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

History of Changes

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:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

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 (Adult, Senior)
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


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 Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases	Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders

ClinicalTrials.gov processed this record on September 23, 2016

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