Tetra Therapeutics reports that its Phase II PICASSO AD clinical trial for Alzheimer’s disease (AD) reveals it has surpassed 50% enrollment with 65% of the participants being Hispanic since the initiation of the trial in May. The wave of clinical trials and therapeutic area educational campaigns in communities across the U.S. appears to be having an impact.
The PICASSO AD study is a randomized, double-blind, placebo-controlled, 3-arm parallel design study to evaluate the effects of BPN 14770 in patients with early Alzheimer’s disease. The study sponsor is seeking 255 patients. Initiated May 10, 2019, the trial lasts for three months at up to 60 sites across the nation. Of the 255 targeted patient participants, 142 have been enrolled. Enrollment is about 3.5 months ahead of scheduled and the study is expected to be completed by early 2020 with topline results by mid-2020 reports the Valdosta Daily Times.
What is BPN14770
BPN14770, a novel agent that selectively inhibits phosphodiesterase-4D (PDE4D), is designed to enhance the early and late stages of memory formation and to potentially improve cognition and memory in patients with AD. Preclinical research revealed that the investigational product to trigger multiple compensatory mechanisms in the brain that in a humanized mouse model of amyloid beta1-42 neurotoxicity reduced memory impairment, damage to neuronal morphology, deficits in synaptic proteins and impaired neurological signaling. BPN14770 is currently approved for investigational use only.
Consequently, Tetra is presently conducting an investigational Phase II study of BPN14770 in adults with early AD and a second investigational Phase II study in adults with Fragile X Syndrome, an indication for which BPN14770 has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA). Tetra raised $29 million in government grants in addition to $40 million in a Series B and collaboration with Japan-based Shionogi & Co., Ltd. Based in Michigan, Tetra was founded as Tetra Discovery Partners in 2011 to develop a portfolio of therapeutics aimed at treating cognitive impairment and memory loss by improving how the brain processes and stores information reported CEO Mark Gurney.
Alzheimer’s & Diversity
The Centers for Disease Control and Prevention reports that among individuals 65 and older, Hispanics have the second-highest prevalence of Alzheimer’s disease and related dementias (12.2%) behind African Americas (13.8%) and ahead of non-Hispanic whites (10.3%). By 2060 researchers estimate that over 3.2 million Hispanics will face AD and related dementias.
Participating in Clinical Investigative Site in Miami
In fact, Ernesto Diaz, Principal Investigator at Linfritz Research Center, Miami FL, reports “Data suggests that the Hispanic population may be at greater risk to develop Alzheimer’s disease and dementia than other groups and nearly 70% of Miami’s population is Hispanic.”
“Our clinic is pleased to participate in this clinical trial of a novel treatment being evaluated to or potentially restore or improve cognition and memory in patients with an early diagnosis of Alzheimer’s disease.”
Hispanic Alzheimer’s Patient Group
Jason Resendez with LatinosAgainstAlzheimer’s, a coalition convened by UsAgainstAlzheimer’s noted: “By 2030, nearly 40% of Americans living with Alzheimer’s will be Latino or African American and our healthcare system is woefully unprepared for this shift.” “Given the increased risk of Alzheimer’s among Latinos, it is absolutely critical that we promote diversity and inclusion in Alzheimer’s research, care, and treatment.”
Ernesto Diaz, Principal Investigator, Linfritz Research Center
Call to Action: Do you or a loved one have an Alzheimer’s disease diagnosis in the family? Consider the PICASSO AD study. Interested in tracking the results of PICASSO AD sign up for the TrialSite Newsletter.