EnVivo Pharmaceuticals Inc.’s pill designed to stimulate the same brain receptors as nicotine helped improve memory in Alzheimer’s patients after 23 weeks, an early trial showed.
Patients given the drug at the highest dose improved on two measures of memory, according to data presented today at the Alzheimer’s Association International Conference in Vancouver. The subjects, who had mild to moderate disease, improved whether or not they were taking another Alzheimer’s medication.
EnVivo’s drug targets the nicotinic A7 receptors, which are located in parts of the brain that help control learning. Like nicotine, the medicine activates the processes that boost learning and memory, without nicotine’s side-effects. Previous studies have suggested nicotine can enhance cognitive functions.
“This is promising and has potential,” said Laurie Ryan, the program director for Alzheimer’s disease clinical trials at the National Institute on Aging in Bethesda, Maryland. The effect needs to be replicated in larger, later-stage trials, she said. “We’ve been talking a lot about pre-symptomatic trials, but we still need treatments for people with the full disease.”
Alzheimer’s may affect 16 million Americans by 2050, an increase from 5.4 million now, according to U.S. health officials. While efforts are under way to delay or prevent the disease, people already diagnosed will need therapies to help them with the activities of daily living, Ryan said.
EnVivo, based in Watertown, Massachusetts, tested more than 400 people, in four groups: with a placebo, a 0.3-milligram pill, a 1-milligram dose and a 2-milligram quantity. The 2- milligram dose had significant benefits over the placebo on two measures of thinking ability. The trial was the second of three phases typically required for U.S. regulatory approval.
The closely held company is examining its options for Phase 3 trials, said Kees Been, chief executive officer of EnVivo. Though EnVivo wants to commercialize the drugs, the company will need a partner, Been said in an interview.
“The world is very large, and too big for us on our own,” Been said.
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