Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer's Disease on Donepezil - Full Text View

Sponsor:	Medivation, Inc.
Collaborator:	Pfizer
Information provided by:	Medivation, Inc.
ClinicalTrials.gov Identifier:	NCT00829374

Purpose

The purpose of this study is to determine if Dimebon is safe and effective in patients with mild to moderate Alzheimer's disease on Donepezil.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: Dimebon Drug: Placebo comparator	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	CONCERT: A Phase 3 Multicenter, Randomized, Placebo-Controlled, Double-Blind Twelve-Month Safety and Efficacy Study Evaluating Dimebon in Patients With Mild-to-Moderate Alzheimer's Disease on Donepezil

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

Drug Information available for: E 2020 Donepezil Dimebolin

U.S. FDA Resources

Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:

Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Alzheimer's Disease Assessment Scale - Cognitive Subscale [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinician's Interview Based Impression of Change, plus caregiver input (CIBIC-plus) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Neuropsychiatric Inventory (NPI) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Resource Utilization in Dementia Lite (RUD lite) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Euro Quality of Life 5 (EQ-5D) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Estimated Enrollment:	1050
Study Start Date:	March 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Dimebon, 5 mg orally three times daily	Drug: Dimebon 5 mg orally three times daily
Experimental: 2 Dimebon, 20 mg orally three times daily	Drug: Dimebon 20 mg orally three times daily
Placebo Comparator: 3 placebo orally three times daily	Drug: Placebo comparator 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:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829374

Show 101 Study Locations

Sponsors and Collaborators

Medivation, Inc.

Pfizer

More Information

No publications provided

Responsible Party:	Andria Langenberg, MD / Vice President, Clinical Development, Medivation, Inc.
ClinicalTrials.gov Identifier:	NCT00829374 History of Changes
Other Study ID Numbers:	DIM18
Study First Received:	January 23, 2009
Last Updated:	March 11, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medivation, Inc.:

Alzheimer's disease
clinical trial
mitochondria
memory loss

neurodegenerative disease
dementia
investigational drug

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
Donepezil

Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012