Poster Session 2, Monday 25 August

Abstract

cancelled P2002The SERAD study: galantamine improves cognitive function in nursing home patients with severe Alzheimer's disease Background and aims: Data on cholinesterase inhibitor therapy of patients with severe Alzheimer's disease (AD) are limited. The SERAD study assessed the efficacy of galantamine on cognitive function and activities of daily living (ADL) in nursing home patients with severe AD. Methods: During a 6-month, double-blind, placebo-controlled phase of a multicentre study, galantamine was titrated from 8 to 24 mg/day, with subsequent reduction to 16 mg/day if necessary. The co-primary efficacy variables were cognitive function (Severe Impairment Battery [SIB]), and ADL (Minimum Data Set -Activities of Daily Living [MDS-ADL]), with efficacy analyses based on an intent-to-treat population with observed-case analysis at week 26. Results: 407 patients were enrolled, and 168/207 (81%) receiving galantamine and 160/200 (80%) receiving placebo completed 6 months of treatment. Mean SIB score improved by 1.9 in the galantamine group, vs. deterioration of 3.0 with placebo (p=0.006). Mean MDS-ADL scores worsened by 1.2 and 1.6 points in the galantamine and placebo groups, respectively (p=0.384). The most common adverse events were urinary tract infection (galantamine, 16%; placebo, 22%), vomiting (16% vs. 15%), diarrhoea (14% vs. 18%), nausea (12% vs. 6%) and fall (12% vs. 11%). Serious adverse events occurred in 18% and 21% of patients in the galantamine and placebo groups, respectively. 8 deaths (4%) occurred in the galantamine group and 21 (11%) in the placebo group (p=0.0012). Conclusion: In patients with severe AD, galantamine is well tolerated and associated with significant improvement in cognitive function, but not ADL, compared with placebo after 26 weeks of treatment. Aims:To investigate associations between dementia severity (MMSE), levels of CSF total-tau and p-tau181 and regional cerebral glucose metabolism measured with 18F-FDG-PET in brain regions typically affected by neurofibrillary tangle pathology in Alzheimer's disease (AD) patients. Methods: In 38 patients (mean age 66.5±8.0 years) with probable AD Mini-Mental State Examination (MMSE) scores were evaluated and CSF levels of t-tau and p-tau181 were measured. All patients received an 18FDG-PET scan under resting conditions. Image analysis (smoothing, normalization and automated VOI analysis to obtain regional values of glucose metabolism) were performed using the software "VINCI" (Volume Imaging in Neurological Research, Co-Registration and ROIs included). Results: No correlations were found between levels of CSF biomarkers and MMSE scores (t-tau: rP=-0.105, p=0.529; p-tau181: rP= -0.007, p=0.967). T-tau correlated only weakly with impairment of glucose metabolism in parietal cortex, amygdala and precentral gyrus and P-tau181 did not correlate at all. Several correlations were detectable between MMSE and reduced glucose metabolism in precuneus, posterior cingulate, parietal and occipital cortex as well as in medial and inferior temporal ...