Alzheimer's DiseasePhase 2NCT00704782
Study of Combination Therapy With Dimebon and Donepezil (Aricept) in Patients With Alzheimer's Disease
A Phase 2 study testing dimebon in people with Alzheimer's Disease, run by Medivation, Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of Dimebon in combination with donepezil (Aricept) in the treatment of Alzheimer's disease. 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?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2008to Aug 2010
- Phase
- Phase 2
- 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
- Alzheimer's disease
- On donepezil (Aricept)
- Caregiver who cares for the patient at least 5 days per week
Who cannot join
- Unstable medical illnesses or significant hepatic or renal disease
- Other primary psychiatric or neurological disorders
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Xenoscience, Inc.
Phoenix, Arizona, 85004
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
Barrow Neurological Institute
Phoenix, Arizona, 85013
Sun Health Research Institute
Sun City, Arizona, 85351
About this study
Official title: An Open-Label Extension Study of Combination Therapy With Dimebon and Donepezil in Patients With Alzheimer's Disease
The purpose of this study is to assess the safety and efficacy of Dimebon in combination with donepezil (Aricept) in the treatment of Alzheimer's disease.
- Conditions
- Alzheimer's Disease
- Being tested
- dimebon
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dimebonDrug
| Study group | Role | What they receive |
|---|---|---|
| Dimebon | Experimental | 20 mg by mouth 3 times a day Receives: Drug: dimebon |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of Dimebon in combination with donepezil (Aricept)
Measured: week 6, 9, 12, 26 and every 13 weeks thereafter until study discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: The study was halted after a Phase 3 study of dimebon failed to show efficacy.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medivation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704782
- Sponsor's protocol ID
- DIM13
- Status last verified
- Nov 2015
- First submitted
- 23 Jun 2008
- Last updated
- 10 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Study of Combination Therapy With Dimebon and Donepezil in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00704782
- Acronym / sponsor ID
- DIM13
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was halted after a Phase 3 study of dimebon failed to show efficacy.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medivation, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 25 Jun 2008 (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 assess the safety and efficacy of Dimebon in combination with donepezil (Aricept) in the treatment of Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dimebon | Experimental | Drug: dimebon20 mg by mouth 3 times a day |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Alzheimer's disease
- On donepezil (Aricept)
- Caregiver who cares for the patient at least 5 days per week
Key exclusion criteria (2 listed)
- Unstable medical illnesses or significant hepatic or renal disease
- Other primary psychiatric or neurological disorders
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 |
|---|---|---|
| dimebon | Drug | Dimebon |
Primary outcome
To assess the safety of Dimebon in combination with donepezil (Aricept)
Time frame: week 6, 9, 12, 26 and every 13 weeks thereafter until study discontinuation
Results and safety
The study was stopped early (reason given: The study was halted after a Phase 3 study of dimebon failed to show efficacy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dimebon in people with Alzheimer's Disease, run by Medivation, Inc. at 4 sites in United States.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: The study was halted after a Phase 3 study of dimebon failed to show efficacy.). Results are not available in the source record.
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?
To assess the safety of Dimebon in combination with donepezil (Aricept) (time frame: week 6, 9, 12, 26 and every 13 weeks thereafter until study discontinuation). 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 10 Dec 2015.