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A Safety and Efficacy Study Evaluating Dimebon (Latrepirdine) in Patients With Moderate to Severe Alzheimer's Disease (CONTACT)

This study has been terminated.
Information provided by (Responsible Party):
Medivation, Inc. Identifier:
First received: August 6, 2009
Last updated: September 24, 2016
Last verified: September 2016
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
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

Resource links provided by NLM:

Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • Neuropsychiatric Inventory (NPI) [ Time Frame: 26 weeks post baseline ]
    To evaluate the efficacy of dimebon (latrepirdine) as compared to placebo on a measure of behavior, the Neuropsychiatric Inventory (NPI)

  • Activities of Daily Living (severe) (ADCS ADLsev) [ Time Frame: 26 weeks post baseline ]
    To evaluate the efficacy of dimebon as compared to placebo on a measure of self-care and daily function, the Alzheimer's Disease Cooperative Study - Activities of Daily Living (severe) (ADCS ADLsev).

Enrollment: 89
Study Start Date: October 2009
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dimebon (latrepirdine)
Dimebon, 20 mg orally three times daily
Drug: Dimebon (latrepirdine)
20 mg orally three times daily
Placebo Comparator: Placebo
Placebo orally three times daily
Drug: Placebo
Placebo orally three times daily


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Moderate-to-Severe Alzheimer's disease
  • Mini-Mental State Examination (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00954590

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

Responsible Party: Medivation, Inc. Identifier: NCT00954590     History of Changes
Other Study ID Numbers: DIM19
Study First Received: August 6, 2009
Last Updated: September 24, 2016

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders processed this record on May 25, 2017