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Sponsors and Collaborators: |
Elan Pharmaceuticals Transition Therapeutics |
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Information provided by: | Elan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00568776 |
The purpose of this study is to evaluate the dose-related safety and efficacy of multiple oral dosages of ELND005 as treatment for Alzheimer's disease.
Condition | Intervention | Phase |
---|---|---|
Alzheimer Disease |
Drug: ELND005 Drug: Placebo Control |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Safety and Efficacy Study of Oral ELND005 (AZD-103) in Alzheimer's Disease |
Estimated Enrollment: | 340 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator | Drug: ELND005 |
2: Active Comparator | Drug: ELND005 |
3: Active Comparator | Drug: ELND005 |
4: Placebo Comparator | Drug: Placebo Control |
ELND005 (formerly known as AZD-103), scyllo-inositol, is being investigated as an orally administered treatment for Alzheimer's disease (AD). ELND005 may prevent or inhibit the build up of amyloid protein in the brains of Alzheimer's disease patients.
This is a randomized, double-blind, placebo-controlled, dose-ranging, safety and efficacy study of oral ELND005 in male and female participants aged 50-85 years with mild to moderate AD. Approximately 340 patients will be enrolled into the study at approximately 65 study sites. Patients will be randomized to receive either ELND005 or placebo. Each patient's participation will last approximately 18 months.
Ages Eligible for Study: | 50 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Elan Pharmaceuticals ( Jesse Cedarbaum ) |
Study ID Numbers: | ELND005-AD201 |
Study First Received: | December 4, 2007 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00568776 |
Health Authority: | United States: Food and Drug Administration |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Inositol Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
Vitamin B Complex Growth Substances Vitamins Physiological Effects of Drugs |
Nervous System Diseases Micronutrients Tauopathies Pharmacologic Actions |