Source: DGNews  |  Posted 8 years ago

By Bonnie Darves

HONOLULU, HA -- March 5, 2003 -- Galantamine appears to provide long term benefits to patients with vascular dementia or Alzheimer's disease and concomitant cardiovascular disease (CVD).

The findings are important because impairment in cholinergic function is thought to be a contributing factor in cognitive decline in both types of dementia, according to researchers led by Alexander Kurz, of the Technischem Universitaet Munchen, in Munich, Germany.

He presented the two-year, open-label extension multicentre study, conducted in Germany, Finland and the United Kingdom, here March 3rd at the Annual Meeting of the American Association for Geriatric Psychiatry.

They enrolled 326 patients with either vascular dementia or Alzheimer's disease and concomitant CVD who had been taking the new cholinergic drug galantamine for the 6 months prior to study entry. All patients were given 24 mg/day of galantamine for 12 months.

Inclusion criteria were a Mini-Mental State Examination score of 10 to 25, an Alzheimer's Disease Assessment Scale cognitive subscale score of 12 or greater, disease onset between ages 40 and 90, and availability of a responsible caregiver.

Of the patients, 105 received placebo in the 6-month double-blind phase and galantamine for the remaining 18 months, and 221 received galantamine for 24 months. Mean age was 76 years for both groups.

Patients who received galantamine for 24 months had an overall deterioration in cognitive scores on the Alzheimer's Disease Assessment Scale of 2.7 over 24 months, compared with a 3.1 decline in the group that received galantamine for 18 months.

In patients with vascular dementia, cognition remained above baseline levels for 21 months and the difference was not statistically significant from baseline levels at 24 months. In those with both Alzheimer's disease and CVD, cognition was maintained above baseline levels for 12 months.

Most frequent adverse events were those generally expected in elderly patients with dementia: depression, agitation and insomnia. The nausea and vomiting seen in the original study decreased during the extension phase. In all, 8.1% of patients who received galantamine for 24 months discontinued treatment because of adverse events, compared with 8.6% of those who received it for 18 months.

The results of the trial are promising in that galantamine appears to be both well tolerated and efficacious over the long term -- which increases its potential use in a broad range of patients with dementia, the researchers concluded.

[Study title: Long-term Safety and Efficacy of Galantamine in the Treatment of Probable Vascular Dementia or Alzheimer's Disease with Cerebrovascular Disease: An Interim Analysis]