Objective: To evaluate the efficacy of galantamine in patients with Alzheimer’s disease with cerebrovascular disease (AD + CVD) or probable vascular dementia (VaD), based on baseline disease severity.
Methods: In a 6-month, randomized, double-blind, placebo-controlled trial, patients received either galantamine 24 mg/day (n = 359) or placebo (n = 178). Primary endpoints were the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) and the Clinician’s Interview-Based Impression of Change-Plus Caregiver Input (CIBIC-plus). Secondary measures included noncognitive endpoints: the Disability Assessment for Dementia scale (DAD; activities of daily living) and the Neuropsychiatric Inventory (NPI; behavior). A subgroup analysis was performed to determine the effects of galantamine in patients with mild (MMSE ³ 18) versus moderate (MMSE < 18) disease.
Results: Galantamine was effective in patients with mild or moderate dementia. Patients with mild disease showed greater mean improvement on the ADAS-cog (1.61 vs 0.68 points, respectively). Similarly, patients with mild dementia showed better results on the DAD. Results on the CIBIC-plus were similar in both galantamine-treated subgroups, regardless of baseline MMSE score. Conversely, patients with more severe disease demonstrated greater benefit on behavioral symptoms.
Conclusion: Galantamine demonstrated broad clinical efficacy in patients with AD + CVD or probable VaD, regardless of baseline disease severity. New treatments, such as galantamine, that have clinically relevant effects may have important economic benefits, potentially reducing caregiver burden and postponing institutionalization.
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