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Basic Science and Pathogenesis.

Christopher T Brown1, Jessica Enos1, Carolyn Langlois1

  • 1Banner Alzheimer's Institute, Phoenix, AZ, USA.

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Summary
This summary is machine-generated.

The Alzheimer's Prevention Initiative Generation studies evaluated treatments for Alzheimer's disease but were stopped early due to reversible cognitive worsening. Data and samples are available for future Alzheimer's prevention research.

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Area of Science:

  • Neuroscience
  • Clinical Trials
  • Biomarker Research

Background:

  • The Alzheimer's Prevention Initiative (API) Generation Program conducted two studies (NCT0256551, NCT03131453) sponsored by Novartis and Amgen.
  • Studies focused on cognitively unimpaired individuals aged 60-75 with APOE4 variants, assessing beta-secretase (BACE1) inhibitor umibecestat and amyloid beta immunotherapy CAD106.
  • Participants were screened for cognitive status, clinical presentation, and brain amyloid levels.

Purpose of the Study:

  • To evaluate the cognitive, clinical, and biomarker effects of umibecestat and CAD106 in APOE4 carriers.
  • To investigate early biological and cognitive changes associated with Alzheimer's disease predisposition.
  • To inform the design of future Alzheimer's prevention trials.

Main Methods:

  • Recruitment occurred across 120 international trial sites.
  • Comprehensive assessments included clinical evaluations, brain imaging, and cerebrospinal fluid collection.
  • RNA, DNA, plasma, serum, and CSF samples were collected for analysis.

Main Results:

  • Studies were prematurely discontinued due to mild, reversible cognitive worsening observed in participants treated with umibecestat.
  • Screening data from 10,000 volunteers and treatment epoch data from 2,881 APOE4 carriers were collected.
  • Extensive biomaterial aliquots (RNA, DNA, plasma, serum, CSF) are available for sharing.

Conclusions:

  • The API Generation Program provides valuable data and biological samples for Alzheimer's research.
  • Researchers can assess early disease changes and treatment effects in APOE4 carriers.
  • Available resources can guide the development of future Alzheimer's prevention strategies.