OBJECTIVE: The purpose of this study was to examine the behavioural and cognitive effects of selegiline in a group of moderately behaviourally disturbed AD patients. DESIGN: This was a 14-week randomized double-blind placebo-controlled study of selegiline (10 mg) and placebo. SETTING:An outpatient clinic in an urban-based tertiary referral centre in the USA. PATIENTS: Twenty-five outpatients meeting NINCDS criteria for probable Alzheimer's disease with associated behavioural disturbance. MEASURES: The Brief Psychiatric Rating Scale (BPRS), the Dementia Mood Assessment Scale (DMAS) and the Alzheimer Disease Assessment Scale (Cognitive) (ADAS-COG). RESULTS: In the primary analysis, improvement on the BPRS and DMAS scores with selegeline treatment did not. reach statistical significance. A secondary analysis using a parallel design showed a significant benefit of drug treatment on BPRS scores with a trend towards improvement on the DMAS. Among the 10 subjects who could be tested, there was a significant improvement in cognitive function on the ADAS-COG with selegiline compared to placebo. CONCLUSIONS: Short-term selegiline treatment produced an improvement in behaviour and had a significant effect on cognition in a subset of testable patients.
RCT Entities:
OBJECTIVE: The purpose of this study was to examine the behavioural and cognitive effects of selegiline in a group of moderately behaviourally disturbed ADpatients. DESIGN: This was a 14-week randomized double-blind placebo-controlled study of selegiline (10 mg) and placebo. SETTING: An outpatient clinic in an urban-based tertiary referral centre in the USA. PATIENTS: Twenty-five outpatients meeting NINCDS criteria for probable Alzheimer's disease with associated behavioural disturbance. MEASURES: The Brief Psychiatric Rating Scale (BPRS), the Dementia Mood Assessment Scale (DMAS) and the Alzheimer Disease Assessment Scale (Cognitive) (ADAS-COG). RESULTS: In the primary analysis, improvement on the BPRS and DMAS scores with selegeline treatment did not. reach statistical significance. A secondary analysis using a parallel design showed a significant benefit of drug treatment on BPRS scores with a trend towards improvement on the DMAS. Among the 10 subjects who could be tested, there was a significant improvement in cognitive function on the ADAS-COG with selegiline compared to placebo. CONCLUSIONS: Short-term selegiline treatment produced an improvement in behaviour and had a significant effect on cognition in a subset of testable patients.