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A phase 2 clinical trial has begun for a novel phosphodiesterase-4D (PDE4D) inhibitor, BPN14770 (Tetra Discovery Partners, Grand Rapids, MI)for potential improvement of improve cognition and memory in people with early Alzheimer’s disease (AD).
The PICASSO AD trial (NCT03817684) is a 3-month, randomized, placebo-controlled study that will be conducted at 60 sites across the US. The trial will enroll approximately 255 patients, age 55 to 85, with a clinical diagnosis of early AD, and will consist of 3 parallel study arms to evaluate twice-daily doses of BPN14770 vs placebo.
The primary endpoint for the trial will be the change from baseline scores in the Repeatable Battery for Assessment of Neurological Status—Delayed Memory Index (RBANS-DMI). Secondary endpoints will include changes from baseline in other standardized tests and clinical assessments of memory, cognition, and daily function, as well as pharmacokinetic measurements.
“Results of previous phase 1 studies with BPN14770 in healthy elderly volunteers suggested cognitive benefit, as observed in 2 different tests of working memory,” said Mark Gurney, PhD, chairman and chief executive officer, Tetra Discovery Partners. “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.”Preclinical animal models showed that BPN14770 has the potential to promote maturation of connections between neurons, which is impaired in patients with Fragile X Syndrome, and to protect connections that become lost in patients with AD.
Brian E. McGeeney, MD, MPH, MBA
Bob Azelby, MBA
Katharine Nicholson, MD