Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00829374




Registration number
NCT00829374
Ethics application status
Date submitted
23/01/2009
Date registered
27/01/2009
Date last updated
27/09/2016

Titles & IDs
Public title
Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
Scientific 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
Secondary ID [1] 0 0
DIM18
Universal Trial Number (UTN)
Trial acronym
CONCERT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dimebon
Treatment: Drugs - Dimebon
Treatment: Drugs - Placebo comparator

Experimental: 1 - Dimebon, 5 mg orally three times daily

Experimental: 2 - Dimebon, 20 mg orally three times daily

Placebo Comparator: 3 - Placebo orally three times daily


Treatment: Drugs: Dimebon
5 mg orally three times daily

Treatment: Drugs: Dimebon
20 mg orally three times daily

Treatment: Drugs: Placebo comparator
Placebo orally three times daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Timepoint [1] 0 0
Week 52
Primary outcome [2] 0 0
Alzheimer's Disease Assessment Scale - Cognitive Subscale
Timepoint [2] 0 0
Week 52
Secondary outcome [1] 0 0
Clinician's Interview Based Impression of Change, plus caregiver input (CIBIC-plus)
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Neuropsychiatric Inventory (NPI)
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Resource Utilization in Dementia Lite (RUD lite)
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Euro Quality of Life 5 (EQ-5D)
Timepoint [4] 0 0
Week 52

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Other causes of dementia

- Major structural brain disease

- Unstable medical condition or significant hepatic or renal disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2011
Sample size
Target
Accrual to date
Final
1003
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
- Newcastle
Recruitment hospital [2] 0 0
- Sydney
Recruitment hospital [3] 0 0
- Brisbane
Recruitment hospital [4] 0 0
- Adelaide
Recruitment hospital [5] 0 0
- Geelong
Recruitment hospital [6] 0 0
- Melbourne
Recruitment hospital [7] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
- Newcastle
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
- Adelaide
Recruitment postcode(s) [5] 0 0
- Geelong
Recruitment postcode(s) [6] 0 0
- Melbourne
Recruitment postcode(s) [7] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Hawaii
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Rhode Island
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Belgium
State/province [25] 0 0
Antwerp
Country [26] 0 0
Belgium
State/province [26] 0 0
Leuven
Country [27] 0 0
Belgium
State/province [27] 0 0
Sint-Truiden
Country [28] 0 0
Finland
State/province [28] 0 0
Kuppio
Country [29] 0 0
Finland
State/province [29] 0 0
Oulu
Country [30] 0 0
Finland
State/province [30] 0 0
Turku
Country [31] 0 0
France
State/province [31] 0 0
Bordeaux
Country [32] 0 0
France
State/province [32] 0 0
Concert
Country [33] 0 0
France
State/province [33] 0 0
Lille
Country [34] 0 0
France
State/province [34] 0 0
Montpellier
Country [35] 0 0
France
State/province [35] 0 0
Nice
Country [36] 0 0
France
State/province [36] 0 0
Toulouse
Country [37] 0 0
Germany
State/province [37] 0 0
Berlin
Country [38] 0 0
Germany
State/province [38] 0 0
Bochum
Country [39] 0 0
Germany
State/province [39] 0 0
Freiburg
Country [40] 0 0
Germany
State/province [40] 0 0
Hattingen
Country [41] 0 0
Germany
State/province [41] 0 0
Mannheim
Country [42] 0 0
Germany
State/province [42] 0 0
Munich
Country [43] 0 0
Italy
State/province [43] 0 0
Brescia
Country [44] 0 0
Italy
State/province [44] 0 0
Florence
Country [45] 0 0
Italy
State/province [45] 0 0
Genoa
Country [46] 0 0
Italy
State/province [46] 0 0
Perugia
Country [47] 0 0
Italy
State/province [47] 0 0
Rome
Country [48] 0 0
New Zealand
State/province [48] 0 0
Canterbury
Country [49] 0 0
New Zealand
State/province [49] 0 0
Auckland
Country [50] 0 0
Sweden
State/province [50] 0 0
Malmo
Country [51] 0 0
Sweden
State/province [51] 0 0
Norrkoping
Country [52] 0 0
Sweden
State/province [52] 0 0
Stockholm
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Middlesex
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Northhamptonshire
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Scotland
Country [56] 0 0
United Kingdom
State/province [56] 0 0
West Sussex
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Bath
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Blackpool
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Bradford
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Greater Manchester
Country [61] 0 0
United Kingdom
State/province [61] 0 0
London
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Newcastle upon Tyne
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Norfolk
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Oxford
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Southampton
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Swindon

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medivation, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00829374
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00829374