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

This study has been terminated.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT00954590
First received: August 6, 2009
Last updated: August 27, 2012
Last verified: August 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

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
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 ClinicalTrials.gov identifier: NCT00954590

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

No publications provided

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT00954590     History of Changes
Other Study ID Numbers: DIM19
Study First Received: August 6, 2009
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014