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:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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: Donepezil Dimebolin

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

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

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

Contacts

Contact: Anthony Golsorkhi, MD	415-829-4196	anthony.golsorkhi@medivation.com
Contact: Stewart Hallett, MBA	415-829-4113	stewart.hallett@medivation.com

Sponsors and Collaborators

Medivation, Inc.

Pfizer

More Information

No publications provided

Responsible Party:	Medivation, Inc. ( Andria Langenberg, MD / Vice President, Clinical Development )
Study ID Numbers:	DIM18
Study First Received:	January 23, 2009
Last Updated:	August 12, 2009
ClinicalTrials.gov Identifier:	NCT00829374 History of Changes
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:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on November 22, 2009