Page 330 - Drug Class Review
P. 330
Final Report Update 1 Drug Effectiveness Review Project
APPENDIX B. Clinical Assessment Scales Commonly Used in AD
Therapeutic Trials
Domain / Scale Description
Cognition Memory, orientation, language, praxis, etc.
Mini-Mental State Exam (MMSE) 30-pt. scale (higher scores better)
Clinician administered patient evaluation
Mostly used for eligibility screening and dementia staging
Alzheimer’s Disease Assessment 70-pt. scale (higher scores worse)
Scale-cognitive subscale (ADAS- Clinician administered patient evaluation
cog) Standard cognitive outcome measure in mild-moderate AD
Severe Impairment Battery (SIB) 100-pt. scale (higher scores better)
Clinician administered patient evaluation
Cognitive outcome measure used in moderate-severe AD
Global Change Summary outcome assessment from baseline to endpoint
Clinical Global Impression of 7-pt. scale (1 = very much improved, 4 = no change, 7 =
Change (CGI-C) very much worse)
Clinician rated, based on patient +/- informant interview
Clinician’s Interview-Based 7-pt. scale (1 = very much improved, 4 = no change, 7 =
Impression of Change Plus very much worse)
Caregiver Input (CIBIC-Plus) Clinician rated (with caregiver input), based on semi-
structured interview covering cognition, behavior, function
Global Deterioration Scale (GDS) 7-pt. scale (1 = no decline, 7 = very severe decline)
Clinician rated based on cognitive change only
Alzheimer's Drugs Page 197 of 205
