Acumen Pharmaceuticals’ Phase 2 Advancements in Alzheimer Disease Screening: Todd Feaster, PsyD

WATCH TIME: 5 minutes

"We're reducing the burden on sites, patients, and sponsors by sparing unnecessary PET scans and lumbar punctures."

Several Alzheimer disease (AD) trials screen and exclude a substantial number of potential patients who do not meet study criteria relating to amyloid pathology consistent with AD. The phase 2 ALTITUDE-AD (NCT06335173) trial is an 80-week, global, randomized, double-blind, placebo-controlled, multi-site study of sabirnetug (Acumen Pharmaceuticals) in patients with early AD and evidence of amyloid pathology. The screening occurs in 2 parts, with the first screening part being a blood test using the Fujirebio plasma p-tau217 assay. Then, patients with p-tau217 concentrations of at least 0.15 pg/mL are eligible for the second screening part, which is a confirmatory test of amyloid pathology.

New data presented from the ongoing trial showed that more than half of potential study participants were excluded because of a plasma p-tau217 test result less than 0.15 pg/mL.^1,2 Authors noted that participants who proceeded to amyloid positron emission tomography (PET) or cerebrospinal fluid (CSF) Aβ42/40 were enriched for meeting amyloid-based inclusion criteria. Therefore, the p-tau217 enrichment strategy appeared to be performing as intended, reducing unnecessary amyloid PET scans or LP procedures for potential clinical trial participants compared with previous methods.

These new results were presented at the 2024 Clinical Trials on Alzheimer’s Disease (CTAD) conference, held October 29 to November 1, in Madrid, Spain, by lead author Todd Feaster, PsyD, the senior clinical research scientist at Acumen Pharmaceuticals. Following the presentation, Feaster sat down with NeurologyLive^® to speak about how the implementation of the plasma p-tau 217 biomarker impacted screen failure rates in the company's phase 2 trial for patients with AD. He also talked about the main limitations identified in using plasma biomarkers in global studies, particularly in regions without CE marking. Furthermore, Feaster discussed how advancements in blood-based biomarkers might shape the future of AD diagnosis.

Click here for more coverage of CTAD 2024.

REFERENCES
1. Feaster T, et al. ALTITUDE-AD: Use of a Validated p-tau217 Assay to Screen Potential Participants in an Ongoing Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Sabirnetug for Participants with Early Alzheimer's Disease. Presented at: 2024 CTAD; October 29-November 1; Madrid, Spain. LB11.
2. Acumen Pharmaceuticals to Deliver Late-Breaking Presentation at 17th Annual Clinical Trials on Alzheimer’s Disease (CTAD) Conference. News Release. Acumen Pharmaceuticals. Published October 23, 2024. Accessed October 31, 2024. https://investors.acumenpharm.com/news-releases/news-release-details/acumen-pharmaceuticals-deliver-late-breaking-presentation-17th