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Wednesday, June 14, 2023

Coping With A Brain Disorder

Advances in clinical trials for Alzheimers

Alzheimer’s disease is a progressive brain disorder that impairs memory, thinking and behavior. The impact of Alzheimer’s can be devastating, not only for those diagnosed but also for their families and loved ones.

However, there is good news: There have been advancements in Alzheimer’s research, particularly in the realm of clinical trials. Clinical trials are scientific studies conducted to evaluate the safety and effectiveness of new interventions. In Alzheimer’s, these trials focus on potential treatments that could slow down or halt the progression of the disease, enhance cognition or improve the quality of life for patients.

Clinical trials consist of several phases:

• Phase 1 focuses on testing the treatment’s safety in a small group.

• Phase 2 gathers more data on effectiveness and dosage.

• Phase 3 compares the treatment to existing options in a larger group.

• Phase 4 monitors its long-term safety after approval.

These phases ensure rigorous evaluation before treatments are available to patients.

Clinical trial opportunities at LSU Health Shreveport include the New Ideas study (www.ideas-study.org/), which enrolls African American and Hispanic patients interested in receiving an amyloid PET scan. The goal is to determine the utility of amyloid PET scans in treating Alzheimer’s disease and is funded by Medicare. The New Ideas study researchers can be reached at 866-507-7254 or newideas-participant@alz.org.

In addition, LSU Health Shreveport’s Center for Brain Health researchers are examining a biomarker for the vascular contribution to Alzheimer’s disease. They are looking for people over 55 with and without the disease, especially men. The study involves taking some cognitive tests, giving a blood sample and receiving an MRI. Questions about this study can be directed to 318-656-4800 or CB- HResearch@lsuhs.edu.

One of the most active areas of clinical trials research in Alzheimer’s disease involves targeting the build-up of proteins called amyloid plaques in the brain. These plaques likely play a significant role in the development and progression of Alzheimer’s. Drugs like Donanemab, by drug maker Eli Lilly, and Leqembi, by drugmakers Eisai and Biogen, are examples of these immunotherapies with FDA Accelerated Approval post phase 3 to treat early Alzheimer’s.

Another approach being investigated in clinical trials is focused on the tau protein, which forms twisted tangles within brain cells in Alzheimer’s disease. These tangles disrupt cell communication and ultimately lead to the death of brain cells. Researchers are investigating off-label medications, such as Nilotinib and Salsalate, that may block the abnormal formation of tau protein or enhance its removal, slowing down the disease progression. These medications have passed trial Phase 2 and 1B, respectively.

Furthermore, clinical trials examine the potential benefits of anti-anxiety medications, such as lorazepam and oxazepam, or neuroleptic drugs to target paranoia, confusion and irritability. These medications are in trial phase 5, but uses for Alzheimer’s are considered off-label. The Ochsner Medical Center in New Orleans is recruiting Alzheimer’s patients to test the efficacy of seltorexant by Johnson & Johnson versus a placebo for controlling agitation and aggression.

Another trial recruiting in Louisiana is the EAD501 in Marrero, La., by Tandem/ Clincloud LLC. This randomized, placebo-controlled, double-blind, parallelgroup study will assess the safety, tolerability and potential efficacy of Trappsol Cyclo, a cholesterol drug, in patients with early-onset Alzheimer’s disease (EAD).

In addition to drug-based trials, researchers are exploring non-pharmacological interventions, such as lifestyle modifications like exercise. Two clinical trials for Alzheimer’s disease are currently recruiting patients in Baton Rouge, La., at the Pennington Biomedical Research Center. The studies are called “Reducing African Americans’ Alzheimer’s Disease Risk Through Exercise,” or RAATE, and were designed to determine the effects of physical activity on risk factors for Alzheimer’s Disease in older African American adults. The intervention group will increase their physical activity to match federal physical activity guidelines.

These trials aim to uncover whether activities like exercise, cognitive training and social engagement can positively impact cognitive function and delay the onset of Alzheimer’s symptoms. These lifestylebased trials provide hope that simple, ev- eryday choices may play a role in reducing the risk or slowing down the disease progression.

Participants play a vital role in ensuring the success and safety of clinical trials.

Without individuals willing to volunteer, these trials wouldn’t be possible. If you or a loved one are interested in participating, it’s important to contact your local research institutions, clinics or Alzheimer’s advocacy groups to learn more about ongoing trials in your area. Joining a clinical trial gives you access to potentially groundbreaking treatments and contributes to advancing Alzheimer’s research.

Lastly, it’s important to keep realistic expectations about clinical trials. They are a rigorous scientific process; not all trials result in breakthrough treatments. However, every trial provides valuable insights and data that help researchers refine their understanding of the disease, identify potential avenues for future studies, and ultimately bring us closer to finding a cure.

To learn more, check clinicaltrials.gov for trials in your area.

Alzheimer’s and Clinical Trial Research: Elizabeth Disbrow, Ph.D., is the director of the Center for Brain Health and a professor of neurology at LSU Health Shreveport, and Chijindu Eke is a Master of Public Health program intern at LSU Health Shreveport.


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