Alzheimer's DiseasePhase 3CONCERTNCT00829374
Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
A Phase 3 study testing Dimebon in people with Alzheimer's Disease, run by Medivation, Inc. at 101 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Dimebon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,003 participants
- Where
- 101 sitesin 10 countries
- Study dates
- Mar 2009to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Other causes of dementia
- Major structural brain disease
- Unstable medical condition or significant hepatic or renal disease
Trial locations and contacts
101 sites in 10 countries.
101 sites in 10 countries
United States52 sites
Study site
Albany, New York, 12208
Study site
Ann Arbor, Michigan, 48105
Study site
Atlanta, Georgia, 30329
Study site
Austin, Texas, 78757
Study site
Beachwood, Ohio, 44122
Study site
Boston, Massachusetts, 02118
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Boulder, Colorado, 80304
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Cedarhurst, New York, 11516
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Charlottesville, Virginia, 22903
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Costa Mesa, California, 92626
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Deerfield Beach, Florida, 33064
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Delray Beach, Florida, 33445
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Denver, Colorado, 80218
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Durham, North Carolina, 27710
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Eaton, Maryland, 21601
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Encino, California, 91316
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Escondido, California, 92025
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Fresno, California, 93720
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Garden Grove, California, 92845
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Honolulu, Hawaii, 96814
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Houston, Texas, 77030
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Indianapolis, Indiana, 46260
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Jacksonville, Florida, 32224
Study site
Jenkintown, Pennsylvania, 19046
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La Jolla, California, 92037
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Las Vegas, Nevada, 89106
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Lexington, Kentucky, 40536
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Los Alamitos, California, 90720
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Los Angeles, California, 90095
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Martinez, California, 94553
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Miami, Florida, 33137
Study site
Middleton, Wisconsin, 53562
Study site
Mount Arlington, New Jersey, 07865
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New Haven, Connecticut, 06510
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New York, New York, 10029
Study site
Newport, California, 92660
Study site
Norristown, Pennsylvania, 19401
Study site
Orlando, Florida, 32806
Study site
Paramount, California, 90723
Study site
Pasadena, California, 91105
Study site
Phoenix, Arizona, 85006
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Princeton, New Jersey, 08540
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Providence, Rhode Island, 02906
Study site
Rochester, New York, 14620
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92103
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San Francisco, California, 94143
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Seattle, Washington, 98108
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Sun City, Arizona, 85351
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Toledo, Ohio, 43623
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Tucson, Arizona, 85724
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Washington D.C., District of Columbia, 20057
United Kingdom14 sites
Study site
Bath
Study site
Blackpool
Study site
Bradford
Study site
Brentford, Middlesex
Study site
Glasgow, Scotland
Study site
Greater Manchester
Study site
London
Study site
Newcastle upon Tyne
Study site
Norfolk
Study site
Oxford
Study site
Rushden, Northhamptonshire
Study site
Southampton
Study site
Swindon
Study site
Worthington, West Sussex
Australia7 sites
Study site
Adelaide, South Australia
Study site
Brisbane, Queensland
Study site
Geelong, Victoria
Study site
Melbourne, Victoria
Study site
Newcastle, New South Wales
Study site
Perth, Western Australia
Study site
Sydney, New South Wales
France6 sites
Study site
Bordeaux
Study site
Concert
Study site
Lille
Study site
Montpellier
Study site
Nice
Study site
Toulouse
Germany6 sites
Study site
Berlin
Study site
Bochum
Study site
Freiburg im Breisgau
Study site
Hattingen
Study site
Mannheim
Study site
Munich
Italy5 sites
Study site
Brescia
Study site
Florence
Study site
Genoa
Study site
Perugia
Study site
Rome
About this 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
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.
- Conditions
- Alzheimer's Disease
- Being tested
- Dimebon, Placebo comparator
- Keywords
- Alzheimer's disease, clinical trial, mitochondria, memory loss, neurodegenerative disease, dementia, investigational drug
- Medical subject headings
- Alzheimer Disease, Memory Disorders, Neurodegenerative Diseases, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DimebonDrug
5 mg orally three times daily
DimebonDrug
20 mg orally three times daily
Placebo comparatorDrug
Placebo orally three times daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dimebon, 5 mg orally three times daily Receives: Drug: Dimebon |
| 2 | Experimental | Dimebon, 20 mg orally three times daily Receives: Drug: Dimebon |
| 3 | Placebo comparator | Placebo orally three times daily Receives: Drug: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Measured: Week 52
Alzheimer's Disease Assessment Scale - Cognitive Subscale
Measured: Week 52
Secondary outcomes (4)
Clinician's Interview Based Impression of Change, plus caregiver input (CIBIC-plus)
Measured: Week 52
Neuropsychiatric Inventory (NPI)
Measured: Week 52
Resource Utilization in Dementia Lite (RUD lite)
Measured: Week 52
Euro Quality of Life 5 (EQ-5D)
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,003 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medivation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829374
- Sponsor's protocol ID
- DIM18
- Acronym
- CONCERT
- Status last verified
- Sep 2016
- First submitted
- 23 Jan 2009
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00829374
- Acronym / sponsor ID
- CONCERT / DIM18
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, clinical trial, mitochondria, memory loss, neurodegenerative disease, dementia, investigational drug
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,003 participants (actual)
- Lead sponsor
- Medivation, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Mar 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DimebonDimebon, 5 mg orally three times daily |
| 2 | Experimental | Drug: DimebonDimebon, 20 mg orally three times daily |
| 3 | Placebo comparator | Drug: Placebo comparatorPlacebo orally three times daily |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Other causes of dementia
- Major structural brain disease
- Unstable medical condition or significant hepatic or renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dimebon5 mg orally three times daily | Drug | 1 |
| Dimebon20 mg orally three times daily | Drug | 2 |
| Placebo comparatorPlacebo orally three times daily | Drug | 3 |
Primary outcome
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Time frame: Week 52
Alzheimer's Disease Assessment Scale - Cognitive Subscale
Time frame: Week 52
4 secondary outcomes
Clinician's Interview Based Impression of Change, plus caregiver input (CIBIC-plus)
Time frame: Week 52
Neuropsychiatric Inventory (NPI)
Time frame: Week 52
Resource Utilization in Dementia Lite (RUD lite)
Time frame: Week 52
Euro Quality of Life 5 (EQ-5D)
Time frame: Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
101 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dimebon in people with Alzheimer's Disease, run by Medivation, Inc. at 101 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 101 sites in United States, United Kingdom, Australia, France, Germany and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) (time frame: Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016.