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A Safety and Efficacy Study Evaluating Dimebon (Latrepirdine) in Patients With Moderate to Severe Alzheimer's Disease (CONTACT)
This study is currently recruiting participants.
Verified by Medivation, Inc., October 2009
First Received: August 6, 2009   Last Updated: October 26, 2009   History of Changes
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: 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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Disease
Drug Information available for: Dimebolin
U.S. FDA Resources

Further study details as provided by Medivation, Inc.:

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
Criteria

Inclusion Criteria:

  • Moderate-to-Severe Alzheimer's disease
  • MMSE Score between 5 to 14, inclusive
  • Stable on donepezil for at least 6 months

Exclusion Criteria:

  • Other causes of dementia
  • Major structural brain disease
  • Unstable medical condition or significant hepatic or renal disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954590

Contacts
Contact: Fong Wang, MD 415-543-3470 fong.wang@medivation.com

Locations
Chile
Recruiting
Santiago, Chile
United Kingdom, Scotland
Recruiting
Glasgow, Scotland, United Kingdom
Sponsors and Collaborators
Medivation, Inc.
Pfizer
  More Information

No publications provided

Responsible Party: Medivation, Inc. ( Lynn Seely, MD / Chief Medical Officer )
Study ID Numbers: DIM19
Study First Received: August 6, 2009
Last Updated: October 26, 2009
ClinicalTrials.gov Identifier: NCT00954590     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Nervous System Diseases
Central Nervous System Diseases
 Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on February 04, 2010



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