ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
Transition Therapeutics
Information provided by (Responsible Party):
Transition Therapeutics Ireland Limited
ClinicalTrials.gov Identifier:
NCT00934050
First received: June 29, 2009
Last updated: May 12, 2015
Last verified: May 2015
Results First Received: April 22, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Intervention: Drug: ELND005 (scyllo-inositol)

  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
All participants who enrolled in long term follow up prior to 15 Dec 2009 received ELND005 2000 mg BID; due to protocol amendment, all participants who enrolled in long term follow up after 15 Dec 2009 received ELND005 250 mg BID

Reporting Groups
  Description
Placebo/ELND005 2000mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
250mg/ELND005 2000mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mgPO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
1000 mg/ELND005 2000 mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
2000 mg ELND005/ELND005 2000 mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
Placebo/ELND005 250 mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
250 mg/ELND005 250 mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.

Participant Flow for 2 periods

Period 1:   Enrolled Prior to 15 Dec 2009
    Placebo/ELND005 2000mg BID     250mg/ELND005 2000mg BID     1000 mg/ELND005 2000 mg BID     2000 mg ELND005/ELND005 2000 mg BID     Placebo/ELND005 250 mg BID     250 mg/ELND005 250 mg BID  
STARTED     12     12     12     14     0     0  
COMPLETED     0     0     0     0     0     0  
NOT COMPLETED     12     12     12     14     0     0  
Adverse Event                 1                 0                 0                 1                 0                 0  
Sponsor Decision                 11                 12                 11                 13                 0                 0  
Withdrawal by Subject                 0                 0                 1                 0                 0                 0  

Period 2:   Enrolled After 15 Dec 2009
    Placebo/ELND005 2000mg BID     250mg/ELND005 2000mg BID     1000 mg/ELND005 2000 mg BID     2000 mg ELND005/ELND005 2000 mg BID     Placebo/ELND005 250 mg BID     250 mg/ELND005 250 mg BID  
STARTED     0     0     0     0     26     27  
COMPLETED     0     0     0     0     19     23  
NOT COMPLETED     0     0     0     0     7     4  
Adverse Event                 0                 0                 0                 0                 3                 0  
Death                 0                 0                 0                 0                 0                 1  
Lost to Follow-up                 0                 0                 0                 0                 0                 1  
Withdrawal by Subject                 0                 0                 0                 0                 4                 2  



  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/2000mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
250mg BID/2000 mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
1000mg BID/2000mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
2000mg BID/2000mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND05 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
Placebo/ELND005 250mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
250 mg/ELND005 250 mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo/2000mg BID     250mg BID/2000 mg BID     1000mg BID/2000mg BID     2000mg BID/2000mg BID     Placebo/ELND005 250mg BID     250 mg/ELND005 250 mg BID     Total  
Number of Participants  
[units: participants]
  12     12     12     14     26     27     103  
Age  
[units: Years]
Mean (Standard Deviation)
             
Enrolled prior to 15 Dec 2009     76.8  (5.51)     77.0  (6.98)     76.9  (6.92)     69.2  (8.51)     NA  (NA) [1]   NA  (NA) [1]   74.7  (7.73)  
Participants enrolled after 15 Dec 2009     NA  (NA) [2]   NA  (NA) [2]   NA  (NA) [2]   NA  (NA) [2]   71.4  (8.77)     73.0  (7.53)     72.2  (8.12)  
Gender  
[units: participants]
             
Female     5     5     5     7     18     19     59  
Male     7     7     7     7     8     8     44  
Race/Ethnicity, Customized  
[units: participants]
             
Hispanic or Latino     1     0     0     0     0     1     2  
Not Hispanic or Latino     11     12     12     14     26     26     101  
Region of Enrollment  
[units: participants]
             
North America     12     12     12     14     26     27     103  
[1] All participants enrolled after 15 Dec 2009
[2] All participants enrolled prior to 15 Dec 2009



  Outcome Measures

1.  Primary:   Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: 12 months ]


  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
No text entered.


  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: Susan Abushakra, MD, Chief Medical Officer
Organization: Transition Therapeutics Ireland Limited and Transition Therapeutics USA Inc.
phone: +1 650 425 6370
e-mail: susan.abushakra@tthi.us


No publications provided


Responsible Party: Transition Therapeutics Ireland Limited
ClinicalTrials.gov Identifier: NCT00934050     History of Changes
Other Study ID Numbers: ELND005-AD251
Study First Received: June 29, 2009
Results First Received: April 22, 2015
Last Updated: May 12, 2015
Health Authority: United States: Food and Drug Administration