Testing a drug to delay cognitive decline
Do you or a loved one have trouble remembering appointments, conversations or even what happened yesterday? Have you noticed that it’s harder to make decisions or follow a recipe?
These are symptoms of mild cognitive impairment (MCI). About 15 to 20% of people over the age of 65 have MCI, which some doctors consider an early stage of Alzheimer’s disease or other kind of dementia.
Now, Johns Hopkins University School of Medicine is enrolling people ages 55 to 85 in a global study to see if an epilepsy drug can slow or even prevent the progression to Alzheimer’s disease.
“Our clinical trial is aimed at individuals with mild cognitive changes, with the goal of slowing decline and delaying progression to dementia,” said Dr. Marilyn Albert, director of the Division of Cognitive Neuroscience at Johns Hopkins.
Called the HOPE4MCI Alzheimer’s Trial, the global, Phase 3 study is testing an FDA-approved epilepsy medication at a lower dose to see if it’s safe and effective for people with mild cognitive impairment. The drug’s generic name is levetiracetam, and it is sold under the brand names Roweepra, Spritam and Keppra.
Previous studies at NIH and Harvard Medical School have shown that people with Alzheimer’s have seizures and similar brain activity that may contribute to the loss of cognitive function; therefore, researchers want to see if an anti-seizure drug could have an effect on the progression of the disease.
“Our clinical trial is using a novel approach to treatment. We are using low doses of a drug that has been already been approved for a completely different disorder,” Albert said.
How the study works
In the randomized, double-blind trial, study participants will take either levetiracetam or a placebo every day for 18 months. Neither the participants nor the researchers will know who is taking which pill.
Every six months, they’ll receive a magnetic resonance imaging (MRI) scan, which takes less than an hour and does not involve radiation. MRIs will take place in downtown Baltimore at the medical school’s Division of Psychiatric Neuroimaging, located at 733 N. Broadway.
Albert’s team hopes to make progress in the fight against the disease, she said. “We have decided to take a different approach from the majority of the clinical trials that are currently underway.
“Since a new drug has not been approved for Alzheimer’s disease since 2003, we feel it is important to try something novel.”
All procedures are conducted at no charge to the patient, and compensation can total up to $700 for completing all study visits. In addition, free parking is provided. For those without cars, free transportation to and from Johns Hopkins is available.