Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease

This study has been terminated.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Transition Therapeutics Ireland Limited
ClinicalTrials.gov Identifier:
NCT01766336
First received: January 8, 2013
Last updated: May 17, 2016
Last verified: May 2016
Results First Received: April 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: Group 1 ELND005
Drug: Group 2 ELND005

  Participant Flow
  Hide 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
No text entered.

Reporting Groups
  Description
ELND005/ELND005 Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
Placebo/ELND005 Patients who received Placebo in AG201 and received ELND005 in this extension study AG251

Participant Flow:   Overall Study
    ELND005/ELND005   Placebo/ELND005
STARTED   150   146 
COMPLETED   60   71 
NOT COMPLETED   90   75 
Adverse Event                11                8 
Death                4                3 
Lost to Follow-up                1                3 
Physician Decision                4                2 
Protocol Violation                0                1 
Sponsor Decision                52                43 
Withdrawal by Subject                18                15 



  Baseline Characteristics
  Hide 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.
No text entered.

Reporting Groups
  Description
ELND005/ELND005 Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
Placebo/ELND005 Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
Total Total of all reporting groups

Baseline Measures
   ELND005/ELND005   Placebo/ELND005   Total 
Overall Participants Analyzed 
[Units: Participants]
 150   146   296 
Age 
[Units: Years]
Mean (Standard Deviation)
 76.6  (7.9)   75.9  (8.7)   76.2  (8.3) 
Gender 
[Units: Participants]
     
Female   84   81   165 
Male   66   65   131 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   1   1   2 
Black or African American   10   17   27 
White   138   127   265 
Other   1   1   2 
Region of Enrollment 
[Units: Participants]
     
North America   137   134   271 
Europe   13   12   25 


  Outcome Measures

1.  Primary:   Number of Participants Experiencing Treatment Emergent Adverse Events   [ Time Frame: 36 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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 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.
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: Aleksandar 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: NCT01766336     History of Changes
Other Study ID Numbers: ELND005-AG251
2012-005524-15 ( EudraCT Number )
Study First Received: January 8, 2013
Results First Received: April 7, 2016
Last Updated: May 17, 2016
Health Authority: United States: Food and Drug Administration