Will I be paid?
Volunteers are not paid for taking part in this Alzheimer’s research. However, the sponsor will reimburse reasonable travel expenses for you and your study partner for each visit.
What is a study partner and why do I need one?
A study partner is someone who accompanies the participant to some study visits and can answer questions about the volunteer’s symptoms. The study partner should be someone who sees the volunteer regularly (e.g., a spouse, relative or close friend) as they will need to inform us about any potential changes in the volunteer’s health or behavior. The number of visits he or she needs to attend depends on each study.
How often are the visits?
This depends on the research study. The screening portion of the study is generally when the visits are most frequent. This is when all initial screening is conducted to confirm whether a volunteer is eligible for a study. During the treatment stage of the study, the visits will be less frequent. Some studies require a clinic visit once a month; other studies require a visit every six weeks. If you enroll in a study, we will be able to give you all of your appointments in advance.
Can I take part if I have vascular dementia?
Unfortunately all of the current studies are for Alzheimer’s disease. However, we are always activating new Alzheimer’s research studies, so please make sure to connect with our team using the contact form so we can keep you updated.
Will I have to take a trial drug?
Yes. If you are eligible for one of the clinical trials, you will consent to be assigned to a treatment group. Depending on the trial, the trial medication may be in the form of a tablet taken orally once a day or an intravenous infusion once a month.
Will I know what I am taking?
No. You will not know whether you are taking the active study drug or a placebo. A placebo is a similar looking tablet, but doesn’t contain any active drug. You will be randomly assigned to a study groups and you and your study team will not know which group you are in. This is called a randomized, double-blind, placebo-controlled trial.
What if I am in the placebo group?
There is a chance you will be in the placebo group. The probability will depend on the trial and will range from a 50% to a 30% placebo group. Whichever group you are in, you will still benefit from the ongoing medical care and psychometric testing you will receive as part of the trial. At the end of the trial period, most trials offer the opportunity for you to enter the “open label extension”. This is when you continue in the trial on the active drug despite whichever group (placebo or active drug) you were in previously. The open label extension is un-blinded, so you will know you are on the active drug.
Are there any side effects?
Any potential side effects will be listed in the patient information sheets sent to you prior to your initial consultation. Most side effects are non-specific, but some trials have specific side effects that your study doctor will discuss with you. If you have a primary care physician, we will work closely with him or her – and you – to ensure your safety at all times.
Can I leave a trial before it concludes?
Absolutely. Leaving a study does not affect your medical or legal rights. And it is not necessary to give us a reason as to why you want to leave, although we always value any feedback. If you choose to leave after you have started taking the study drug, we are obligated to offer you a closing visit to carry out final medical investigations to ensure your safety.
Why are clinical trials important?
Every FDA approved medication you’ve ever taken has gone through a clinical trial and safety is always the #1 priority.
People participate for different reasons.
1. Free medical care
2. Access to medical professionals
3. To learn more about their disease
4. Receive regular updates about the research while they’re enrolled
5. Receive information about the study results after the study has ended
6. To feel part of a community
Participant health is the MOST important to the medical professionals who conduct clinical trials.
Clinical trials have a regulatory and ethical framework to protect participants.
Clinical Trials are one of the most regulated industries. Similar to that of aviation and finance.
The risks and benefits are different for everyone.
Speaking to a study specialist can help to determine if you may be a candidate
All clinical trials have rules about who can and cannot participate
Participants can drop out of clinical trials any time.
Participation involves NO cost and may involve payment.
Clinical trials take place in different settings.
Universities, Hospitals, Physicians Office, or a Private Clinical Trial Centers. Regardless of where you go, the clinical trial protocol will be EXACTLY the same
The majority of clinical trial participants would do it again.
A recent Nationwide survey of clinical trial participants showed that 98% of participants would do it again and 92% felt the experience met or exceeded their expectations