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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00934050
Recruitment Status : Completed
First Posted : July 8, 2009
Results First Posted : May 13, 2015
Last Update Posted : May 13, 2015
Sponsor:
Collaborator:
Transition Therapeutics
Information provided by (Responsible Party):
Transition Therapeutics Ireland Limited

Tracking Information
First Submitted Date  ICMJE June 29, 2009
First Posted Date  ICMJE July 8, 2009
Results First Submitted Date  ICMJE April 22, 2015
Results First Posted Date  ICMJE May 13, 2015
Last Update Posted Date May 13, 2015
Study Start Date  ICMJE June 2009
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2015)
Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 12 months ]
Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)
Original Primary Outcome Measures  ICMJE
 (submitted: July 6, 2009)
Safety and tolerability analyses will be based on the frequency and severity of adverse events and on clinically important changes in laboratory assessment results. [ Time Frame: 12 months ]
Change History Complete list of historical versions of study NCT00934050 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease
Official Title  ICMJE A Long-Term Follow-Up Study of Oral ELND005 (AZD-103) in Subjects With Alzheimer's Disease
Brief Summary The purpose of this study is to evaluate the long-term safety and tolerability of ELND005 beyond the 18 months of treatment in original randomized and blinded clinical trail ELND005-AD201.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE Drug: ELND005 (scyllo-inositol)

Prior to 15Dec2009: ELND005 2000 mg PO BID for 48 weeks

After 15Dec2009: ELND005 250 mg PO BID for 48 weeks

Other Name: scyllo-inositol
Study Arms  ICMJE Experimental: ELND005
Intervention: Drug: ELND005 (scyllo-inositol)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2014)
103
Original Estimated Enrollment  ICMJE
 (submitted: July 6, 2009)
180
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • This study is open only to subjects who have completed the week 78 visit in Study ELND005-AD201 while taking their assigned dose of study drug medication.

Exclusion Criteria:

  • Subject has no new medical contraindications to continued participation in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00934050
Other Study ID Numbers  ICMJE ELND005-AD251
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Transition Therapeutics Ireland Limited
Study Sponsor  ICMJE Transition Therapeutics Ireland Limited
Collaborators  ICMJE Transition Therapeutics
Investigators  ICMJE Not Provided
PRS Account Transition Therapeutics Ireland Limited
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP