Tetra Discovery Partners is launching a Phase 2 clinical trial for BPN14770 — found to improve working memory in older patients in earlier trials — as a treatment for people with early stage Alzheimer’s disease.
The trial, called PICASSO AD (NCT03817684), is recruiting in about 60 clinical sites in the U.S., and expects to enroll approximately 255 participants, ages 55 to 85, with early Alzheimer’s.
Participants will be randomly selected to receive one of two different oral doses of BPN14770 (10 mg or 25 mg) or a placebo (control group), to be taken twice a day.
The trial’s main goal is to evaluate changes in patients’ memory from before treatment to after 3 months of therapy, using the standard clinical memory test Repeatable Battery for the Assessment of Neurological Status-Delayed Memory Index (RBANS-DMI).
Researchers also will measure changes in other memory, cognition, and daily function tests, including the Mini-Mental State Examination and the Alzheimer’s Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL).
Tetra’s decision to advance BPN14770 into a Phase 2 study was supported by the successful results of previous Phase 1 clinical trials, including a single ascending dose study in healthy subjects (NCT02648672). That was followed by a study (NCT02840279) testing multiple ascending doses of BPN14770 versus a placebo in healthy young and elderly (age 60 and older) volunteers.
The follow-up study found significant improvement in measures of working memory in participants ages 60 and older.
The results of a post-hoc analysis from the older volunteers showed that BPN14770, given at doses of 10 mg or 20 mg twice a day, could effectively improve working memory. No detectable effects were seen in other cognitive parameters, but the research was limited by the small number of participants, the researchers said.
“Results of previous Phase 1 studies with BPN14770 in healthy elderly volunteers suggested cognitive benefit, as observed in two different tests of working (immediate) memory,” Mark Gurney, PhD, chairman and CEO of Tetra Discovery Partners, said in a press release.
“We are eager to expand our studies of BPN14770 to the growing population of patients diagnosed with early Alzheimer’s disease, where a drug that is successful in restoring or improving memory function could offer enormous benefit,” he added.
BPN14770 is a negative modulator of the enzyme phosphodiesterase 4D (PDE4D), designed to both improve memory and slow Alzheimer’s disease progression. Research has shown that the brain neuronal PDE4D regulated the formation of new connections between neurons, and plays a critical role in learning processing and memory storage. The part of the brain responsible for working memory also is responsible for focus and concentration.
“Recent estimates cite Alzheimer’s disease as the 6th leading cause of death in the United States, and the only one with no effective means to prevent, cure, or slow its progression. This disease has an overwhelming impact not only on those diagnosed with the condition, but on families, caregivers, and the health care system,” said Paul Stephen Aisen, MD, professor of Neurology and director of the Alzheimer’s Therapeutic Research Institute, Keck School of Medicine, of the University of Southern California (USC).
“We are excited to see agents with novel mechanisms of action expand into a patient population in need of new treatments aimed at improving the devastating symptoms of the disease,” Aisen added.
For more information about PICASSO AD trial, including locations and contacts, visit its registry page here.
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