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A 5-month, randomized, placebo-controlled trial of
galantamine in Alzheimer's Disease.
Tariot PN, Solomon PR, Morris JC, Kershaw P, Lilienfeld S, Ding C
Dept. of Psychiatry,
University of Rochester Medical Center, NY 14620
Neurology 2000 Jun 27;54(12):2269-76
ABSTRACT
OBJECTIVE: To investigate the efficacy and tolerability of galantamine,
using a slow dose escalation schedule of up to 8 weeks, in 978 patients with
mild to moderate AD.
METHODS: A 5-month multicenter,
placebo-controlled, double-blind trial. Following a 4-week placebo run-in,
patients were randomized to one of four treatment arms: placebo or galantamine
escalated to final maintenance doses of 8, 16, or 24 mg/day. Outcome measures
included the cognitive subscale of the AD Assessment Scale (ADAS-cog), the
Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC-plus),
the AD Cooperative Study Activities of Daily Living inventory, and the
Neuropsychiatric Inventory. Standard safety evaluations and adverse event
monitoring were carried out.
RESULTS: After 5 months, the
galantamine-placebo differences on ADAS-cog were 3.3 points for the 16 mg/day
group and 3.6 points for the 24 mg/day group (p < 0.001 versus placebo, both
doses). Compared with placebo, the galantamine 16- and 24-mg/day groups also had
a significantly better outcome on CIBIC-plus, activities of daily living, and
behavioral symptoms. Treatment discontinuations due to adverse events were low
in all galantamine groups (6 to 10%) and comparable with the discontinuation
rate in the placebo group (7%). The incidence of adverse events in the
galantamine groups, notably gastrointestinal symptoms, was low and most adverse
events were mild.
CONCLUSIONS: Galantamine 16 and 24
mg/day significantly benefits the cognitive, functional, and behavioral symptoms
of AD as compared with placebo. Slow dose escalation appears to enhance the
tolerability of galantamine, minimizing the incidence and severity of adverse
events.
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