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| Descriptive Information Fields | |
| Brief Title † | ELND005 in Patients With Mild to Moderate Alzheimer's Disease |
| Official Title † | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Safety and Efficacy Study of Oral ELND005 (AZD-103) in Alzheimer's Disease |
| Brief Summary | 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. |
| Detailed Description | 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. |
| Study Phase | Phase II |
| Study Type † | Interventional |
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Primary Outcome Measure † | Safety and Tolerability; Cognitive and Functional Measures [ Time Frame: 18 months ] [ Designated as safety issue: No ] |
| Secondary Outcome Measure † | |
| Condition † | Alzheimer Disease |
| Intervention † | Drug: ELND005 Drug: Placebo Control |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Active, not recruiting |
| Enrollment † | 340 |
| Start Date † | December 2007 |
| Completion Date | May 2010 |
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 50 Years to 85 Years |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States, Canada |
| Administrative Information Fields | |
| NCT ID † | NCT00568776 |
| Organization ID | ELND005-AD201 |
| Secondary IDs †† | |
| Study Sponsor † | Elan Pharmaceuticals |
| Collaborators †† | Transition Therapeutics |
| Investigators † | |
| Information Provided By | Elan Pharmaceuticals |
| Verification Date | October 2008 |
| First Received Date † | December 4, 2007 |
| Last Updated Date | October 29, 2008 |