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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00934050
First Posted: July 8, 2009
Last Update Posted: May 13, 2015
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.
Collaborator:
Transition Therapeutics
Information provided by (Responsible Party):
Transition Therapeutics Ireland Limited
June 29, 2009
July 8, 2009
April 22, 2015
May 13, 2015
May 13, 2015
June 2009
June 2011   (Final data collection date for primary outcome measure)
Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 12 months ]
Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)
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 ]
Complete list of historical versions of study NCT00934050 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease
A Long-Term Follow-Up Study of Oral ELND005 (AZD-103) in Subjects With Alzheimer's Disease
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Alzheimer's Disease
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
Experimental: ELND005
Intervention: Drug: ELND005 (scyllo-inositol)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
June 2011
June 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00934050
ELND005-AD251
No
Not Provided
Not Provided
Transition Therapeutics Ireland Limited
Transition Therapeutics Ireland Limited
Transition Therapeutics
Not Provided
Transition Therapeutics Ireland Limited
May 2015

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