Donepezil and Memantine
for Moderate-to-Severe Alzheimer’s Disease
N Engl J Med 2012;366:893-903.
multicenter, double-blind, placebo-controlled, clinical trial
Patients
community residents who had caregivers who either lived with them or visited them at least daily.
Eligible participants met standardized clini- cal criteria15 for probable or possible moderate or severe Alzheimer’s disease, had been prescribed donepezil continuously for at least 3 months and had received a dose of 10 mg for at least the previous 6 weeks, and had a score between 5 and 13 on the Standardized Mini–Mental State Examination
既にドネペジルを内服している中等度以上のAD型認知症患者がentry.
Patients were excluded if they had severe or unstable medical conditions, were receiving memantine, or were considered to be unlikely to adhere to the study regimens.
メマンチンを既に内服している患者などは除外．
Intervention
4群に分ける．
ドネペジル継続群
すべて中止群
メマンチンへ変更群
ドネペジル・メマンチン併用群
割り付け
最小化法を使っている．appendixを読んでいないので分からないが理由の記載はなし．
この試験にふさわしい割り付け法なのか，かなり疑わしい．
patients, caregivers, clinicians, outcome assessors, and investigators were unaware of the treatment assignments
目隠しはされている．
characteristics
baselineに差はなし．
３例脱落あるが，ITTという記載．
Results
総じて，ドネペジルはすこーしだけ効果があるかという程度．
これをどれ程，臨床的に意義があると考えるか．
副作用は一応，差はなし．
ドネペジル600円/日，219,000円/年，メマリー 440円/日，160,600円/年
積極的に使いたい薬ではない．