Page 2 - Drug Class Review

Final Report Update 1 Drug Effectiveness Review Project

TABLE OF CONTENTS

INTRODUCTION ..........................................................................................................................4
A. Overview..............................................................................................................................................4
B. Scope and key questions ....................................................................................................................8

METHODS..................................................................................................................................12
A. Literature search................................................................................................................................12
B. Study selection ..................................................................................................................................12
C. Data abstraction ................................................................................................................................14
D. Quality assessment...........................................................................................................................14

RESULTS ...................................................................................................................................16
Key Question 1. Efficacy/Effectiveness .................................................................................................18
A. Description of studies...................................................................................................................18
B. Study populations.........................................................................................................................18
C. Outcome measures......................................................................................................................19
D. Head-to-head comparisons..........................................................................................................19
E. Placebo-controlled trials...............................................................................................................21
F. Summary of the evidence.............................................................................................................27
Key Question 2. Time to Effect ..............................................................................................................33
Key Question 3. Adverse Events ...........................................................................................................35
A. Specific adverse events ...............................................................................................................37
B. Summary of the evidence ............................................................................................................40
Key Question 4. Subgroups...................................................................................................................42
A. Age ...............................................................................................................................................42
B. Race .............................................................................................................................................42
C. Sex ...............................................................................................................................................43
D. Parkinsonian features ..................................................................................................................43
E. Comorbid vascular dementia .......................................................................................................44
F. Other drugs...................................................................................................................................45
G. Summary of the evidence ............................................................................................................47
REFERENCES ...........................................................................................................................51

FIGURE
Figure 1: Results of literature search.....................................................................................................57
IN-TEXT TABLES
Table 1: Current drug treatments for Alzheimer’s disease ......................................................................7
Table 2: Outcome measures and study eligibility criteria ......................................................................10
Table 3: Abbreviations and full names of assessment scales and other instruments...........................17
Table 4: Summary of trials assessing symptoms and behavioral disturbances....................................29
Table 5: Mean incidence of specific adverse events in placebo-controlled trials..................................36
Table 6: Summary of trials assessing adverse events ..........................................................................41
Table 7: Summary of trials assessing subgroups..................................................................................48
Table 8: Key questions and summary of the evidence..........................................................................49
Table 9: Abbreviations for Evidence Tables ..........................................................................................59

EVIDENCE TABLES
Efficacy/Effectiveness............................................................................................................................61
Adverse Events....................................................................................................................................160
Subgroups............................................................................................................................................182
APPENDICES
Appendix A. Search Strategy...............................................................................................................195
Appendix B. Clinical Assessment Scales Commonly Used in AD Therapeutic Trials.........................197
Appendix C. Quality Criteria.................................................................................................................199

Alzheimer's Drugs Page 2 of 205