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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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Arizona
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California
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Colorado
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Connecticut
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District of Columbia
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Florida
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Georgia
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Hawaii
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Indiana
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Kentucky
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Maryland
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Massachusetts
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Michigan
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Nevada
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Antwerp
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Leuven
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Sint-Truiden
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Kuppio
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Finland
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Oulu
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Finland
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Turku
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France
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Bordeaux
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France
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Concert
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France
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Lille
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France
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Germany
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Bochum
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Germany
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Freiburg
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Germany
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Hattingen
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Germany
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Mannheim
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Germany
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Munich
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Brescia
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Italy
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Florence
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Italy
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Genoa
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Italy
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Perugia
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Italy
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Rome
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New Zealand
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Canterbury
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New Zealand
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Auckland
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Sweden
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Malmo
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Sweden
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Norrkoping
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Sweden
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Stockholm
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United Kingdom
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Middlesex
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Northhamptonshire
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Bath
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Blackpool
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Norfolk
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Oxford
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Southampton
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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00829374