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

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ClinicalTrials.gov Identifier: NCT00954590
Recruitment Status : Terminated
First Posted : August 7, 2009
Last Update Posted : September 27, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Medivation, Inc.

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to determine if Dimebon is safe and effective in patients with moderate to severe Alzheimer's disease.

Condition or disease Intervention/treatment Phase
Moderate to Severe Alzheimer Drug: Dimebon (latrepirdine) Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
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
Study Start Date : October 2009
Actual Primary Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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)

  2. 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).


Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT00954590     History of Changes
Other Study ID Numbers: DIM19
First Posted: August 7, 2009    Key Record Dates
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