Efficacy and Safety of Rivastigmine in the Treatment of Behavioural and Psychological Symptoms in Chinese Dementia Patients: An Open-Label Study

Article excerpt

Abstract

Objectives: Behavioural and psychological symptoms of dementia are integral features of Alzheimer's disease. They have been recognised as important predictors for premature institutionalisation and constitute major caregiver burdens. This study examined the efficacy of rivastigmine in the treatment of behavioural and psychological symptoms of dementia in Chinese older adults suffering from mild-to- moderately severe Alzheimer's disease, under conditions reflecting everyday clinical care. Rivastigmine tolerability and its effects on cognition and functional status were also assessed.

Patients and Methods: This was a 20-week prospective, open-label, single-centre study. Twenty four psychogeriatric outpatients, who fulfilled DSM-IV diagnosis criteria for Dementia of the Alzheimer's Type and exhibited behavioural and psychological symptoms of dementia, were treated with flexible doses of rivastigmine. Clinical responses were evaluated using the Chinese version of the Neuropsychiatric Inventory (CNPI), the Cantonese version of the Mini-Mental State Examination (CMMSE), and Functional Assessment Staging (FAST).

Results: At week 20, the mean CNPI total score decreased by 19.5 (p < 0.001) with significant improvements regarding delusions, depression / dysphoria, apathy, disinhibition, irritability / lability, aberrant motor behaviour, and night-time behaviour disturbance. Clinically significant reductions in behavioural and psychological symptoms of dementia were observed in 20 (83%) of the patients. The percentage change in CNPI total score correlated with percentage change in CNPI caregiver distress score (Spearman's rho = 0.8, p < 0.001), but not with the rivastigmine dosage (Spearman's rho = 0.004, p = 0.99) or change in CMMSE score (Spearman's rho = -0.175, p = 0.41). No significant changes in CMMSE and FAST scores were demonstrated. The mean [+ or -] SD daily dose of rivastigmine was 9 [+ or -] 3 mg. Rivastigmine was well-tolerated in general, though a significant mean weight loss of 2 kg (p < 0.001) was noted.

Conclusion: This study suggested that rivastigmine was well-tolerated and effective in improving behavioural and psychological symptoms of dementia in Chinese patients with mild-to-moderately severe Alzheimer's disease. Its beneficial effect on behavioural and psychological symptoms of dementia was independent of dosage and cognitive response. More rigorous investigations are needed to confirm and clarify the potential therapeutic role of the drug in ameliorating behavioural and psychological symptoms of dementia.

Key words: Behavioral symptoms; Cholinesterase inhibitors; Alzheimer disease

Introduction

Alzheimer's disease (AD) is a neurodegenerative disorder characterised by progressive decline in memory and cognitive function, loss of ability to cope with activities of daily living, and disturbances in behaviour and emotions. (1,2) It is the commonest form of dementia, accounting for about two-thirds of all cases. (3) Until recently, researchers have focused primarily on interventions aiming to maintain cognitive and functional abilities of AD patients. Behavioural and psychological symptoms of dementia (BPSD) have received much less attention. Nonetheless, BPSD are common among these patients, (4,5) and are associated with aggravated carer burdens, (6) increased cost of care, (7,8) and premature institutionalisation. (9)

In the past decade, there has been a growth in the research of pharmacological therapies for BPSD. Among them, use of atypical antipsychotics provides evidence for efficacy, but their effects are only modest. (10) Besides, recent report of an increased likelihood of serious cerebrovascular adverse events in elderly demented patients treated with such agents has renewed interest in alternative therapies. (11) Evidence suggests that cholinergic deficit, while contributing to cognitive symptoms, is also implicated in the neuropsychiatric manifestations of AD. …