Risperidone and rivastigmine and agitated behaviour in severe Alzheimer's disease: a randomised double blind placebo controlled study

Holmes, Clive; Wilkinson, David; Dean, Christine; Clare, Corinne; El-Okl, Mohammed; Hensford, Christine; Moghul, Sheram

doi:10.1002/gps.1667

Cited by 23 publications

(13 citation statements)

References 3 publications

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“…We have previously shown that donepezil and rivastigmine have largely neutral effects on agitation [13,14,35]. …”

Section: Discussionmentioning

confidence: 99%

“…At the time of the development of the protocol, there was evidence to show that donepezil had a beneficial effect on agitation, so it was an appropriate comparator agent [13,29]. Donepezil was prescribed, according to standard clinical practice following licensed recommendations, at a dose of 5 mg a day increasing to 10 mg after 1 month.…”

Section: Methodsmentioning

confidence: 99%

“…Preliminary evidence indicates that a variety of other pharmacological agents, including memantine, citalopram and carbamazepine, may be candidate treatments – but more evidence is needed [4]. Cholinesterase inhibitors, traditionally used to improve cognitive function, appear to confer modest benefits in the overall treatment of neuropsychiatric symptoms [11,12], but results have been largely neutral for the treatment of agitation specifically [4,13,14]. Alternative non-pharmacological treatments such as bright-light therapy have marginal benefits [15,16].…”

Section: Introductionmentioning

confidence: 99%

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A Double-Blind Placebo-Controlled Randomized Trial of <i>Melissa officinalis</i> Oil and Donepezil for the Treatment of Agitation in Alzheimer’s Disease

Burns

Perry²,

Holmes

et al. 2011

Dement Geriatr Cogn Disord

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137

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Background/Aims: Behavioural and psychological symptoms (BPSD) are frequent in people with Alzheimer’s disease and cause considerable stress to patients and their carers. Antipsychotics have been widely used as a first-line treatment, resulting in an estimated 1,800 excess strokes and 1,600 excess deaths in the UK alone. Safe and effective alternatives are urgently needed. Based upon preliminary evidence from clinical trials, aromatherapy with melissa oil may be such an alternative, but initial studies have been modest in size, and adequate blinding has been problematic. Our objective was to assess the efficacy of melissa aromatherapy in the treatment of agitation in people with Alzheimer’s disease in an adequately powered and robustly blinded randomized controlled trial comparing it with donepezil, an anticholinesterase drug used with some benefit to treat BPSD. Methods and Findings: The study was a double-blind parallel-group placebo-controlled randomized trial across 3 specialist old age psychiatry centres in England. Participants had probable or possible Alzheimer’s disease, were resident in a care home, had clinically significant agitation (defined as a score of 39 or above on the Cohen Mansfield Agitation Inventory) and were free of antipsychotics and/or anticholinesterase for at least 2 weeks. Participants were allocated to 1 of 3 groups: placebo medication and active aromatherapy; active medication and placebo aromatherapy or placebo of both. Main Outcome: The primary outcome measure was reduction in agitation as assessed by the Pittsburgh Agitation Scale (PAS) at 4 weeks. This is an observational scale, and raters were required to wear nose clips to ensure that full blinding was maintained. The PAS, Neuropsychiatric Inventory (NPI; another measure of BPSD) and other outcome measures were completed at baseline, 4-week and 12-week follow-ups. 114 participants were randomized, of whom 94 completed the week 4 assessment and 81 completed the week 12 assessment. Aromatherapy and donepezil were well tolerated. There were no significant differences between aromatherapy, donepezil and placebo at week 4 and week 12, but importantly there were substantial improvements in all 3 groups with an 18% improvement in the PAS and a 37% improvement in the NPI over 12 weeks. Conclusion: When assessed using a rigorous design which ensures blinding of treatment arms, there is no evidence that melissa aromatherapy is superior to placebo or donepezil, in the treatment of agitation in people with Alzheimer’s disease. However, the sizeable improvement in the placebo group emphasizes the potential non-specific benefits of touch and interaction in the treatment of agitation in people with Alzheimer’s disease.

