This series of bite-sized episodes contains important information you need to navigate the evolving world of Alzheimer’s disease (AD) research. Dr. Marc Agronin and Dr. Richard Isaacson discuss the recent advances in AD and provide practical approaches for prevention, diagnosis, and treatment.
Clinical Trials in Alzheimer's Disease
Clinical Trials in Alzheimer's Disease
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This is CME on ReachMD, and I'm Dr. Marc Agronin. I'd like to talk to you today about clinical trials in Alzheimer's disease. So one thing that's clear is the only way to advance the field of study into Alzheimer's disease to try to find better ways of both diagnosis and treatment is through clinical trials. There are many, many trials out there. If you go to clinicaltrials.gov, you can identify literally hundreds of them focused on Alzheimer disease. These range from smaller trials, some of which are open label, so someone knows what treatment they're getting or what type of diagnostic they're getting, to much larger trials, which are always going to be double-blind and placebo-controlled, randomized controlled trials. And the bottom line is there, is that we don't know if it works or not, and so it's important that we test individuals getting the treatment versus individuals on placebo.
It's important to encourage individuals, especially in earlier stages of this disease, to at least consider being part of a clinical trial, because without that, we're never going to find an effective treatment here. Part of being in a trial is meeting certain criteria. Now many studies today really are looking for individuals in very early stages. And this can be a challenge for someone who already may be as advanced to more moderate to severe stages, at least in terms of treating the disease itself. But there are many clinical trials also looking at associated neuropsychiatric symptoms of Alzheimer's disease, such as psychosis or agitation or depression. And these are often open to individuals with more advanced stages.
One of the benefits of being in a clinical trial is that someone is going to get a lot of extra attention from a clinical team. This follow-up can help advance diagnosis. Sometimes you need more advanced diagnostic studies to even qualify for the study, and these may be PET scans or other studies which are not covered by insurance or which may be more difficult to access. And so the clinical trial gives you those diagnostics to determine whether you even meet criteria, whether you're going to have the disease in the first place.
There's increased surveillance in terms of what's going on with someone clinically. And especially if someone gets the actual treatment, there could be benefit; this could be the next medication that's going to come on the market.
Obviously, people have concerns about this being an experimental treatment. There could be potential side effects that we're not aware of. Obviously, if someone is on a placebo over time, and sometimes trials can be 1 to 2 years, it means that they might not be getting any benefit from the trial itself or from the medication itself. There can be side effects that we're not aware of. So these are things that need to be taken into consideration.
But I would say this is the key takeaway: everyone with a potential or known diagnosis of Alzheimer's disease should be considered for participation in a clinical trial. These are meant to be free. In fact, studies will pay a stipend to cover costs. You never have insurance billed on this. They're under FDA regulation. And so the individuals running these trials, the centers need to strictly adhere to certain guidelines. But it brings great benefit, potentially to individuals participating, but especially in terms of the field itself. We have got to find a better way to treat this disease. Clinical trials are the only way to go.
So with that, our time is up today. But thank you for listening. And hopefully this information has been helpful. Thank you.
You have been listening to CME on ReachMD. This activity is provided by Prova Education and is part of our MinuteCME curriculum.
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In accordance with the ACCME Standards for Integrity and Independence, Global Learning Collaborative (GLC) requires that individuals in a position to control the content of an educational activity disclose all relevant financial relationships with any ineligible company. GLC mitigates all conflicts of interest to ensure independence, objectivity, balance, and scientific rigor in all its educational programs.
Marc E. Agronin, MD
Senior Vice President, Behavioral Health
Chief Medical Officer, MIND Institute
Miami Jewish Health
Consulting Fees: Eli Lilly and Company, Otsuka America Pharmaceuticals Inc.
Contracted Research: AgeneBio, Alzheon, Inc, Avanir Pharmaceuticals, Inc, Eli Lilly and Company, F. Hoffman La-Roche Ltd, Janssen Global Services, LLC, Sage Therapeutics, Inc.
Richard S. Isaacson, MD
Director, Center for Brain Health
Florida Atlantic University
Boca Raton, FL
No relevant relationships reported.
- Cindy Davidson has nothing to disclose.
- Amanda Hilferty has nothing to disclose.
- Nick Lombardi has ownership interest in Vertex Pharmaceuticals.
- Libby Lurwick has nothing to disclose.
- Colleen Resnick has nothing to disclose.
After participating in this educational activity, participants should be better able to:
- Contrast how the slowing of Aβ plaques, as shown in recent clinical trial endpoints of slowing cognitive decline with immunotherapies, differs from current standard of care results in Alzheimer’s disease (AD)
- Recognize the positive impacts of earlier identification of AD in slowing the course of the disease
- Analyze how the mechanisms of action of newer investigational therapies relate to the molecular mechanisms that drive AD progression
- Analyze biomarkers for functional impairment, neuronal loss, and protein deposition that are assessable by neuroimaging or cerebrospinal fluid analysis for diagnosis, staging, and treatment outcomes
- Compare the monoclonal antibodies currently under study to treat AD
- Evaluate new agents that may be appropriate for patients with mild cognitive impairment (ie, the role of imaging)
This activity is designed to meet the educational needs of neurologists, primary care physicians, and other healthcare professionals that diagnose and treat patients with Alzheimer’s Disease.
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Global Learning Collaborative (GLC) designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Global Learning Collaborative (GLC) designates this activity for 1 nursing contact hour. Nurses should claim only the credit commensurate with the extent of their participation in the activity.
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