matched placebo BID for 12 weeks

Placebo


Participant Flow:   Overall Study
    ELND005     Placebo  
STARTED     175     175  
COMPLETED     157     157  
NOT COMPLETED     18     18  
Adverse Event                 8                 7  
Lost to Follow-up                 1                 0  
Physician Decision                 0                 1  
Sponsor Decision                 2                 1  
Withdrawal by Subject                 7                 9  



  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
ELND005

ELND005 film coated tablets, BID for 12 weeks

ELND005

Placebo

Matched placebo BID for 12 weeks

Placebo

Total Total of all reporting groups

Baseline Measures
    ELND005     Placebo     Total  
Number of Participants  
[units: participants]
  175     175     350  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     13     20     33  
>=65 years     162     155     317  
Age  
[units: years]
Mean (Standard Deviation)
  76.2  (7.89)     75.9  (8.51)     76.0  (8.19)  
Gender  
[units: participants]
     
Female     95     100     195  
Male     80     75     155  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     2     1     3  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     17     22     39  
White     155     151     306  
More than one race     0     0     0  
Unknown or Not Reported     1     1     2  
Region of Enrollment  
[units: participants]
     
Canada     7     10     17  
United States     153     152     305  
United Kingdom     2     3     5  
Spain     13     10     23  



  Outcome Measures
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1.  Primary:   Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A).   [ Time Frame: Week 12 ]

2.  Secondary:   Change From Baseline in Modified-ADCS-CGIC Agitation Scores   [ Time Frame: Week 12 ]

3.  Secondary:   Change From Baseline in NPI Total Scores   [ Time Frame: Week 12 ]

4.  Secondary:   Change From Baseline in MMSE Scores   [ Time Frame: Week 12 ]

5.  Secondary:   Change From Baseline in ADCS-ADL Scores   [ Time Frame: Week 12 ]


  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
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  More Information
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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: Aleksandra Pastrak, MD, PhD, Vice President Clinical Development
Organization: Transition Therapeutics Ireland Limited
phone: +1 416 263 1227
e-mail: apastrak@transitiontherapeutics.com



Responsible Party: Transition Therapeutics Ireland Limited
ClinicalTrials.gov Identifier: NCT01735630     History of Changes
Other Study ID Numbers: ELND005-AG201
2012-004299-20 ( EudraCT Number )
Study First Received: November 25, 2012
Results First Received: April 7, 2016
Last Updated: July 6, 2016
Health Authority: United States: Food and Drug Administration