For Men and Women who have mild cognitive impairment or mild Alzheimer's disease
About this clinical research study
Cognitive tests are used to check people who are being treated for mild cognitive impairment or mild Alzheimer’s disease. The tests allow researchers to study how a person’s condition has changed after taking medication or over time. Participants in this clinical research study will complete a series of cognitive tests more often than in traditional studies while taking study medication to see if this new testing approach can improve future clinical trials.
Do I qualify for this study?
You may qualify to take part in this study if you are 55-85 years of age and:
• Have mild cognitive impairment or mild Alzheimer’s disease.
• Have not taken medications or other treatments for mild Alzheimer’s disease symptoms in the last six months.
• Have a study partner/caregiver who:
o Is in regular contact with you and knows you well.
o Can attend study visits with you when required.
o Can participate in study assessments that involve caregiver input.
There are additional requirements that must be met in order to participate in this study.
What will happen during this study?
If you qualify and agree to participate, you will be in the study for approximately 15-17 weeks. Study periods include:
• Screening period of approximately 3-5 weeks. This is to see if you qualify for
the study.
• Treatment period of 10 weeks. You will take the study drug during this period and come to the clinic every 2 weeks for cognitive testing.
• A post-study visit. Two weeks after taking your last dose of the study drug, you will visit the study clinic for a final series of assessments.
You will be given a medication diary to record when you take the study drug, which is every evening over 10 weeks. You will bring this diary to your study clinic visits. Your study partner/caregiver is very important. He or she will attend at least one study clinic visit with you and help with the assessments of your mild cognitive impairment or Alzheimer’s disease.
What is the study drug?
The study drug (Donepezil) is approved to treat dementia associated with Alzheimer’s
disease. It will be taken every evening before bedtime during the 10-week treatment period.
Will I receive the study drug?
Participants will be randomly assigned to receive the study drug or a placebo. The placebo looks just like the study drug, but contains no active ingredient. You will have a two out of three chance of receiving the study drug.
What tests and assessments are involved in this study?
Medical tests include a physical exam, neurological exam, vital signs, blood and urine tests. You will also be given cognitive tests and questionnaires regularly to evaluate your attention, memory, mood, and ability to learn new things.
About clinical research
Clinical research studies evaluate how our bodies respond to investigational drugs, devices, and medical assessments to determine whether they are safe and effective. Studies are carefully designed and take place according to strict standards and ethical principles.
Are there risks?
There may be some risks and discomforts associated with the study drug and the medical assessments. The study doctor will go over the potential risks and benefits of this study and answer your questions.
Why participate?
There is no guarantee that your condition will improve while you are in this study. However, by participating, you will help researchers learn more information that could help other people in the future who have mild cognitive impairment or mild Alzheimer’s disease and help future research studies. During the course of the study, if you decide you no longer want to participate, you may stop participating in the study at any time.
Is there a cost to participate?
Participants will receive the study drug and study-related tests at no charge.
To see if you may pre-qualify for the study, call Insight Clinical Trials at (216) 526-1843 or fill out this form.
During the screening visit, you will:
Meet with the study doctor and staff
Review additional information
Have an initial evaluation and undergo tests
Complete study questionnaires
If you qualify and decide to participate:
A study doctor will monitor your symptoms during the study
All study-related medication and medical care will be provided at no cost
Eligible participants may receive reasonable compensation for their time and travel.
Click here to download a patient one-sheet. Free marketing materials are available by calling 216-526-1843.