Mary Ganguli’s Slides

3/16/01


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Table of Contents

Mary Ganguli’s Slides

Mild Cognitive Impairment

FDA’s 5 Questions

Additional 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

Concurrent Validity

Circularity vs Concurrent Validity

Predictive Validity

“Conversion”

Potential Interpretations

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

Author: Mary Ganguli