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Trial to Test App Alerting for Dementia-Linked Drugs

Phone and keyboard


15 July 2019. A mobile and computer app that alerts older citizens about a class of drugs associated with Alzheimer’s disease will soon be tested in a clinical trial. A team at Indiana University and Purdue University in Indianapolis, and the affiliated Regenstrief Institute, received a 5-year, $3.5 million grant from National Institute on Aging, part of National Institutes of Health, to fund the trial.

The trial will test an app designed for smartphones, tablets, and desk or laptop system called Brain Safe that aims to reduce exposure of older individuals to anticholinergic drugs. Anticholinergics block the actions of a neurotransmitter, a signaling chemical in the brain, called acetylcholine found in motor neurons to stimulate muscle movement, and plays a key role in memory and cognition. These drugs are found in medications to treat a wide range of disorders from depression and sleep disorders to allergies and heart failure.

Researchers led by Richard Holden, director of Indiana’s Health Innovation Lab and a medical school faculty member, developed Brain Safe to alert people who take anticholinergic drugs, particularly older persons, about their risks. The team says one in three older people in the U.S. take anticholinergic drugs, despite increasing evidence that higher use of these drugs is associated with cognitive impairment, Alzheimer’s disease, and other forms of dementia.

Brain Safe is based on research on medical decision making that shows older individuals are interested and concerned about side-effects of over-the-counter drugs, but did not know about age-related risks associated with anticholinergics. The study team, including Holden, constructed a conceptual model of medical decision-making behavior that helped design Brain Safe. A later project tested the feasibility of an early version of the mobile app that show software of this kind is easy to use and can encourage older individuals to raise the issue of anticholinergics with their doctors.

The latest app includes an calculator to gauge an individual’s risk of exposure to anticholinergic drugs, tips to start a conversation with one’s doctor about anticholinergics, and multimedia content. The trial to test Brain Safe aims to enroll 700 individuals, with participants randomly assigned to use Brain Safe or an unrelated WebMD Health Assessment. Individuals taking part will be assessed before using the apps, then at 6 and 12 months for anticholinergic exposure, verified by dispensing records.

“Interventions to lower this risk are urgently needed,” says Holden in a university statement. “We hope this app will raise awareness and provide information to people, allowing them to take action to protect their brain health.”

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