Objective: To report examples of improvement/deterioration of patients treated with galantamine, and to evaluate the pharmacoeconomic value of galantamine in the assisted-living setting. Secondary objectives included the impact of galantamine on improvements in functionality; its effect on behavioral changes as actually reported by facility caregivers; its effect on the use of neuroleptics and antipsychotics; and evaluation of facility caregiver impression of treatment and their level of satisfaction.
Design: Patients aged 65 years or older with moderate-to-severe Alzheimer’s disease (AD) (according to ICD9, DSM-IV, and NINCDS-ADRDA criteria) were recruited from a large outpatient clinic and received open-label galantamine (starting dose 8 mg/day in 2 divided doses, with increases of 8 mg/month until the maximum dose of 24 mg/day was reached) for a total of 6 months. Patients with an unstable medical condition, who had received an acetylcholinesterase inhibitor <30 days before the start of the study, or had a known hypersensitivity to galantamine were excluded. Materials and methods: Effects of treatment on cognition were analyzed using the change from baseline in scores on the Mini-Mental State Examination (MMSE) and Severe Impairment Battery (SIB). Basic activities of daily living (ADL) and instrumental activities of daily living (IADL) were monitored to evaluate changes in function. Changes in behavior were measured by the Neuropsychiatric Inventory (NPI). The Alzheimer's Medication Caregiver & Clinical Impression Evaluation (AMCIE) was used to provide “real-world” caregiver impression of the patient's treatment response. Nursing home admission rates and prevalence rates of neuroleptic and anxiolytic use also were documented. Reported weight loss, fall rate, and adverse event monitoring were used to analyze safety.
Results: 25 patients were enrolled (mean age: 84.2 [SD: 6.3]; M/F: 7/18; race: Caucasian [100%]). After 6 months of galantamine treatment, cognition and function were at baseline levels (p > 0.1 vs baseline for MMSE, SIB, ADL, and IADL). More importantly, behavior improved significantly (change from baseline [NPI] at endpoint: –9.43 [SE: 4.13], p < 0.05 vs baseline). 33% (7/21) of patients showed an increase of ³ 0 points (indicating improvement) on the MMSE, whereas 87% (20/23) patients showed a decrease in NPI score ³ 0 (indicating improvement) after 6 months of galantamine treatment. 76% (16/21) of patients had a decrease or no change in, or completely discontinued, their antipsychotic medication. At endpoint, these patients showed greater improvement on NPI compared to patients who had an increase in the number of antipsychotic medications (–11.6 [SE: 4.43] vs –6.2 [13.46]). The most frequently reported adverse event was agitation (characteristic of an elderly dementia population).
Conclusions: Galantamine treatment delayed cognitive and functional decline and improved behavior in patients with moderate-to-severe AD. Behavioral disturbances manifest late in the course of AD and are often the primary reasons for nursing home placement. Delaying the progression of AD can result in economic benefits.
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