Saint Louis University Studies a Medical Food for Alzheimer’s Disease
|George Grossberg, M.D.|
ST. LOUIS – In a new multicenter research study, Saint Louis University is studying the use of a medical food for Alzheimer’s disease. Investigators want to know if increasing ketone body levels will improve memory and other mental skills.
Alzheimer’s disease is a progressive brain disease that impairs orientation, memory, judgment, decision-making, problem solving and activities of daily living.
The illness is currently incurable and is the leading cause of dementia in the elderly, says George Grossberg, M.D., director of geriatric psychiatry at SLU and principal investigator for the study.
There are over five million older adults in the United States with dementia, two-thirds of which have Alzheimer’s disease.
One of the side effects of Alzheimer’s disease is glucose hypo-metabolism – or a glucose deficiency. The brain uses glucose as its primary source of energy for neurons. As Alzheimer’s disease progresses, the glucose hypo-metabolism worsens.
Researchers will test a medical food as a source of ketone bodies, which can substitute for glucose as an energy source for neurons.
“Ketone bodies can supplement glucose in brain diseases, such as Alzheimer’s disease, where there is a shortage of glucose for brain cells to utilize,” said Grossberg.
Investigators will enroll men and women who are 66 to 90 years old who have been diagnosed with mild to moderate Alzheimer’s disease in this randomized, double-blind, placebo-controlled study. Participants will take a daily dose of the study medication or a placebo.
The safety and effectiveness of the investigational drug will be evaluated through five clinic visits and three phone calls over the course of 26 weeks. All participants must be accompanied to the clinic visits by a caregiver.
After the 26-week study medication period has ended, participants will have the option to take part in the open-label phase – where all participants receive the study medication. The open-label phase will last an additional 26 weeks.
Saint Louis University hopes to enroll 12 participants for the trial and is the only study center in the St. Louis area. A total of 480 patients will participate in the study at approximately 60 different clinics across the country.
All study medications and tests will be provided at no costs to participants. This study is sponsored by Accera, Inc.
To learn more about the study, call Saint Louis University at (314) 977-4900 and reference IRB number 23360.