Interactive Tool to Boost Participant Numbers in Alzheimer's Studies, Speed Clinical Advances

Caroline Cassels

July 14, 2010

July 14, 2010 (Honolulu, Hawaii) — A new interactive tool that uses the telephone and the Internet to boost the number of participants in Alzheimer's studies by rapidly matching prospective subjects to the appropriate clinical trial has been launched by the Alzheimer's Association.

By significantly increasing the number of participants in Alzheimer's trials, leaders of the initiative, which is described as the first of its kind in Alzheimer's disease (AD), hope to speed sorely needed advances in prevention, diagnosis, and treatment.

It is estimated that at this time, 5 million people in the United States suffer from AD. However, this number is expected to triple by 2050, with an estimated cost to the healthcare system of $20 trillion.

"Clearly we can't afford this, and clearly [such costs] are unsustainable and will bankrupt the healthcare system. We cannot allow this to happen, and as a research community, we have to intervene," Ronald Petersen, MD, PhD, chair of the Alzheimer Association's Medical and Scientific Advisory Council and director of the Mayo Alzheimer's Disease Research Center at the Mayo Clinic College of Medicine, in Rochester, Minnesota, told reporters attending a press briefing here at the Alzheimer's Association International Conference on Alzheimer's Disease 2010.

Dr. Ronald Petersen

Dr. Petersen pointed out that the efficacy of current treatments for AD — which include 5 agents approved by the US Food and Drug Administration — is "modest at best," and that the treatments address symptoms of the disease but do not affect the underlying disease process.

"The Pea in the Bottle"

Apart from funding, the single biggest barrier to developing effective disease modifying therapies is the recruitment of sufficient numbers of subjects for clinical trials. "It's the pea in the bottle," said Dr. Petersen.

Market research conducted by the Alzheimer's Association shows that although 75% of physicians have referred patients to clinical trials, only 25% have referred individuals to Alzheimer's studies, and that the primary reason for this is lack of awareness.

This lack of awareness can have, and has had, a negative effect on trial enrolment. Dr. Petersen noted that a few years ago, researchers conducting an AD trial of the nonsteroidal anti-inflammatory drug rofecoxib had to broaden recruitment criteria for mild cognitive impairment because they had an inadequate number of participants.

Confidential and free, TrialMatch is designed to make it easy for patients and their physicians to identify and enroll in clinical trials providing patients access to cutting-edge research and treatments currently being tested.

TrialMatch listings include institutional review board–approved AD, mild cognitive impairment, and other dementia trials currently taking place throughout the United States. The listings come from publicly available sources such as https://clinicaltrials.gov. However, all studies listed are being contacted to get updates on recruiting status and local sites.

A Trial for Every Interested Person

According to Reisa Sperling, MD, director of the Center for Alzheimer's Research and Treatment at Brigham and Women's Hospital and Massachusetts General Hospital in Boston, TrialMatch will fulfill both the physician and patient need for information about Alzheimer's research and get it to them faster.

Dr. Reisa Sperling

"We already have a huge number of studies that are available for every stage of AD, and yet all of them are slow to enroll. The number one barrier to that is awareness. So primary care doctors who see far and away the majority of AD in the community don't know about these opportunities," said Dr. Sperling.

"They don't know about the local opportunities or some of the national efforts, and we need to get that information to them in a way that they can use in their offices when they only have 7 minutes to see a patient," she added.

Dr. Sperling noted that the major advances that have occurred in pediatric oncology over the past decade have been a direct result of increased enrolment in clinical trials, and it is the hope that through TrialMatch, the same success can be achieved in AD.

Dr. William Thies

"Somehow we've got to widen the bottleneck and get people into trials rapidly. It can't take 18 months or 24 months to test each one of these drugs — we've got to get that down to 6 months and get every interested person into a trial that is right for them," said Dr. Sperling.

According to the association's Chief Medical and Scientific Officer William Thies, PhD, there are currently more than 100 Alzheimer's clinical trials in the United States that are actively recruiting participants. Patients and physicians can access the tool at the TrialMatch Web site or by calling 1-800-272-3900.

Supported entirely by the Alzheimer's Association, the estimated cost of TrialMatch — including promotion of the program to clinicians and the public — is $1.2 million this year.

Alzheimer's Association International Conference on Alzheimer's Disease 2010. Presented July 12, 2010.

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