Effect of unawareness on rehabilitation outcome in a randomised controlled trial of multicomponent intervention for patients with mild Alzheimer's disease.
Unawareness of deficit has been shown to affect the outcome of targeted cognitive intervention programmes applied to patients with Alzheimer' disease (AD), but the effects on multimodal therapeutic approaches have not yet been explored. This research investigated the efficacy of the Multi-Intervention Programme (MIP) approach on improving cognitive, functional, affective, and behavioural symptoms in people with mild AD. In addition, we examined whether the presence of unawareness influences the MIP outcomes. Sixty-one mild stage AD patients were randomly assigned to either an experimental group which carried out an MIP individually (48 sessions, 16 weeks duration), combining diverse cognitive tasks, training in daily life and recreational activities, or a waiting list group which did not receive any treatment for the same time period. The efficacy of MIP (vs. waiting list) was tested using various standardised neuropsychological, functional, and behavioural outcome measures. Planned analyses were carried out to determine the effect of unawareness versus awareness on such outcomes. The results showed that patients overall benefited from the MIP in terms of both cognitive and non-cognitive symptoms. AD patients with awareness of deficits showed positive effects on all outcome measures in comparison with the waiting list group, while AD patients with unawareness showed improvements in non-cognitive symptoms only. In conclusion, the presence of unawareness reduces the cognitive and functional effects of MIP in patients with mild AD.