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“…We have previously shown that donepezil and rivastigmine have largely neutral effects on agitation [13,14,35]. …”

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

A Double-Blind Placebo-Controlled Randomized Trial of <i>Melissa officinalis</i> Oil and Donepezil for the Treatment of Agitation in Alzheimer’s Disease

Burns

Perry²,

Holmes

et al. 2011

Dement Geriatr Cogn Disord

Self Cite

137

View full text Add to dashboard Cite

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“…Many studies have compared the efficacy of Cholinesterase inhibitors with atypical antipsychotics for the decrease of agitation in patients with dementia. In research done by Holmes and his colleagues [40], risperidone, which is an atypical antipsychotic, was found to be more effective than the cholinesterase inhibitor, Rivastigmine. In a randomized doubleblind, placebo controlled trial, there were groups of people with AD treated with both quetiapine, an antipsychotic, and rivastigmine.…”

Section: Discussionmentioning

confidence: 99%

“…Evidence from case studies with depressive symptomatology and cognitive impairment, has led to the belief that depression in AD is a different disorder. However, in AD pharmacotherapy research, a combination of traditional Alzheimer's treatment and tricyclic antidepressants have a more efficacious impact [45,40].…”

Section: Discussionmentioning

confidence: 99%

The effect of Risperidone, Sertraline as monotherapy and in combination with Cholinesterase inhibitors on cognitive functioning due to Alzheimer’s Disease: A randomized clinical trial

Melissari-Tzanakaki¹,

Benioudakis²,

Botonaki³

et al. 2017

Alzheimers Dement Cogn Neurol

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Alzheimer's disease is a progressive neurodegenerative disorder which is characterized by the progressive decline in memory and other cognitive abilities. Behavioral and personality changes can also be present. Depression is also a neuropsychiatric aspect of Alzheimer's disease. Objective:The aim of this study is to compare the effect of risperidone as monotherapy in patients with behavioral problems, sertraline as monotherapy in patients with depression and with the combination of cholinesterase inhibitors on cognitive functioning due to Alzheimer's Disease. Methods and Participants:The study comprised 78 participants diagnosed with AD, all over fifty years of age. The participants were split into 4 groups: groups A and B had everyday behavioral problems, while groups C and D had co-morbid depression. Group A was treated with risperidone 1mg daily, group B with risperidone and cholinesterase inhibitors, Group C was treated with sertraline, and group D with sertraline and cholinesterase inhibitors. Baseline assessment of groups A and B was performed using the instrumental activities of daily living (IADL) Scale, Physical Self-Maintenance Scale (PSMS), Mini-Mental State Examination Scale (MMSE), while a follow-up assessment after three and six months was only with MMSE. Groups C and D were assessed with MMSE and the Montgomery-Asberg Depression Rating Scale for baseline assessment and follow-up after 12 months.Results: It was found that group A (treated with risperidone only) showed a statistically significant improvement in MMSE scores with respect to the baseline assessment after 6 months, An improvement not seen in group B (treated with risperidone and cholinesterase inhibitors). Groups C and D did not show any significant improvement in scores on either assessment scale. Conclusion:Risperidone used as monotherapy displayed a positive effect on cognitive function due to Alzheimer's.

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Efficacy and Comparative Effectiveness of Atypical Antipsychotic Medications for Off-Label Uses in Adults

Maher¹,

Maglione²,

Bagley³

et al. 2011

JAMA

521

400

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Benefits and harms vary among atypical antipsychotic medications for off-label use. For global behavioral symptom scores associated with dementia in elderly patients, small but statistically significant benefits were observed for aripiprazole, olanzapine, and risperidone. Quetiapine was associated with benefits in the treatment of generalized anxiety disorder, and risperidone was associated with benefits in the treatment of obsessive-compulsive disorder; however, adverse events were common.

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Risperidone and rivastigmine and agitated behaviour in severe Alzheimer's disease: a randomised double blind placebo controlled study

Cited by 23 publications

References 3 publications

A Double-Blind Placebo-Controlled Randomized Trial of <i>Melissa officinalis</i> Oil and Donepezil for the Treatment of Agitation in Alzheimer’s Disease

A Double-Blind Placebo-Controlled Randomized Trial of <i>Melissa officinalis</i> Oil and Donepezil for the Treatment of Agitation in Alzheimer’s Disease

The effect of Risperidone, Sertraline as monotherapy and in combination with Cholinesterase inhibitors on cognitive functioning due to Alzheimer’s Disease: A randomized clinical trial

Efficacy and Comparative Effectiveness of Atypical Antipsychotic Medications for Off-Label Uses in Adults

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