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Screening metrics for Alzheimer's disease psychosis (ADP) are being developed using biomarker data. This study highlights the need for biological criteria in diagnosing AD, especially in patients with psychosis.

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Area of Science:

  • Neurology
  • Biomarkers
  • Clinical Trials

Background:

  • Alzheimer's disease (AD) diagnosis relies on biomarkers, but data are limited in patients with psychosis and cognitive decline.
  • This study addresses sparse biomarker data in patients diagnosed with AD and psychosis using established criteria.
  • Patients were enrolled in the ACP-204 Alzheimer's disease psychosis (ADP) clinical development program, investigating ACP-204, a serotonin 2A receptor antagonist.

Purpose of the Study:

  • To present screening metrics based on study biomarker requirements for patients with AD and psychosis.
  • To evaluate the utility of plasma biomarkers (APS, APS2, p-tau217) in predicting amyloid brain status.
  • To inform the design of future clinical trials for ACP-204 in ADP.

Main Methods:

  • Patients were screened for Part 1 of the ACP-204-006 master protocol, including phase 2 and phase 3 studies.
  • Clinical criteria for AD (NIA-AA) and psychosis (IPA) were applied, alongside confirmed plasma or historical biomarker positivity.
  • Blood samples were analyzed for Amyloid Probability Score (APS), APS2, and phosphorylated tau at threonine 217 (p-tau217) ratio using commercial blood tests and diagnostic algorithms.

Main Results:

  • Between February and December 2024, 322 adults were screened; 75 met NIA-AA and IPA criteria.
  • Of those meeting clinical criteria for ADP, 23 did not have APS or APS2 positivity despite meeting historical biomarker requirements.
  • Detailed biomarker results, including apoE proteotype, Aβ42/40 ratio, and p-tau217 ratio, will be presented for the screened population.

Conclusions:

  • Biomarkers are recommended for the biological definition of AD over syndromic presentation.
  • Sparse biomarker data in patients with AD dementia and psychosis necessitates presenting data from a rigorously phenotyped population.
  • Findings will aid in the design and execution of future clinical trials for Alzheimer's disease psychosis.