📋 Research Plan
Alzheimer's diseaseAPOE$983,50018-24 monthsN = 300
Assay
Phase 2 RCT comparing APOE modulator vs. placebo in N=300 early AD patients, primary endpoint: change from baseline on composite cognitive score at 18 months. Sample size powered at 80% for effect size=0.38, alpha=0.05.
Primary endpoint
Composite cognitive score (ADAS-Cog13 + ADCS-ADL)
Kill criteria
- APOE4→APOE3 conversion shows no amyloid reduction in Phase 3 trial
- APOE isoform switching fails to improve cognitive endpoints at 18 months
- Lipid代谢 correction fails to modify disease progression in APOE4 carriers
Power: {'test': 'two-sided t-test', 'alpha': 0.05, 'power': 0.8, 'effect_size': 0.38}