CONCERT Dimebon Study
Enrollment — Open
What is the purpose of this study?
The purpose of this study is to assess the effectiveness and safety of Dimebon compared to placebo in mild to moderate Alzheimer's disease patients who are already taking donepezil. Dimebon may help brain cells survive and grow by protecting the mitochondria; dysfunction of the mitochondria is thought to play an important role in neurodegenerative diseases like AD. It may also increase the activity of certain neurotransmitters in the brain that influence cognition and memory that are impaired in people with AD.
What is the design of this study?
Participants will be randomly assigned (by chance) to one of three groups: One of two different doses of Dimebon (5 mg or 20 mg three times daily) or placebo (inactive substance or "sugar pill"). Subjects will have a 2 in 3 chance of receiving Dimebon. Neither the participants nor the research team will know which group a participant has been assigned ("double-blind"). Subjects will receive active drug or placebo capsules, to be taken three times daily for 52 weeks along with a 10 mg tablet of Aricept.
What is involved for individuals who wish to participate?
At an initial screening visit, study staff will obtain consent from the participants, review the medical history and perform a brief memory test, physical and neurologic examination. Then, if the subject meets study criteria, study staff will collect blood and urine samples for lab tests and an EKG. If a brain CT scan or MRI has not been conducted within the past 12 months this will be ordered. If eligible to participate the participant will return in about 30 days for the baseline visit and subsequent visits at week 1, week 2, week 6, week 13, week 26, week 39, week 52 and week 56 (four weeks after the study is concluded) if they do not enroll into an open-label extension study. Further details about each study visits are included in the consent form (there are ten clinic visits during the trial).
Who is eligible to participate?
A person may be eligible to participate if he or she:
- Is male or female ages 50+
- Has a diagnosis of Alzheimer's disease, with a score of 14-24 on the Mini-Mental Status Exam (MMSE)
- Has a reliable caregiver who is with them for at least three hours a day/five days a week and can provide reliable information for caregiver questionnaires
- Have been taking donepezil (Aricept®) with stable dosing at 10 mg/day for at least four months prior to day 1 or beginning study medication.
Can participants in this study continue taking their regular medications?
Yes. Aricept® must be taken (ONLY 10 mg daily). Other anti-dementia medications such as Razadyne, Namenda, Exelon are not allowed in the study. There is a list of allowable drugs that may be used during the study that include medication used to control acceptable chronic medical conditions or drugs used on an as needed basis. The study doctor will let you know what other medications are not allowed in this study.
Are there any risks associated with this study?
Dimebon is an investigational drug and all of the possible side effects are not fully known. The drug has been previously studied in people with AD and has been generally well tolerated in clinical trials to date.
Where is this study being held?
Baylor College of Medicine is one of about 100 sites participating in this trial, which will be conducted internationally.
For more information
Contact: Aline Hittle at Baylor College of Medicine