Design of Clinical Studies of Pharmacologic Therapies for Alzheimer’s Disease

The Green Park Collaborative – International developed an Evidence Guidance Document (EGD) on Alzheimer’s disease in order to test an international process for developing disease-specific guidance on the design of clinical studies to meet the needs of payers and health technology assessment bodies. The collaborative also produced an evaluation of that pilot project that explores the challenges and opportunities of international collaboration on such guidance.

The guidance provides recommendations regarding the selection criteria, interventions, comparators, outcomes, and follow-up employed in phase 3 and 4 trials of pharmaceutical therapies intended for use in patients with mild or moderate Alzheimer’s disease.

EGD:  Design of Clinical Studies of Pharmacologic Therapies for Alzheimer’s Disease

Evaluation Report:  Green Park Collaborative Evaluation Report – Pilot Phase