Page 10 - Drug Class Review

Final Report Update 1 Drug Effectiveness Review Project

Table 2: Outcome measures and study eligibility criteria

Outcome Outcome Measures Study Eligibility Criteria

• Stabilizing or slowing the rate of decline in • Head-to-head randomized controlled
health outcome measures: clinical trials or meta-analyses
- Activities of daily living comparing one AD drug to another
- Instrumental activities of daily living
- Level of care changes • When sufficient evidence was not
- Quality of life available for head-to-head
- Behavioral symptoms (e.g., aggression, comparisons we evaluated placebo-
agitation, psychosis, mood disorders) controlled trials

• Stabilizing or slowing the rate of decline in • Observational studies were reviewed
intermediate outcome measures: for hospitalizations, an outcome
Efficacy / - Cognition measure rarely assessed in controlled
Effectiveness - Global assessment trials for AD

• Discontinuation effects (i.e., temporary or
permanent changes in behavioral
symptoms, functional capacity, or cognition
as a result of discontinuing treatment)

• Reducing caregiver burden

• Hospitalizations or nursing home placement

• Mortality

• Overall adverse effect reports • Head-to-head randomized controlled
clinical trials or meta-analyses
• Withdrawals because of adverse effects comparing one AD drug to another

• Serious adverse event reports • When sufficient evidence was not
Safety/ available for head-to-head trials, we
Tolerability • Adverse events due to discontinuation evaluated:
• placebo-controlled trials
• Specific adverse events, including: • observational studies
- Gastrointestinal symptoms
- Hepatotoxicity
- Weight loss

AD – Alzheimer’s Disease

Given the progressive nature of AD it is important to note the distinction between clinical improvement

and slowing the progression of disease. Although a treatment may not demonstrate clinical improvement
from baseline over time, it may be able to slow the rate of cognitive or behavioral deterioration. In this
review we use the term “improvement” to reflect the degree to which patients improve with respect to

their comparator. Because most of the evidence for these drugs stems from placebo-controlled trials,
“improvement” commonly reflects differences between active- and placebo-treated patients. These

Alzheimer's Drugs Page 10 of 205