An Extension of the CONCERT Protocol (DIM18) (CONCERT PLUS)

This study has been terminated.

Sponsor:

Collaborator:

Pfizer

Information provided by (Responsible Party):

Medivation, Inc.

ClinicalTrials.gov Identifier:

NCT01152216

First received: June 25, 2010

Last updated: August 27, 2012

Last verified: August 2012

History of Changes

Purpose

An open-label extension study of the CONCERT (DIM18) protocol evaluating the safety of dimebon (latrepirdine) in subjects with With Mild-to-Moderate Alzheimer's Disease on Donepezil.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: Dimebon	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label Extension of the CONCERT Protocol (DIM18) Evaluating Dimebon (Latrepirdine) in Patients With Alzheimer's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:

Safety [ Time Frame: Through study discontinuation ] [ Designated as safety issue: No ]
To evaluate the long-term safety and tolerability of dimebon (latrepirdine) in Alzheimer's disease (AD) patients who have completed 52 weeks of blinded treatment in the DIM18 (CONCERT) protocol.

Enrollment:	672
Study Start Date:	April 2010
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dimebon	Drug: Dimebon 20 mg 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:

Successful completion of the 12 month DIM18 CONCERT study
Mild-to-moderate Alzheimer's disease
Probable AD (DSM-IV-TR)
MMSE score between 12 and 24, 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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Medivation, Inc.
ClinicalTrials.gov Identifier:	NCT01152216 History of Changes
Other Study ID Numbers:	DIM18EXT
Study First Received:	June 25, 2010
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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013

To Top