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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00954590
First Posted: August 7, 2009
Last Update Posted: September 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Medivation, Inc.
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00954590


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

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT00954590     History of Changes
Other Study ID Numbers: DIM19
First Submitted: August 6, 2009
First Posted: August 7, 2009
Last Update Posted: September 27, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders