PW01-263 - Galantamine Compared To Risperidone In Neuropsychiatric And Behavioural Symptoms In Alzheimer Patients: A One-Center Clinical Trial In 100 Patients

Abstract

Neuropsychiatric symptoms and behavioral disturbances in dementia (BPSD) are key symptoms of AD, adds to cognitive decline and causes an increased caregivers burden. Antipsychotics provide a limited treatment option and acetylcholineesterase inhibitors (AchEI) also show beneficial effects in treatment of BPSD.

Objective

To compare treatment effects between AchEI (galantamine, GAL) and antipsychotics (risperidone, RIS) in patients with BPSD.

Methods

Open randomized trial in 100 patients (mean 78.7years, 67% females) using the NeuroPsychiatric Inventory score (NPI)>10 on patients (73% mild to moderate AD and 27% other dementias, treated with GAL (n=50) or RIS (n=50) for 12 weeks. Neuropsychiatric symptoms (NPI, CMAI, FAST), caregivers stress (PGWB), cognition (MMSE) and severity (CIBIC) were assessed at baseline and 12 weeks.

Results

91 patients completed the trial. Safety and tolerability were good. 58% were APOEɛ4 carriers. At baseline MMSE was 20.1±4.6, and NPI 51.0±25.8. After 12 weeks NPI total scores had improved significantly (GAL: 16.6±16.1, RIS: 16.2±16.2).

In both groups there were statistically significant improvements after 12 weeks. In several of the NPI-domains galantamine and risperidone were equally effective. RIS showed a significant treatment advantage in the NPI-domains irritation (p=0.02), agitation (p=0.02) and a trend in aberrant motor behaviour (p=0.08). GAL showed a ppositive trend in apathy/indifference (p=0.09), night time behaviour (p=0.07) and appetite (p=0.06). GAL improved MMSE scores with 2.8 p (p< 0.001) and RIS with 1 p (p< 0.07).

Conclusion

This indicates that GAL could be beneficial in the treatment of neuropsychiatric and behavioural symptoms underlying AD unless aggressive symptoms are prominent.