Table of Contents
Mary Ganguli’s Slides
Mild Cognitive Impairment
FDA’s 5 Questions
What is the conceptual issue in question?
Clinical Characterization of MCI
A. Clinical Definition of MCI
1. Memory Complaint
2. Normal ADLs
3. Normal general cognitive function
4. Abnormal memory for age.
5. Not Demented
B. Validity of Clinical Criteria
Aspects of Validity
Face and Content Validity
Circularity vs Concurrent Validity
C. Differential Diagnosis of MCI
D. Appropriate Outcome Measures for MCI Drug Trials
Standard Features for MCI Trials
Additional Special Features for MCI Trials?
Know the Enemy