Clinical trial NCT00829374: Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
clinical trial
mitochondria
memory loss
neurodegenerative disease
dementia
investigational drug
Lead sponsor: Medivation, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2009-01-27
Enrollment: 1003
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Mild-to-moderate Alzheimer's disease (AD)
* Probable AD (Diagnostic Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR))
* Mini-Mental State Examination (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

Primary outcomes:
measure: Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
timeFrame: Week 52
measure: Alzheimer's Disease Assessment Scale - Cognitive Subscale
timeFrame: Week 52
Secondary outcomes:
measure: Clinician's Interview Based Impression of Change, plus caregiver input (CIBIC-plus)
timeFrame: Week 52
measure: Neuropsychiatric Inventory (NPI)
timeFrame: Week 52
measure: Resource Utilization in Dementia Lite (RUD lite)
timeFrame: Week 52
measure: Euro Quality of Life 5 (EQ-5D)
timeFrame: Week 52
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Sun City
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Costa Mesa
country: United States
state: California
city: Encino
country: United States
state: California
city: Escondido
country: United States
state: California
city: Fresno
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Los Alamitos
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Martinez
country: United States
state: California
city: Newport
country: United States
state: California
city: Paramount
country: United States
state: California
city: Pasadena
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Boulder
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Deerfield Beach
country: United States
state: Florida
city: Delray Beach
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Indianapolis
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Eaton
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Las Vegas
country: United States
state: Nevada
city: Mt Arlington
country: United States
state: New Jersey
city: Princeton
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Cedarhurst
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Beachwood
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Jenkintown
country: United States
state: Pennsylvania
city: Norristown
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Middleton
country: United States
state: Wisconsin
city: Newcastle
country: Australia
state: New South Wales
city: Sydney
country: Australia
state: New South Wales
city: Brisbane
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: Geelong
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Perth
country: Australia
state: Western Australia
city: Antwerp
country: Belgium
city: Leuven
country: Belgium
city: Sint-Truiden
country: Belgium
city: Kuppio
country: Finland
city: Oulu
country: Finland
city: Turku
country: Finland
city: Bordeaux
country: France
city: Concert
country: France
city: Lille
country: France
city: Montpellier
country: France
city: Nice
country: France
city: Toulouse
country: France
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Freiburg
country: Germany
city: Hattingen
country: Germany
city: Mannheim
country: Germany
city: Munich
country: Germany
city: Brescia
country: Italy
city: Florence
country: Italy
city: Genoa
country: Italy
city: Perugia
country: Italy
city: Rome
country: Italy
city: Christchurch
country: New Zealand
state: Canterbury
city: Auckland
country: New Zealand
city: Malmo
country: Sweden
city: Norrkoping
country: Sweden
city: Stockholm
country: Sweden
city: Brentford
country: United Kingdom
state: Middlesex
city: Rushden
country: United Kingdom
state: Northhamptonshire
city: Glasgow
country: United Kingdom
state: Scotland
city: Worthington
country: United Kingdom
state: West Sussex
city: Bath
country: United Kingdom
city: Blackpool
country: United Kingdom
city: Bradford
country: United Kingdom
city: Greater Manchester
country: United Kingdom
city: London
country: United Kingdom
city: Newcastle upon Tyne
country: United Kingdom
city: Norfolk
country: United Kingdom
city: Oxford
country: United Kingdom
city: Southampton
country: United Kingdom
city: Swindon
country: United Kingdom
Study officials:
References: