Tetra Launches Phase 2 Trial Testing Treatment to Improve Working Memory in Older Patients

Tetra Launches Phase 2 Trial Testing Treatment to Improve Working Memory in Older Patients
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 param
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