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Byrd Alzheimer’s Center and Research Institute

USF Health Byrd Alzheimer’s Center and Research Institute

Clinical Trials FAQ

Before a new treatment or medication can be prescribed by physicians, it has to be tested thoroughly under supervision of the FDA and other authorities to determine the most effective dosage, the safety (side effects), and other important information that users and doctors should know. This research is done using a clinical trial. Clinical trials usually include a large number of participants with a medical concern or diagnosis who are followed very closely by medical experts while trying the new medication.

People with Alzheimer's disease, those with Mild Cognitive Impairment, or those with a family history of Alzheimer's disease, who want to help scientists test possible treatments may be able to take part in clinical trials. Healthy people also can help researchers learn more about the brain, memory loss and Alzheimer's disease.

With just a small number of FDA approved medications for the treatment of Alzheimer's disease, we recognize the critical need to research new treatment options. Current medications cannot stop Alzheimer's disease. These medications may help prevent some symptoms from getting worse. Current research is aiming to halt the progression of Alzheimer's disease itself or target some of the protein build ups in the brain. Additionally, there is a great need for better ways to diagnosis and treat memory problems earlier.

In order for any new drug to be available in the US, it has to be tested and approved by the FDA for safety and effectiveness. This process often takes years. To get approval, a small group of people try a new medication so researchers can see if it is effective, what dose is optimal, and if there are any side effects.

People with Alzheimer's disease, those with Mild Cognitive Impairment, or those with a family history of Alzheimer's disease, who want to help scientists test possible treatments may be able to take part in clinical trials. Healthy people also can help researchers learn more about the brain, memory loss and Alzheimer's disease.

There are many benefits from participating in a clinical trial. Participants may have the opportunity to try a study medication that is not otherwise available. They receive the benefit of ongoing memory evaluations and follow-up visits that may be more thorough and more frequent than what you might expect from regular doctor visits. They also will be in contact with clinicians who specialize in Alzheimer's disease, so they often have access to more resources and information than others. Our research team understands the concerns of our patients and caregivers and offers support and answers questions as they arise.

All study procedures are paid for by the study sponsor so participants never have to pay anything out of pocket. Depending on the sponsor of a study, participants and study partners may receive compensation for their time and travel while participating in the study.

Not everyone is eligible to participate in a clinical trial. Each study has different eligibility criteria, including age, diagnosis and other medical related conditions. Potential participants need to be in good health, have a diagnosis of mild cognitive impairment or Alzheimer's disease, and be on stable doses of their current medications for a period of time before enrolling. Each participant must also have a "study partner" who can come to study visits with them and help report changes. The study partner can be a friend or family member, but should be someone who has frequent contact with the participant.

If you or your loved one currently sees one of our clinicians, you can ask about clinical trials at your next visit. Otherwise, you can call one of our clinical trial team members and discuss studies that are currently enrolling based on the participant's diagnosis and current cognitive functioning.

Once we find a study you might be interested in, potential participants and their study partners come in for a screening visit. First, we present the informed consent for the study to them. The informed consent is a document that explains the purpose of the study, what is involved in participation, the risks and benefits, and other important details. Then we make sure that a person is eligible for the drug study by performing a number of assessments, including a memory test, physical exam, blood work, and interviews. Some studies may request that you have had a recent CT scan or MRI that supports the diagnosis of Alzheimer's disease. After we collect all the information from these procedures, we can determine whether or not you are eligible to participate in the drug study.

After confirming drug study eligibility, participants return for study visits for the duration of the study period. Frequency of visits depends on the study protocols.

When you come in for study visits, you can expect to meet with the study coordinator and the research staff, receive your study medication, and have a number of assessments done which may include memory testing, participant and study partner interviews, and blood and urine tests. Some studies may also require intermittent MRI or PET scans during the time you are participating.

A placebo is a substance that is made to look exactly like the study medication, but it has no effect on you.  It is used to compare the treated cohort versus those not taking any medication at all. In order to know if a study medication works, we have to compare the study medication to a placebo. All participants are randomly put into either the placebo group or in the group who receives the active study medication. During the study, no one knows who is in which group. All participants, regardless of which group they are in, will still benefit from the ongoing evaluations and physician contacts. Sometimes studies may feature an extension period where all individuals who complete the original study period are given the active medication.

There is a chance that a participant could receive a placebo during the course of a drug study. The chance you may receive a placebo in a study varies. You should take this into consideration when selecting a study to participate in.

Yes. The studies usually require that you have been on a medication for a certain period of time, but generally, all the currently FDA-approved medications are allowed. During the study, you will need to stay on the same medications and take the same dosage for a period leading up to the study and throughout the trial.

There are no known treatments that can completely stop or prevent Alzheimer's disease. However, the FDA-approved drugs donepezil (Aricept ®), rivastigmine (Exelon ®), or galantamine (Razadyne ®, formerly known as Reminyl ®) may help slow down progression of symptoms in all stages. Another drug, memantine (Namenda ®) has been approved to treat moderate to severe Alzheimer's disease, although it also is limited in its benefits. The newest medication, Namzaric, combines donepezil and memantine in one capsule. 

There are other medications that may help control behavioral symptoms of Alzheimer's disease such as sleeplessness, agitation, wandering, anxiety, and depression. Treating these symptoms often makes patients more comfortable and makes their care easier for caregivers. However, none of the medications are approved by the FDA specifically for this purpose.

The National Institute on Aging (NIA), part of the National Institutes of Health (NIH), is the lead Federal agency for Alzheimer's disease research. Additionally, we work with a number of pharmaceutical companies who are also studying new treatments for memory loss or diagnostic procedures. Some of our current and past pharmaceutical sponsors of our research studies include Pfizer, Eisai, Eli Lilly, Merck, Baxter, Janssen, Bayer, Roche, AbbVie, Suven and Novartis.

Many of these studies are being done at NIA-supported Alzheimer's Disease Centers located throughout the United States. These centers carry out a wide range of research, including studies of the causes, diagnosis, treatment, and management of Alzheimer's disease.

The National Institute on Aging (NIA) also supports the Alzheimer's Disease Cooperative Study (ADCS), a consortium of researchers at 109 sites in the U.S. and Canada that conduct large-scale clinical trials of new approaches to treating and preventing Alzheimer's disease. The ADCS is based at the University of California, San Diego and the USF Health Byrd Alzheimer's Institute is a research site for the Alzheimer's Disease Cooperative Study (ADCS).

The NIA maintains the Alzheimer's disease Clinical Trials Database, which lists Alzheimer's disease clinical trials sponsored by the Federal government and private companies. Click here for the NIA clinical trials database.