Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer's Disease on Donepezil (CONCERT)

This study has been completed.

Sponsor:

Collaborator:

Pfizer

Information provided by (Responsible Party):

Medivation, Inc.

ClinicalTrials.gov Identifier:

NCT00829374

First received: January 23, 2009

Last updated: August 27, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 23, 2009
Last Updated Date	August 27, 2012
Start Date ^ICMJE	March 2009
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 1, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: January 23, 2009)	Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: Baseline, Weeks 12, 26, 39 and 52 ] [ Designated as safety issue: No ] Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) [ Time Frame: Baseline, Weeks 13, 26, 39, and 52 ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00829374 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 1, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: January 23, 2009)	Clinician's Interview Based Impression of Change, plus caregiver input (CIBIC-plus) [ Time Frame: Baseline, Weeks 12, 26,39 and 52 ] [ Designated as safety issue: No ] Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, Weeks 13, 26, 39 and 52 ] [ Designated as safety issue: No ] Resource Utilization in Dementia Lite (RUD lite) [ Time Frame: Baseline, Weeks 26 and 52 ] [ Designated as safety issue: No ] Euro Quality of Life 5 (EQ-5D) [ Time Frame: Baseline, Weeks 26 and 52 ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Alzheimer's Disease
Intervention ^ICMJE	Drug: Dimebon 5 mg orally three times daily Drug: Dimebon 20 mg orally three times daily Drug: Placebo comparator Placebo orally three times daily
Study Arm (s)	Experimental: 1 Dimebon, 5 mg orally three times daily Intervention: Drug: Dimebon Experimental: 2 Dimebon, 20 mg orally three times daily Intervention: Drug: Dimebon Placebo Comparator: 3 placebo orally three times daily Intervention: Drug: Placebo comparator
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1003
Completion Date	December 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	50 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Australia, Belgium, Finland, France, Germany, Italy, New Zealand, Sweden, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00829374
Other Study ID Numbers ^ICMJE	DIM18
Has Data Monitoring Committee	Yes
Responsible Party	Medivation, Inc.
Study Sponsor ^ICMJE	Medivation, Inc.
Collaborators ^ICMJE	Pfizer
Investigators ^ICMJE	Not Provided
Information Provided By	Medivation, Inc.
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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