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

This study has been completed.

Sponsor:

Collaborator:

Transition Therapeutics

Information provided by:

Elan Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00934050

First received: June 29, 2009

Last updated: July 13, 2011

Last verified: July 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	June 29, 2009
Last Updated Date	July 13, 2011
Start Date ^ICMJE	June 2009
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Current 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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
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 Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: 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 Arm (s)	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
Estimated Enrollment ^ICMJE	150
Completion Date	June 2011
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.
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT Number ^ICMJE	NCT00934050
Other Study ID Numbers ^ICMJE	ELND005-AD251
Has Data Monitoring Committee	No
Responsible Party	Jesse Cedarbaum, Elan Pharmaceuticals
Study Sponsor ^ICMJE	Elan Pharmaceuticals
Collaborators ^ICMJE	Transition Therapeutics
Investigators ^ICMJE	Not Provided
Information Provided By	Elan Pharmaceuticals
Verification Date	July 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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