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Taking Part in the Search for the Cure

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Getting involved in clinical trials is an effective way to advance the pursuit for better treatments and even a cure for Alzheimer’s disease.

As we learn more about Alzheimer’s, the facts and figures are alarming. It’s estimated that more than 5 million people in the United States are living with the disease, and as many as 41.8 percent of assisted living and other residential care residents have Alzheimer’s or other dementias. By the year 2050, the number of Americans with Alzheimer’s is expected to reach 16 million.

For every person with Alzheimer’s, there are many family members, caregivers, and friends whose lives are also affected. While we haven’t yet found a cure, there’s still hope.

Investing in Alzheimer’s research has yielded many exciting breakthroughs. In 2010, scientists at the Fisher Center for Alzheimer’s Research laboratory discovered a gamma-secretase activating protein (gSAP) that’s central to creating beta-amyloid, which can kill brain cells and cause Alzheimer’s when in overabundance. Clues like these help us to better understand Alzheimer’s and can influence how we treat the disease.

Scientific discoveries advance Alzheimer’s research, and clinical trials are another important piece of the puzzle. Before a patient can even receive an Alzheimer’s medication, it must be tested in a clinical trial. In the search to find a cure, clinical trials bring us one step closer.

The Importance of Clinical Trials
A clinical trial is a research study of how certain interventions (a medication, procedure or behavior) affect the biomedical or health outcomes in human volunteers or patients. It’s also a fast track to finding Alzheimer’s treatments that will work.

“Without clinical trials, we can’t prove if a drug is helpful,” says John M. Ringman, M.D., M.S., Clinical Professor at the Department of Neurology at University of California, Los Angeles and the Easton Center for Alzheimer’s Disease Research. “In order to do so, you need to perform appropriately controlled blinded randomized studies.”

Sometimes, clinical trials turn up surprising results. Lately, we’ve been hearing a lot about estrogen and its effects on Alzheimer’s. Early studies were hopeful that estrogen-containing therapy would protect the brain from Alzheimer’s, but clinical trials challenged that thought.

“In fact, all the clinical trials suggested that it’s not effective and may actually be damaging,” says Gary Gibson, Ph.D., Director for the Laboratory for Mitochondrial Biology and Metabolic Dysfunction in Neurodegeneration at Burke Medical Research Institute and a professor of neuroscience at Weill Cornell Medical College. “In Alzheimer’s disease, you want to delay the degeneration and if you find one way to do that, then maybe you can improve it with additional therapy or changing dosages.” When clinical trials fail, they provide us with insight for future research.

Clinical trials wouldn’t be effective without volunteers. Participants not only play an active role in their own health care, they’re also contributing to Alzheimer’s research.

Clinical trials wouldn’t be effective without volunteers.
Participants not only play an active role in their
own health care, they’re also contributing to
Alzheimer’s research.

The Latest in Alzheimer’s Clinical Studies
Currently, we don’t have an Alzheimer’s drug that will prevent or reverse or even stop the disease from worsening but with every clinical trial, even those that fail, we inch toward an answer.

“Now there is increasing emphasis on intervening earlier in the course of the disease, or even before symptoms appear, to prevent the disease from manifesting symptoms in those who are either genetically predisposed or have some biomarker evidence that the pathology of the disease is already in progress,” says Dr. Ringman.

At UCLA, Dr. Ringman is studying a rare gene that causes Alzheimer’s at a young age (late 30s to late 50s). In families where this gene has been identified, each child is at a 50 percent risk for inheriting that gene and developing the disease. “Because the age of onset is pretty consistent, you can not only predict who in the family is going to get the disease, but also about what age,” adds Dr. Ringman.

Meanwhile, Burke Medical Research Institute researchers are studying the brain’s reduced ability to use glucose and how that contributes to Alzheimer’s disease. “We found that some critical proteins involved in the brain using glucose are reduced, and these proteins require vitamin B1, or Thiamine, in order to work,” says Dr. Gibson. “If we can get the brain to use the glucose better, we think we’ll be able to delay degeneration.” This hasn’t been tested in humans, but researchers are planning a clinical trial.

We don’t have an Alzheimer’s drug that will prevent or reverse the disease but with every clinical trial, we inch toward an answer.

We don’t have an Alzheimer’s drug that will prevent or reverse the disease but with every clinical trial,
we inch toward an answer.

How to Further Alzheimer’s Research
Clinical trials wouldn’t be effective without volunteers. Participants not only play an active role in their own health care, they’re also contributing to Alzheimer’s research.

From systolic blood pressure intervention to dominantly inherited Alzheimer’s, there are more than 150 active clinical trials in the U.S. investigating how to diagnose, treat, prevent, and cure Alzheimer’s disease. At this very moment, 70,000 volunteers are being sought for this valuable research.

Researchers are looking for a diverse group of people, including healthy individuals who don’t have Alzheimer’s, those who have already been diagnosed, those who have a family history of Alzheimer’s, and people of all ages and races. To be deemed eligible, certain criteria must be met, such as age, gender, stage of disease, other medical conditions, and previous treatment history.

There are many factors to consider before participating in an Alzheimer’s clinical study. Keep in mind that participants may receive a placebo, or an inactive substance made to resemble the drug being tested. There’s also the risk of side effects from the treatment. When this happens, additional safety monitoring may be recommended or the study may be discontinued.

What to Expect
Every clinical trial is different, but participants typically go through a prescreening and screening process. Prescreening involves being asked about medical history, medications, diagnosis, and the stage of their illness. Screening will involve further questioning and possibly blood tests, cognitive tests or imaging.

If it’s a drug trial, the participant may receive a free drug. Other trials may require additional procedures or testing, such as EKGs, lumbar punctures or spinal taps.

The length of a clinical trial can vary from as few as three months to as long as 18 months, but the volunteer will know that up front.

Before enrolling, the patient will be educated on all of the key details about the clinical trial during the informed consent process. Typically, an informed consent document outlining possible benefits and risks is signed before the trial. This is also the perfect time to bring up any and all questions the participant might have.

Questions to Ask
It’s important to know as much as possible before joining a clinical trial and participants and caregivers should be armed with plenty of questions before making a decision. This is just a starting point, but questions to ask can include the following:

• How long will the study last?
• What is being studied?
• How often will I have to show up?
• What will I do at the appointments?
• What kinds of tests or procedures will I receive?
• Are hospital stays required?
• What are some of the possible side effects or reactions?
• What kind of follow-up is involved?
• Can I continue other prescribed Alzheimer’s treatments?
• Will I have to pay for anything?
• Will transportation or any other accommodations be provided?

Where to Start

There are many ways to find Alzheimer’s clinical trials. Trials are being run by doctors in their offices, in clinics, hospitals and universities. “The best way to do a clinical trial,” says Dr. Ringman, “is to meet with someone one on one. Usually, as we see patients, we’ll tell them about clinical trials and if they want to know more, we’ll give them the details.” ClinicalTrials.gov, managed by the National Library of Medicine at the National Institutes of Health, lists available clinical trials in 50 states and 187 countries. The website for the National Institute on Aging has an Alzheimer’s clinical trial search at http://www.nia.nih.gov/alzheimers/clinical-trials. To get involved with an Alzheimer’s clinical trial with Burke Medical Center, visit www.burke.org. For more information on Alzheimer’s clinical trials at UCLA, visit http://www.eastonad.ucla.edu.
Alzheimer’s may be a devastating disease, but by participating in clinical trials, we can help find some answers.

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