Trial Information
Summary: A Placebo-controlled study to determine the safety and efficacy of Oral Dimebon in Patients with mild to moderate Alzheimer's disease.
We are conducting a study to determine if treatment with Oral Dimebon in patients with Mild-to-Moderate Alzheimer's Disease see an improvement in their symptoms. Dimebon has not yet been approved by the FDA. This is a Placebo controlled study - each subject will have a 1:3 chance of receiveing placebo (2 out of 3 will receive study drug). Subjects will be asked to participate in the study for 6 months and to come to the clinic for a total of 7 visits during that time. Each visit will take aproximately 2-3 hours.
Patient Inclusion Criteria
- Males or females >/= 50 years of age with a diagnosis of Alzheimer's Disease
- Subjects must have a caregiver who will be able to come to all study visits with them.
Patient Exclusion Criteria
- Currently taking medication for Alzheimer's Disease
- Does not have a caregiver who can accompany the subject to the site for study visits
Primary Outcomes
To determine the benefit of Dimebon as compared to placebo on the primary measure of cognition and memory, the Alzheimer's Disease Assessment Scale; and to determine the benefit of Dimebon as compared to Placebo on the primary measure of global function, plus caregiver input.
Key Secondary Outcomes
To determine the benefit of Dimebon on Activities of Daily Living, to determine the safety of treatment with Dimebon as compared to Placebo
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Contact:
Jodi Larkin, Clinical Research Coordinator
Neurocare, Inc.
70 Wells Avenue, Suite 101
Newton, MA 02459
Telephone: 1-800-958-1218
Fax: 617-796-9099
Email:
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Trial listings updated: September 3, 2008 at 2:53:46 PM