IU & Regenstrief Conducting Nation’s First Randomized Controlled Dementia Screening Trial

NDIANAPOLIS -- Researchers from the Indiana University Center for Aging Research and the Regenstrief Institute are conducting the nation’s first randomized controlled dementia screening trial to weigh the benefits and risks of routine screening for dementia. The results of the five-year trial will help policy-makers, individuals and families weigh the pros and cons of routine screening of adults age 65 and older.

The Indiana University Dementia Screening Trial: The IU Choice Study is enrolling 4,000 participants randomized into usual care or screening. Those who receive usual care will not be screened for dementia on a routine basis. Patients randomized to the screening track will receive dementia screening, and those whose screening results are positive for cognitive impairment will participate in the Healthy Aging Brain Care collaborative dementia care program. Patients from both study arms will be followed for at least 12 months.

"A fundamental tenet of any screening program is that it should reduce individual and societal burdens,” said Regenstrief Institute investigator Malaz Boustani, M.D., MPH, the study’s principal investigator. He is the associate director of the IU Center for Aging Research and an associate professor of medicine at the IU School of Medicine. He sees patients at the Wishard Healthy Aging Brain Center and is also an IU Health physician. "Until we have data we can’t make the right decision on whether or not physicians should conduct routine dementia screening of individuals who have no symptoms of memory problems. IU Choice is the first step in the direction of acquiring that critical data."

In 2003, the U.S. Preventive Services Task Force reviewed existing evidence regarding dementia screening in primary care and reported it could not determine whether the benefits outweighed the harms.

According to Dr. Boustani, who was a lead author of the U.S. Preventive Services report, this lack of evidence persists a decade later. Yet since 2011, the Center for Medicare and Medicaid Services has reimbursed physicians for an annual wellness visit that includes detection of cognitive impairment, he said.

“We need to know whether routine screening serves patients, families and society," said Dr. Boustani, who is a geriatrician and health services researcher. "Will routine dementia screening ensure better care and better health at a lower cost, or will it be a burden to the health care system with little benefit to older adults? Is early recognition of cognitive decline helpful? Should we wait until dementia becomes symptomatic, or should primary care doctors screen everyone?”

“We don't know enough to tell doctors to screen all their older patients for dementia. There is just not enough data to make the right decision on routine dementia screening. All these questions require answers before recommendations can be made.”

Dr. Boustani and colleagues previously conducted a study on the stigma associated with dementia screening. Almost 90 percent of the 554 people in the study, who ranged in age from 65 to 96, indicated willingness by undergoing actual screening.

Routine screenings for conditions such as colon cancer have improved patient health and reduced societal burdens of diseases. However, screening may cause side effects, excessive costs and controversy, as in the case of prostate cancer screening.

The IU Choice Trial is an academic-community partnership served by health information technology. Patients of 10 Eskenazi Medical Group, Wishard Health Services and IU Health primary care clinics are eligible to participate in the ground-breaking trial. The study is supported by the National Institute on Aging of the National Institutes of Health through award number R01AG040220.

Co-investigators of the study are Regenstrief Institute investigators Greg Sachs, M.D., Christopher Callahan, M.D., and Paul Dexter, M.D. Dr. Sachs is an IU Center for Aging Research scientist and director of the Division of General Internal Medicine & Geriatrics at the IU School of Medicine. Dr. Callahan is founding director of the IU Center for Aging Research and Cornelius and Yvonne Pettinga Professor in Aging Research at the IU School of Medicine. Dr. Dexter is associate professor of clinical medicine at the IU School of Medicine and chief medical information officer for Wishard Health Services. Drs. Sachs and Callahan as well as Dr. Boustani see patients at the Healthy Aging Brain Center at Wishard. Amie Frame, MPH of the Regenstrief Institute is the study research manager.