Core Insights - Acumen Pharmaceuticals presented updated data on the pTau217 assay, highlighting its effectiveness in screening participants for the ALTITUDE-AD clinical trial, which reduces unnecessary amyloid PET scans and lumbar punctures for ineligible individuals [1][2][4] Company Overview - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies targeting soluble amyloid beta oligomers (AβOs) for Alzheimer's disease [9] - The company is headquartered in Newton, Massachusetts, and is advancing its investigational product candidate, sabirnetug (ACU193), in the ongoing Phase 2 clinical trial ALTITUDE-AD [9] Clinical Trial Details - ALTITUDE-AD is a Phase 2, multi-center, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of sabirnetug in approximately 540 adults aged 50 to 90 years [2][8] - The trial is currently enrolling participants at 75 sites across the U.S., Canada, EU, and U.K., with expected completion of enrollment in the first half of 2025 [2][8] pTau217 Assay Insights - The pTau217 assay serves as an enrichment tool, classifying participants most likely to be eligible for the ALTITUDE-AD study, with a threshold established at ≥0.15 pg/mL [4] - More than half of potential participants have been excluded due to pTau217 results below this threshold, while 74% of those with results ≥0.15 pg/mL met eligibility requirements following confirmatory assessments [4] Clinical Trial Process Improvement - The pTau217 screening assay is designed to reduce the burden on patients by minimizing invasive procedures and unnecessary radiation exposure, thus streamlining the trial enrollment process [2][3] - The study's design aims to enhance the patient experience while advancing next-generation treatments for Alzheimer's disease [5]
Acumen Pharmaceuticals Presents Innovative Trial Screening Advancements Utilizing pTau217 Assay in Phase 2 Study of Sabirnetug for Early Alzheimer's Disease at the 17th Annual Clinical Trials on Alzheimer's Disease Conference