HONOLULU, HA -- March 6, 2003 -- The new cholinergic drug galantamine, used in the treatment of mild to moderate Alzheimer's Disease (AD), may deliver benefits in both cognitive function and noncognitive areas such as behaviour and physical functioning, according to research presented here March 4^th at the Annual Meeting of the American Association for Geriatric Psychiatry.

The drug, an acetylcholinesterase inhibitor, may improve overall functioning in AD patients, who tend to experience a decline in both cognitive and non-cognitive areas as their disease progresses.

To determine whether continued treatment also produced benefits in non-cognitive areas, Constantine Lyketsos, MD, of Johns Hopkins University in Baltimore, Maryland, and fellow researchers conducted the study an extension of two previous double-blind, placebo-controlled trials that looked at galantamine's efficacy in reducing cognitive impairment in 699 patients with mild to moderate AD.

Patients who had Mini-Mental State Examination (MMSE) scores of 11 to 24 and a score of at least 12 on the Alzheimer's Disease Assessment Scale (ADAS) cognitive subscale were included in the open-label extension study. Subjects enrolled in the original 6.5-month double-blind trial received a galantamine daily dosage of 8 mg to 24 mg for five months. Patients in the extension phase received 24 mg/day.

To measure non-cognitive function, researchers in the extension study used the AD Cooperative Study of Activities of Daily Living (ADCS/ADL) scores; behaviour was measured using the Neuropsychiatric Inventory (NPI) scale. Baseline mean ADCS/ADL and NPI scores for the galantamine-only group (288) were 54.4 and 10.8, respectively. Mean age was 76.5 years and mean MMSE score was 18.2.

In all treatment groups, mean total NPI scores showed small increases from baseline to later points in the study—an indication that all patients experienced worsening of their disease. However, the group treated with galantamine continuously for the 18.5 months of the extension period experienced the least decline (1.75) compared with the patients who received placebo during any part of the study. The treatment group also had a smaller decline in ADCS/ADL scores (-10.8).

The study, the first to look at long-term behavioural and functional benefits of galantamine in AD, may have long-term implications for treatment, Dr. Lyketsos said. Preservation of function could translate into a longer period of independence for patients with AD while reducing healthcare resource utilization, he explained.

Despite the limitations of the open-label design, he said, the study suggests that early treatment may be beneficial on non-cognitive domains, and there is potential for prolonged non-cognitive benefits with galantamine.


[Study title: Galantamine Demonstrates Noncognitive Benefits In Patients With Mild-To-Moderate Alzheimer's Disease Up To 18.5 Months]

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