Primary outcome
dementia
The estimate corresponding to the primary estimand of the NPI-Q severity of the PwD at 90 days will be obtained from a likelihood-based longitudinal data analysis model, with responses consisting of all scores (baseline, 90 and 180 days post-randomisation) [In sensitivity analysis, variables known to be prognostic of NPI-Q severity (i.e. type of dementia, gender of PwD and CG’s relationship with PwD) will be included in the unadjusted longitudinal data analysis model. This model will be referred to as the adjusted model. The treatment effect estimated from the unadjusted and adjusted models will be the mean difference in NPI-Q severity from baseline to 90 days post-randomisation between the MI plus SC versus SC alone groups.