Innovation In Alzheimer’s Disease Research: Home-Based Patient Self-Assessment In Clinical Trials To Be Undertaken by National Institute of Aging Nationwide Alzheimer’s Consortium

Madison, WI Can home-based patient self-assessment for Alzheimer’s Disease be just a phone call away? Physicians and researchers at Healthcare Technology Systems, Inc. (HTS), a Madison, WI based provider of electronic clinical research and healthcare technologies, think so. HTS won a sub-award as part of the Alzheimer’s Disease Cooperative Study (ADCS), and will be collaborating with the $52 million, six year, federally established consortium conducting clinical trials on Alzheimer’s Disease (AD). The award is part of the cooperative agreement between the National Institutes of Health’s (NIH) National Institute on Aging (NIA) and the University of California, San Diego (UCSD), which coordinates the consortium of nearly 70 sites in the United States and Canada.

The purpose of the ADCS is to test drugs for their effectiveness in slowing down the progression or treating the symptoms of AD. Specifically, researchers will focus on therapies aimed at affecting the beta amyloid peptide and the tau protein, both involved in the development of AD.

Among the studies to be undertaken by the ADCS is an evaluation of home-based assessments. Older individuals, particularly the very elderly, often have physical, social, and health limitations that make it difficult for them to take part in research trials. The ADCS study, conducted in people aged 75 and older, will examine the use of HTS’ computer automated telephone technology and data management system to assess cognitive, functional, and other factors in the home environment to see how home-based assessments might be used to monitor the health and function of the elderly in a convenient, familiar fashion. This approach could significantly reduce the cost and increase the feasibility of participation in long-term, costly clinical trials.

Under the leadership of James Mundt, PhD, HTS developed and demonstrated the value of computer-based Interactive Voice Response (IVR) technology in gathering cognitive performance data directly from elderly patients in previous clinical research supported by Phase I and Phase II Small Business and Innovation (SBIR) grants awarded by the NIA. Results from the Phase I study lead to an innovative telephone-based cognitive screening assessment, named Telephonic Remote Evaluation of Neuropsychological Deficits (TREND), and were published in the Archives of Internal Medicine (Volume 161: 2481-2487). Results from the Phase II study, a six-month longitudinal study of Mild Cognitive Impaired and Mild Alzheimer’s Disease patients, will be published in 2007.

According to Chris Snyder, CEO and President of HTS, “The sub-award from the ADCS builds on many years of patient – computer experience, research, and innovation. HTS successfully delivered 10 different electronic patient self-assessments, and the randomization services, in the recently concluded Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial. STAR*D was a 6 year, 4,000 patient, $35 million dollar study supported by the National Institute of Mental Health. By enabling clinically valid, home-based, patient-self assessment for Alzheimer’s Disease, TREND and other technologies being developed by HTS for the ADCS, will bring significant value to pharmaceutical clinical research, primary care prevention efforts, and mental wellness clinic operations.” HTS’ technology, used in over 200 pharmaceutical research trials, offers advantages in data collection and processing that reduces the cost of clinical trials and shortens the time to bring a drug to market. In clinical settings, doctors could use TREND to measure longitudinal change in a patient’s cognitive performance from the comfort and safety of a patient’s own home.

Alzheimer's Disease affects an estimated 4.5 million people in the U.S. It increases dramatically with age, affecting approximately 40-50 percent of people age 85 and older. The numbers of people with AD are expected to rise dramatically with the aging of the population over the next decades.

The NIA, one of 27 institutes and centers at the NIH, is part of the U.S. Department of Health and Human Services. It leads the federal effort to support and conduct basic, clinical, and social and behavioral studies on aging generally and AD specifically. NIA supports the Alzheimer's Disease Education and Referral (ADEAR) Center, which provides information on clinical studies and other research to the public, health professionals, and the media. ADEAR can be contacted toll-free at 1-800-438-4380 or by viewing www.nia.nih.gov/alzheimers.

Healthcare Technology Systems, led by John H. Greist, MD, James W. Jefferson, MD, David J. Katzelnick, MD, and Chris Snyder, MBA, is the world leader in creating, developing and implementing clinical IVR systems. HTS currently offers more than 50 clinically validated electronic patient-self assessments. In August 2004, FDA indicated acceptance of patient self-report assessments as primary outcome measures in depression studies. HTS also conducts research in a variety of areas, including creation and validation of assessments, development and validation of computerized therapeutic interventions, disease management programs, health services research, and protocol analysis.

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