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Objectives To determine the respective efficacy of quetiapine and rivastigmine for agitation in people with dementia in institutional care and to evaluate these treatments with respect to change in cognitive performance. Design Randomised double blind (clinician, patient, outcomes assessor) placebo controlled trial. Setting Care facilities in the north east of England. Participants 93 patients with Alzheimer's disease, dementia, and clinically significant agitation. Intervention Atypical antipsychotic (quetiapine), cholinesterase inhibitor (rivastigmine), or placebo (double dummy). Main outcome measures Agitation (Cohen-Mansfield agitation inventory) and cognition (severe impairment battery) at baseline and at six weeks and 26 weeks. The primary outcome was agitation inventory at six weeks. Results 31 patients were randomised to each group, and 80 (86%) started treatment (25 rivastigmine, 26 quetiapine, 29 placebo), of whom 71 (89%) tolerated the maximum protocol dose (22 rivastigmine, 23 quetiapine, 26 placebo). Compared with placebo, neither group showed significant differences in improvement on the agitation inventory either at six weeks or 26 weeks. Fifty six patients scored > 10 on the severe impairment battery at baseline, 46 (82%) of whom were included in the analysis at six week follow up (14 rivastigmine, 14 quetiapine, 18 placebo). For quetiapine the change in severe impairment battery score from baseline was estimated as an average of − 14.6 points (95% confidence interval − 25.3 to − 4.0) lower (that is, worse) than in the placebo group at six weeks (P = 0.009) and − 15.4 points ( − 27.0 to − 3.8) lower at 26 weeks (P = 0.01). The corresponding changes with rivastigmine were − 3.5 points ( − 13.1 to 6.2) lower at six weeks (P = 0.5) and − 7.5 points ( − 21.0 to 6.0) lower at 26 weeks (P = 0.3). Conclusions Neither quetiapine nor rivastigmine are effective in the treatment of agitation in people with dementia in institutional care. Compared with placebo, quetiapine is associated with significantly greater cognitive decline.

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Clinical dementia associated with measurable cognitive and functional decline is frequent in people with DS after middle age, and can be readily diagnosed among less severely intellectually disabled persons using measures of cognitive function such as the PCFT and behavioural scales such as the ABS. In the more profoundly disabled people, the diagnosis of dementia is facilitated by the use of behavioural and neurological criteria. In this study, the largest prospective DS series including neuropathology on deceased patients, the density of neurofibrillary tangles related more closely to the dementia of DS than senile plaques. In people with DS surviving to middle and old age, the development of dementia of Alzheimer type is frequent but not inevitable, and some people with DS reach old age without clinical features of dementia.

Language disorders are associated with both behavioural and psychological symptoms of dementia even when severity of dementia is controlled for. Patients' needs in communication skills should be addressed earlier to help them maintain social interactions and reduce the impact on behavioural problems and patients' quality of life.

APP is an important locus predicting the age at onset of dementia in people with Down syndrome.

The PCFT provides a reliable quantitative measure of cognitive function in subjects with DS, and could be a useful adjunct to the diagnosis of dementia in prospective studies. However, the almost uniformly low scores obtained by those with high levels of ID suggests that its power to detect cognitive decline will be limited to those who are less disabled, while the ABS may be more useful than the PCFT in detecting deterioration in people with profound ID.

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