Objective: Rigorous safety and efficacy trials required for registration of new therapies often involve patients who differ from those who attend clinics on a daily basis. This study aims to document clinical experience with galantamine in a naturalistic setting.
Design: Prospective, multi-centre observational study.
Materials and Methods: Data from the first 3 months of a 6-month study are reported for 122 patients (55 male, 67 female, aged 78.4 ± 10 years [mean ± SD]), currently living at home with mild-moderately severe dementia of the Alzheimer’s type. Changes from baseline in cognition, behaviour and function were assessed at 3 months using the Mini-Mental State Examination (MMSE), an 11-point behavioural assessment scale and abridged Instrumental Activities of Daily Living (IADL). The Clinician Interview Based Impression of Change (CIBIC-plus) was assessed at 3 months.
Results: Dementia was first diagnosed by a specialist a mean of 8.4 ± 18 months prior to the baseline visit. At 3 months, no change in use of Meals On Wheels, external help, or time left unsupervised occurred and the behavioural assessment scale did not change significantly, indicating no deterioration. The mean MMSE score improved from 20.8 ± 4.1 to 22.3 ± 4.4 points, (p < 0.01) and 68.5% of patients improved while 17.1% remained stable. No deterioration in IADL was observed over 3 months. In 88.4% of patients, no deterioration in CIBIC+ score occurred and of these, 59.8% improved.
Conclusion: In a naturalistic setting, galantamine maintains cognitive performance, behaviour and function in the majority of patients over three months and improves many of these domains in some patients.
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