Long-term efficacy of olanzapine in the control of psychotic and behavioral symptoms in nursing home patients with Alzheimer's dementia.
BACKGROUND
Psychotic symptoms and behavioral disturbances are a leading cause of institutionalization in elderly patients with Alzheimer's disease (AD).


OBJECTIVE
Elderly nursing home patients (n=105) with possible or probable AD were entered into a multicenter study to determine the long-term efficacy and safety of olanzapine in treatment of psychotic symptoms and behavioral disturbances due to AD.


METHODS
Following a double-blind, 6-week exposure to fixed-dose olanzapine (5, 10, or 15 mg/d), patients entered an additional 18-week, open-label, flexible-dose treatment. Baseline was defined from the start of the extension phase.


RESULTS
Patients improved significantly on the primary efficacy measure, defined a priori, which consisted of the sum of the Agitation/Aggression, Delusions, and Hallucinations items ('Core':) of the NPI/NH. Olanzapine also significantly improved scores for the NPI/NH total and the Core item-associated Occupational Disruptiveness of the NPI/NH, as well as the BPRS total and CGI Severity-of-Alzheimer's scores. Barnes Akathasia scores improved significantly from baseline, while Simpson-Angus and AIMS scores were not significantly changed. Treatment-emergent symptoms included somnolence, accidental injury, and rash. No significant changes were seen in ECGs, including QT(c) interval, nor in weight or vital signs, including orthostasis.


CONCLUSIONS
Low-dose olanzapine appears to be effective and well tolerated for treatment of behavioral disturbances and psychotic symptoms due to AD in elderly patients.
Street
J S
JS
Lilly Research Laboratories, Indianapolis, IN 46285, USA.
Clark
W S
WS
Kadam
D L
DL
Mitan
S J
SJ
Juliar
B E
BE
Feldman
P D
PD
Breier
A
A
D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D001526:Behavioral Symptoms / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D001569:Benzodiazepines; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006707:Homes for the Aged; D006801:Humans; D008134:Long-Term Care; D008297:Male; D009483:Neuropsychological Tests; D009735:Nursing Homes; D000077152:Olanzapine; D010890:Pirenzepine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D011618:Psychotic Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D016896:Treatment Outcome
D001569:Benzodiazepines; D010890:Pirenzepine; D000077152:Olanzapine