The drug, which is a serotonin 4 (5-HT4) receptor agonist, was also well-tolerated in the trial. The company now expects to initiate a phase II dose-ranging trial in Alzheimer’s disease patients early next year.
“The results of this phase Ib trial in patients with Alzheimer’s disease suggest that PRX-03140 is stimulating the 5-HT4 receptor in the brain and is eliciting the desired effects on brain waves consistent with approved drugs for Alzheimer’s disease,” said Dr Stephen Donahue, vice president of clinical and regulatory affairs.
In the study patients with mild-to-moderate Alzheimer’s disease received a once-daily dose of PRX-03140 or placebo for 14 days.
The trial assessed the effects of the drug on quantitative electroencephalograms (EEGs), a measure of the electrical activity in the brain that has been used to characterize the effects of drugs that act on the central nervous system.
In Alzheimer’s disease patients, a specific EEG slow wave pattern has been linked with severity of dementia. With PRX-03140 treatment of Alzheimer’s disease patients, there was a statistically significant improvement in the quantitative EEG slow wave pattern when compared with placebo.
The short-term EEG effects observed with PRX-03140 treatment are similar to the published effects seen in patients that have an improvement in cognitive function after months of treatment with approved acetylcholinesterase inhibitor therapies for Alzheimer’s disease.