PMID- 11843990
OWN - NLM
STAT- MEDLINE
DCOM- 20020307
LR  - 20220317
IS  - 0002-8614 (Print)
IS  - 0002-8614 (Linking)
VI  - 49
IP  - 12
DP  - 2001 Dec
TI  - A randomized, double-blind, placebo-controlled study of the efficacy and safety 
      of donepezil in patients with Alzheimer's disease in the nursing home setting.
PG  - 1590-9
AB  - OBJECTIVES: To evaluate the safety and efficacy of donepezil in the management of 
      patients with Alzheimer's disease (AD) residing in nursing home facilities. 
      DESIGN: Twenty-four-week, randomized, multicenter, parallel-group, double-blind, 
      placebo-controlled trial. SETTING: Twenty-seven nursing homes across the United 
      States. PARTICIPANTS: Two hundred eight nursing home patients with a diagnosis of 
      probable or possible AD, or AD with cerebrovascular disease; mean Mini-Mental 
      State Examination (MMSE) score 14.4; mean age 85.7. MEASUREMENTS: The primary 
      outcome measure was the Neuropsychiatric Inventory-Nursing Home Version (NPI-NH). 
      Secondary efficacy measures were the Clinical Dementia Rating (Nursing Home 
      Version)-Sum of the Boxes (CDR-SB), MMSE, and the Physical Self-Maintenance Scale 
      (PSMS). Safety was monitored by physical examinations, vital signs, clinical 
      laboratory tests, electrocardiograms (ECGs), and treatment-emergent adverse 
      events (AEs). RESULTS: Eighty-two percent of donepezil- and 74% of 
      placebo-treated patients completed the trial. Eleven percent of donepezil- and 
      18% of placebo-treated patients withdrew because of AEs. Mean NPI-NH 12-item 
      total scores improved relative to baseline for both groups, with no significant 
      differences observed between the groups at any assessment. Mean change from 
      baseline CDR-SB total score improved significantly with donepezil compared with 
      placebo at Week 24 (P < .05). The change in CDR-SB total score was not influenced 
      by age. Differences in mean change from baseline on the MMSE favored donepezil 
      over placebo at Weeks 8, 16, and 20 (P < .05). No significant differences were 
      observed between the groups on the PSMS. Overall rates of occurrence and severity 
      of AEs were similar between the two groups (97% placebo, 96% donepezil). 
      Gastrointestinal AEs occurred more frequently in donepezil-treated patients. In 
      general, AEs were similar in older and younger donepezil-treated patients, with 
      the majority of patients experiencing only AEs that were transient and mild or 
      moderate in severity. Weight loss was reported as an AE more frequently in older 
      patients, although a loss at last visit of >or=7% of screening weight occurred at 
      the same rate in older and younger patients (9% of donepezil- and 6% of 
      placebo-treated patients). No significant differences between groups in vital 
      sign changes, bradycardia, or rates of clinically significant laboratory or ECG 
      abnormalities were observed. CONCLUSION: Patients treated with donepezil 
      maintained or improved in cognition and overall dementia severity in contrast to 
      placebo-treated patients who declined during the 6-month treatment period. The 
      safety and tolerability profile was comparable with that reported in outpatient 
      studies of donepezil. These findings also suggest that advanced age, comorbid 
      illnesses, and high concomitant medication usage should not be barriers to 
      donepezil treatment. Given the apparent improvement in behavior in the placebo 
      group, and the high use of concomitant medications in both groups, the impact of 
      donepezil on behavior in the nursing home setting is unresolved and merits 
      further investigation. In summary, effects on cognition, overall dementia 
      severity, and safety and tolerability findings are consistent with previous 
      findings in outpatients and support the use of donepezil in patients with AD who 
      reside in nursing homes.
FAU - Tariot, P N
AU  - Tariot PN
AD  - Department of Psychiatry, University of Rochester Medical Center, Monroe 
      Community Hospital, Rochester, New York 14620, USA.
FAU - Cummings, J L
AU  - Cummings JL
FAU - Katz, I R
AU  - Katz IR
FAU - Mintzer, J
AU  - Mintzer J
FAU - Perdomo, C A
AU  - Perdomo CA
FAU - Schwam, E M
AU  - Schwam EM
FAU - Whalen, E
AU  - Whalen E
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Am Geriatr Soc
JT  - Journal of the American Geriatrics Society
JID - 7503062
RN  - 0 (Cholinesterase Inhibitors)
RN  - 0 (Indans)
RN  - 0 (Piperidines)
RN  - 8SSC91326P (Donepezil)
SB  - IM
CIN - J Am Geriatr Soc. 2003 Jan;51(1):132; author reply 132-3. PMID: 12534859
CIN - J Am Geriatr Soc. 2003 Jan;51(1):133-4; author reply 134. PMID: 12534861
MH  - Aged
MH  - Aged, 80 and over
MH  - Alzheimer Disease/*drug therapy/physiopathology/psychology
MH  - Cholinesterase Inhibitors/*adverse effects/*therapeutic use
MH  - Cognition/*physiology
MH  - Donepezil
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Indans/*adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Neuropsychological Tests
MH  - *Nursing Homes
MH  - Outcome Assessment, Health Care
MH  - Piperidines/*adverse effects/*therapeutic use
MH  - Psychiatric Status Rating Scales
MH  - Severity of Illness Index
EDAT- 2002/02/15 10:00
MHDA- 2002/03/08 10:01
CRDT- 2002/02/15 10:00
PHST- 2002/02/15 10:00 [pubmed]
PHST- 2002/03/08 10:01 [medline]
PHST- 2002/02/15 10:00 [entrez]
AID - 49266 [pii]
PST - ppublish
SO  - J Am Geriatr Soc. 2001 Dec;49(12):1590-9.