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P2–418: Specific benefits of memantine on behavioural symptoms in patients with moderate to severe Alzheimer's disease
Author(s) -
Gauthier Serge,
Cooper James,
Loft Henrik
Publication year - 2006
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2006.05.1259
Subject(s) - memantine , placebo , medicine , irritability , psychology , disease , dementia , pathology , alternative medicine , menopause
Background: Behavioural disturbances are common in Alzheimer’s Disease (AD), and are distressing for patients and caregivers. Beneficial effects of memantine on behavioural symptoms in mild to severe AD have previously been reported. Objective(s): This pooled analysis evaluated the specific benefits of memantine (20mg/day) on behavioural disturbances in all patients with moderate to severe AD (MMSE 20), corresponding to the new indication for memantine in Europe. Methods: Data from six 24-28 week, multicentre, randomised, placebo-controlled, parallel-group, double-blind studies were included. Three studies were in mild to moderate AD, and three were in moderate to severe AD, including two studies in patients already receiving stable doses of an acetylcholine esterase inhibitor. Behavioural symptoms were evaluated using the Neuropsychiatric Inventory (NPI), a 12-item assessment scale. Patients were rated on the NPI at Week 12 (W12) and Week 24/28 (W24). NPI total scores were analysed using ANCOVA; single items were analysed using non-parametric methods. Both OC and LOCF approaches were used. Results: The analyses included 959 patients on memantine and 867 on placebo. Analysis of total NPI scores showed a statistically significant benefit of memantine compared to placebo at W12 and W24 (p 0.05). Memantine showed advantages over placebo for most NPI single items at W12 and W24 with statistically significant benefits for Delusions (p 0.01; W12 24), Hallucinations (p 0.05; W12), Agitation/Aggression (p 0.001; W12 24), and Irritability/Lability (p 0.01; W24). Individual NPI single items were analysed in the subset of patients who were symptomatic for the item at baseline. Statistically significantly more memantine-treated patients than placebo-treated patients showed improvement on: Delusions (W24), Hallucinations (W12), Agitation/Aggression (W12 24), Elation/Euphoria (W12) and Disinhibition (W12 24). Single items were also analysed in the asymptomatic subset of patients. Here, statistically significantly less memantine-treated patients than placebo-treated patients showed deterioration on: Delusions (W12), Agitation/Aggression (W12 24), Disinhibition (W12), and Irritability/Lability (W24). LOCF results are presented here, but in all analyses the OC results were similar to those using LOCF. Conclusions: These results show that memantine improves the behavioural symptoms of patients with moderate to severe AD and that significant effects are observed by Week 12. Specific benefits were observed on symptoms often associated with caregiver burden.