(RxWiki News) There are few medications currently approved to treat Alzheimer’s disease (AD). A new type of drug shows early promise in clinical trials.
At a recent conference, Envivo Pharmaceuticals reported that their new drug improved cognition in patients with AD.
The company is seeking approval for the drug from the Food and Drug Administration (FDA) and still has more trials to complete, but the early results are promising.
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The new drug from Envivo Pharmaceuticals, currently called EVP-6124, has been in clinical trials to discover its safety and effectiveness.
The conference presentation, led by Dana Hilt, MD, of Envivo Pharmaceuticals, disclosed the results of their Phase 2 FDA trial.
In the trial, 409 people with mild to moderate AD were enrolled. The patients were either stable on another therapy for AD, like Aricept, or were not currently taking any medication for AD.
Some participants received the new drug and some received a placebo pill for six months. Patients were given multiple standard measures for memory and cognition that are commonly used in dementia research.
The trial found that patients taking EVP-6124 showed improvement in their cognition on standardized tests, while the placebo group did not show test score improvements.
The most common side effects of EVP-6124 were gastrointestinal.
Dr. Hilt said, in a recent conference press release, “"In our study, EVP-6124 provided significant benefits for people with mild to moderate Alzheimer's whether they were on currently approved therapy or not."
However, the study did not report any changes in global functioning or quality of life, so it is unclear if the improved scores on the cognitive tests reflect improvements in daily life functions.
These results are a product of Phase 2 clinical trials of this experimental medication. EVP-6124 is not currently approved by FDA and must undergo further testing in Phase 3 trials for safety and efficacy.
EVP-6124 is a nicotinic receptor agonist, meaning it increases activity of a type of receptor that normally responds to acetylcholine. Aricept, a currently approved AD medication, also has actions on the acetylcholine system through a different mechanism.
This study was presented July 18 at the Alzheimer’s Association International Conference in Vancouver, Canada.
Because this study was presented at a conference, it may not have been reviewed by other experts in the field.