| Methods |
Allocation: Block randomisation
Blindness: Triple ‐ clinician, patient and assessors.
Duration: 23 weeks. 20 weeks treatment followed by 3 weeks 'rest'. |
| Participants |
Diagnosis: Lewy‐body dementia. N = 120.
Age: Mean 73.9, SD 6.5, Range 57‐87.
Sex: F 68, M 52.
Setting: Dementia assessment clinics in Spain, UK and Italy.
Inclusion: Clinical diagnosis of DLB. MMSE > 9. With regular carer.
Exclusion: Severe extrapyramidal symptoms, asthma, taking neuroleptics, anticholinergics, selegiline or similar drugs. |
| Interventions |
1. Rivastigmine. Started at 1.5 mg twice daily, titrated to 6mg twice daily (or maximum tolerated) over 8 weeks maximum. |
| Outcomes |
Neuropsychiatric Inventory, 10 and 4 item versions (NPI‐10 & NPI‐4).
Speed of response to selected tests.
Clinical Global Change plus (CGC‐plus).
Mini Mental State Examination (MMSE).
Unified Parkinsons Disease Rating Scale (UPDRS). |
| Notes |
Data on speed of response was not used in this Cochrane review, as we viewed it as a proxy measure rather than a direct measure of a clinically important feature of DLB.
We were unable to include the UPDRS, as data was not presented in the published paper. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
