Acumen Pharmaceuticals is employing a validated research-use plasma pTau217 assay to screen potential participants in its ongoing Phase 2 ALTITUDE-AD clinical trial of sabirnetug (ACU193) for early Alzheimer's disease. The company will present updated data on this screening approach at the 17th Annual Clinical Trials on Alzheimer’s Disease (CTAD) conference in Madrid, Spain.
pTau217 Assay as a Screening Tool
Phosphorylated tau at position 217 (pTau217) is a biomarker indicative of Alzheimer's disease pathology. The plasma pTau217 assay serves as an initial screening tool to identify individuals who qualify for further amyloid testing, which determines their eligibility for the ALTITUDE-AD trial. This approach aims to enrich the trial population with individuals who are more likely to benefit from sabirnetug.
Sabirnetug (ACU193): Targeting Soluble Amyloid Beta Oligomers
Sabirnetug is a humanized monoclonal antibody specifically designed to target soluble amyloid beta oligomers (AβOs), which are considered highly toxic and pathogenic forms of Aβ. These oligomers have been shown to bind to neurons, inhibit synaptic function, and induce neurodegeneration. By selectively targeting soluble AβOs, sabirnetug aims to address the underlying cause of neurodegeneration in Alzheimer's disease. The U.S. Food and Drug Administration has granted Fast Track designation to sabirnetug for the treatment of early Alzheimer's disease.
ALTITUDE-AD Trial Details
ALTITUDE-AD is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial initiated in 2024. It is designed to evaluate the efficacy and safety of sabirnetug infusions, administered once every four weeks, in slowing cognitive and functional decline compared to placebo in participants with early Alzheimer's disease. The study plans to enroll approximately 540 individuals with early Alzheimer's disease (mild cognitive impairment or mild dementia due to AD). The trial is ongoing at multiple sites in the United States, Canada, the UK, and the European Union (NCT06335173).
Alzheimer's Disease Context
Alzheimer's disease affects millions worldwide, with a significant unmet need for effective therapies that can modify the course of the disease. Current treatments primarily address symptoms, but do not halt or reverse the underlying neurodegenerative process. The focus on targeting soluble amyloid beta oligomers represents a promising approach to address the disease's root cause.
