📋 Research Plan
Alzheimer's diseaseBDNF$967,00018-24 monthsN = 300
Assay
Phase 2 RCT comparing BDNF 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=0.32, alpha=0.05.
Primary endpoint
Composite cognitive score (ADAS-Cog13 + ADCS-ADL)
Kill criteria
- BDNF upregulation fails to improve hippocampal-cortical connectivity in MCI patients
- CA3-CA1 synaptic rescue does not translate to behavioral improvement in AD patients
- TrkB agonist shows no disease-modifying effect in 12-month trial
Power: {'test': 'two-sided t-test', 'alpha': 0.05, 'power': 0.8, 'effect_size': 0.32}