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Major Gains In Alzheimer's Treatment With Galantamine

Galantamine appears effective and well tolerated in patients with mild to moderate Alzheimer's disease and produces significant improvement in their daily activities.

A randomised, double-blind, parallel-group, placebo-controlled trial enrolled 653 patients from 86 out-patient clinics in Europe and Canada. Trial director was Dr Gordon Wilcock, Department of Care For the Elderly, Bristol University, England.

Galantamine is a new drug that reversibly and competitively inhibits acetylcholinesterase and enhances the response of nicotinic receptors to acetylcholine.

Trial patients randomly assigned to galantamine had their daily dose escalated over three to four weeks to maintenance doses of 24 mg or 32 mg.

Main outcome measures were scores on the 11 item cognitive subscale of the Alzheimer's disease assessment scale; the clinician's interview-based impression of change; assessments by caregivers and the disability assessment for dementia scale.

Assessment also was made of the effect of apolipoprotein E4 genotype on response to treatment.

At six months, patients who received galantamine had a significantly better outcome on the 11 item cognitive subscale than patients in the placebo group; mean treatment effect 2.9 points for lower dose and 3.1 for higher dose.

Galantamine was found to be more effective than placebo on the clinician's interview-based impression of change and added to impressions by the caregivers. At six months, patients in the higher dose galantamine group had significantly better scores on the disability assessment for dementia scale than patients in the placebo group.

At the same time clinicians found that apolipoprotein E genotype had no effect on the efficacy of galantamine.

"Our study shows that, compared with placebo, galantamine significantly improved cognition and global function in patients with mild to moderate Alzheimer's disease," the clinicians point out. "These therapeutic effects were associated with significant benefits on patients' activities of daily living."

Monthly rate of discontinuations due to adverse events with galantamine was comparable to the rate with placebo during the maintenance phase of the study. Clinicians added that "the rapid, rigid dose escalation procedure may have contributed to patients discontinuing galantamine treatment."

In a recent, five-month, placebo-controlled study of galantamine, in which the dose was escalated over eight weeks, the proportion of patients who discontinued galantamine 24 mg/day due to adverse events was low (10 percent) and comparable to that in the placebo group (seven percent).

"In clinical practice, patients' tolerance of galantamine might be improved by starting at a low dose and escalating the dose slowly," the clinicians concluded.
"Efficacy and safety of galantamine in patients with mild to moderate Alzheimer's disease: multicentre randomised controlled trial"

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