Considering Enrolling in a Dementia Clinical Trial? 6 Things You Should Know

By | July 9th, 2024

Clinical research helps scientists learn about diseases and test new drugs or lifestyle interventions. While every trial is different, there are a few things you should know about clinical trials if you’re considering taking part. Here are six things you should know about Alzheimer's clinical trials.

There are more than 500 active clinical trials for Alzheimer’s and other dementias in the U.S. They are designed to test different interventions, such as experimental drugs or exercise, new diagnostics, or various ways of caregiving. Some trials are designed to see whether specific interventions can prevent the disease in high-risk patients, while others focus on finding treatments for people across various stages of the disease.

Many people choose to participate because a clinical trial has the potential to help them, their loved ones, or future generations. While every clinical trial is different, here are some things to keep in mind if you want to participate.

Read our primer on
Alzheimer’s clinical trials

1. Many trials require a study partner to participate.

Study partners — usually spouses or adult children — are critical components of any clinical trials for Alzheimer’s and dementia. Researchers interview the study partner during the trial to help assess the participant’s cognitive function and ability to perform day-to-day tasks.

Rochelle Long, who was a study partner for both her aunt and her mother across several Alzheimer’s clinical trials, wrote that the role gave her a purpose and an opportunity to use her knowledge of her family’s experiences to help future generations.

The time commitment from study partners depends on the trial length and frequency of interview assessments.

Dr. Emily Largent: Making Clinical Trials Better for Participants

2. You might need to get a lumbar puncture or spinal tap.

A lumbar puncture, also called a spinal tap, is sometimes used during the screening process of a clinical trial. A needle is inserted into the spinal canal to take a sample of cerebrospinal fluid — which will be sent off and tested in a lab to confirm whether you have Alzheimer’s pathology in the brain.

Getting a lumbar puncture might feel uncomfortable, but it is not painful in most cases. On the morning of a procedure, you should eat a light breakfast and drink fluids. Make sure to take all of your prescribed medications before the procedure. Get in touch with your healthcare professional if you are taking blood thinners like aspirin or warfarin — they may ask you to hold off or change your medication schedule.  

Before the procedure starts, the healthcare provider will inject an anesthetic to numb the pain. Afterward, the needle for collecting cerebrospinal fluid will be inserted, and you may feel some pressure.

The procedure might sometimes cause some soreness for a few days afterward. Less than 1 percent of people who get this procedure might experience a headache. The soreness and headache can sometimes be treated with standard pain relievers and caffeine.

5 Ways Clinical Trials Test for Alzheimer’s

3. You might need to get an MRI.

An MRI scanner is a machine that uses a powerful magnet to image the human body. In many Alzheimer’s clinical trials, an MRI is used to look at the brain, and these scans can help doctors spot brain shrinkage, a sign of disease progression, or side effects like brain swelling or brain bleeding

Some trials also use a similar procedure called a PET scan, which involves injecting a harmless radioactive tag into the bloodstream that can stick to different biomarkers of Alzheimer’s — amyloid or tau. Another common form of PET scan uses a tracer that sticks to sugars and measures how much energy the brain uses. If the brain is less active and using less sugar, it is a potential sign of Alzheimer’s or another dementia. 

Before an MRI scan, you can eat and take medicines as usual; you’ll be asked to remove your clothes and change into a gown — it can be helpful to wear clothes that are easy to take off, and leave jewelry, watches, bracelets, and earrings at home. You’ll need to remove anything magnetic you might be wearing. 

During the MRI, you lie on a movable table that slides into an opening in a giant tube. A healthcare professional will monitor you from another room. The magnet inside the machine makes a lot of noise, so wearing earplugs or headphones might help block out the sound. For Alzheimer’s, an MRI scan typically lasts 45 minutes.

4. Not all trials share your data with you at the end.

Many people enter clinical trials to learn more about how the disease affects them. You and your care partners might be interested in accessing your research results, like MRI scans or cognitive tests, but in some trials, the researchers are unable to share your trial data with you. 

Drug companies and researchers often don’t even release or publish all the data they collect and analyze. In the U.S., although the FDA requires the release of this data within a year of the trial ending, less than half of the companies behind clinical trials that were due to report results by January 2018 were compliant.

Why AC Immune’s Alzheimer’s Vaccine Failed Phase 2 Trials, and What’s Next

5. You might never learn if you receive the drug or a placebo in a drug trial.

To determine whether a new drug works, clinical trials randomly assign participants to one of two groups. One group receives the study drug, while the other receives a placebo. In double-blinded trials, neither the trial participants nor the clinical trial staff know who is in which experimental group. 

Depending on the clinical trial, the researchers might ask you afterward if you’d like to know whether or not you received the placebo, but this is not a strict requirement for clinical trials. In some cases, participants who received the placebo will be offered the drug as part of an extension of the study.

Leqembi Clinical Trials Aren’t Over—Half of Participants Will Get the Drug for Free

6. The trial might be canceled at any time.

The researchers or drug company sponsoring a trial can cancel it at any time for various reasons — it could be the drug isn’t working, or there are logistic problems with continuing. This year, citing financial concerns, Biogen announced it was withdrawing its anti-amyloid drug Aduhelm from the market and canceling an ongoing trial measuring its effectiveness.

According to Emily Largent, an assistant professor in medical ethics and health policy at the University of Pennsylvania, many trial participants face this problem. Largent told Being Patient that some participants heard their study ended while scrolling through the news on their smartphones rather than from trial staff.

Phil’s Journal: When Alzheimer’s Trials Are Cancelled, Notifying Study Participants in the Most ‘Humane’ Way

The benefits of participating in clinical trials

Everyone that participates in clinical trials furthers the understanding of Alzheimer’s disease and dementia. 

If a trial shows that a drug or treatment is ineffective, it provides important data for researchers, which can help them develop better treatments in the future. In the case that a drug does work, you might be one of the first people to receive the treatment before it’s available anywhere else. Your health is also monitored closely, and you may receive frequent checkups from an experienced healthcare team during the trial. 

Deciding whether to participate in a clinical trial is a decision for you and your family to make together. While you might experience some discomfort or side effects from participating, you will also help researchers develop new treatments for Alzheimer’s.

A Trial Participant’s Inside Look at New Alzheimer’s Drug Leqembi

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