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| Sponsor: | Medivation, Inc. |
|---|---|
| Collaborator: |
Pfizer |
| Information provided by: | Medivation, Inc. |
| ClinicalTrials.gov Identifier: | NCT00954590 |
Purpose
The purpose of this study is to determine if Dimebon is safe and effective in patients with moderate to severe Alzheimer's disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Moderate to Severe Alzheimer |
Drug: Dimebon (latrepirdine) Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | CONTACT: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Six-Month Safety and Efficacy Study of Dimebon in Patients With Moderate-to-Severe Alzheimer's Disease |
| Arms | Assigned Interventions |
|---|---|
|
Dimebon (latrepirdine): Experimental
Dimebon, 20 mg orally three times daily
|
Drug: Dimebon (latrepirdine)
20 mg orally three times daily
|
|
Placebo: Placebo Comparator
Placebo orally three times daily
|
Drug: Placebo
Placebo orally three times daily
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Medivation, Inc. ( Lynn Seely, MD / Chief Medical Officer ) |
| ClinicalTrials.gov Identifier: | NCT00954590 History of Changes |
| Other Study ID Numbers: | DIM19 |
| Study First Received: | August 6, 2009 |
| Last Updated: | May 14, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
