Oklahoma City lab seeks participants for Alzheimer's prevention study
Oklahoma City — An Oklahoma City research firm is seeking people to test whether new medications could delay the onset of Alzheimer's disease.
IPS Research, 1111 N Lee, is one of more than 100 sites worldwide participating in a trial of two compounds. The compounds, known as CAD106 and CNP520, are meant to tamp down on the BACE enzyme, preventing amyloid proteins from building up in the brain, said Dr. Louise Thurman, founder of IPS.
The brains of people with Alzheimer's disease have plaques of amyloid and tangles of tau, another protein. It isn't clear if amyloid is the most important factor causing Alzheimer's disease, however, because some people have plaques in their brains but no symptoms. Drugs meant to reduce the buildup of amyloid have consistently disappointed, but it's not clear if they're aiming at the wrong target or are given too late in the disease to have an effect.
“The disease process really happens years before people have symptoms,” Thurman said.
The trial is open to people ages 60 to 75 who have a gene that raises their risk of Alzheimer's, but don't currently have cognitive impairment. Testing for the risky gene, APOE4, is part of the process of joining the study.
Some of those who qualify will receive one of the two drugs, and others will get a placebo. At the end of the trial, researchers will compare how many people in each group develop cognitive impairment, and how long it took the disease to emerge. If the group that got one of the pills does better than the placebo group, trial sponsors Novartis and Amgen could seek approval from the U.S. Food and Drug Administration to sell the medication.
Participants have to commit to regular follow-ups to assess their mental and medical conditions. As with any trial, there's no guarantee patients will benefit, and some may experience unexpected side effects.
A spouse, child or close friend who regularly observes the participant closely also would have to make the time commitment to provide information about any behavioral changes that could signal the participant has developed dementia.
The trial will include about 3,000 people worldwide, and could last as long as eight years, Thurman said. Participants can stay in the trial until they develop cognitive impairment, which would suggest the drug isn't helping them, she said.
“If patients can retain independence ... that's the golden ticket,” she said.
For more information, visit www.generationprogram.com.