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. Author manuscript; available in PMC: 2021 Jan 6.
Published in final edited form as: Alzheimers Dement. 2020 Jan 6;16(1):131–143. doi: 10.1016/j.jalz.2019.06.4956

Table 2a:

Draft FDA Guidance for Approvals in Presymptomatic/Early AD

Stage 1 Stage 2 Stage 3 Stage 4
Preclinical Prodromal (MCI) Early AD Mild-moderate AD
Definition

  • Asymptomatic

  • Biomarker evidence of pathology (only)

  • Detectable cognitive changes

  • No functional impairment

  • Cognitive impairment

  • Mild functional impairment

  • Overt dementia

  • Cognitive and functional impairment
Possible endpoints

  • Biomarker

  • Imaging

 Cognitive scale(s) only (biomarker supported dx) Clinical scale(s) to assess both daily function and cognitive effects Clinical scale(s) to assess both daily function and cognitive effects
Clinically meaningful effect for approval? Not required Clinically meaningful ideal; not required Clinically meaningful effect required Clinically meaningful effect required
Approval type Conditional approval Conditional approval Regular approval Regular approval