Double blind randomised placebo controlled trial of low dose melatonin for sleep disorders in dementia. Aromatherapy and behaviour disturbances in dementia: a randomized controlled trial. Efficacy of an evidence-based cognitive stimulation therapy programme for people with dementia: randomised controlled trial. Behavioural management of aggression in dementia: a randomized controlled trial. Lavender oil as a treatment for agitated behaviour in severe dementia: a placebo controlled study. Memantine in the treatment of mild to moderate dementia syndrome. A double-blind placebo-controlled study. Efficacy of galantamine in probable vascular dementia and Alzheimer's disease combined with cerebrovascular disease: a randomised trial. Efficacy of antipsychotic medications in behaviorally disturbed dementia patients. The effect of therapeutic touch on behavioral symptoms of persons with dementia. Oral physostigmine as treatment for primary degenerative dementia: a double-blind placebo-controlled inpatient trial. Fluvoxamine in the treatment of demented elderly patients: a double-blind, placebo-controlled study.
Disturbance of sleep is common in individuals with dementia where there may be reversal of the sleep-wake cycle. People with dementia of the Alzheimer's type have melatonin secretion rhythm disorders. There is some evidence that treatment with exogenous melatonin is an effective treatment for sleep disturbance associated with dementia. A randomised double blind placebo controlled cross over trial was undertaken to test the hypothesis that slow release exogenous melatonin 6 mg improves sleep for people with dementia.
                Forty-four participants with DSM-IV diagnoses of dementia with sleep disturbance were selected for a seven week randomised double blind cross over trial of slow release melatonin 6 mg versus placebo. Sleep parameters were objectively measured using wrist actigraphy.
                Twenty-five out of 44 completed the trial. Sleep was significantly disturbed in the sample population. Melatonin had no effect on median total time asleep (n=25, z=1.35, p=0.18), number of awakenings (n=25, z=0.32, p=0.75) or sleep efficiency (n=25, z=0.17, p=0.24). Nor were there any carry over effects from melatonin.
                Contrary to previous findings, we found no evidence that two weeks of exogenous melatonin is effective in improving sleep in people with dementia, although possible benefits of melatonin following longer periods of administration cannot be discounted.
                Copyright 2002 John Wiley & Sons, Ltd. A random controlled trial of the relaxing effects of an aromatherapy massage on disordered behaviour in dementia was conducted. Twenty-one patients were randomly allocated into one of three conditions, aromatherapy and massage (AM), conversation and aromatherapy (CA) and massage only (M). AM showed the greatest reduction in the frequency of excessive motor behaviour of all three conditions. This reached statistical significance between the hours of three and four pm (p < 0.05). Post hoc analysis suggested that at this time of day the AM consistently reduced motor behaviour when compared with CA (p = 0.05). This provides preliminary evidence of a measurable sedative effect of aromatherapy massage on dementia within a robust scientific paradigm. Further research is recommended with an expanded sample size.
                Copyright 2001 John Wiley & Sons, Ltd. A recent Cochrane review of reality orientation therapy identified the need for large, well-designed, multi-centre trials.
                To test the hypothesis that cognitive stimulation therapy (CST) for older people with dementia would benefit cognition and quality of life.
                A single-blind, multi-centre, randomised controlled trial recruited 201 older people with dementia. The main outcome measures were change in cognitive function and quality of life. An intention-to-treat analysis used analysis of covariance to control for potential variability in baseline measures.
                One hundred and fifteen people were randomised within centres to the intervention group and 86 to the control group. At follow-up the intervention group had significantly improved relative to the control group on the Mini-Mental State Examination (P=0.044), the Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog) (P=0.014) and Quality of Life - Alzheimer's Disease scales (P=0.028). Using criteria of 4 points or more improvement on the ADAS-Cog the number needed to treat was 6 for the intervention group.
                The results compare favourably with trials of drugs for dementia. CST groups may have worthwhile benefits for many people with dementia. To evaluate the efficacy of a brief behaviour management training programme for family carers of patients with dementia and aggressive behaviour.
                A randomized controlled trial of a four-session, community-based behaviour management programme. The primary outcome measure was the Rating Scale for Aggressive Behaviour in the Elderly.
                62 patients with dementia, and their co-resident carers.
                There were no significant differences in aggression scores between behaviour management and control groups at follow-up. After adjusting for baseline differences in Rating Scale for Aggressive Behaviour in the Elderly scores, there was a trend towards a reduction in aggressive behaviour in the patients in the behaviour management group compared with those in the control group (F = 3.37, P = 0.071).
                This study adds to the small evidence base for the effectiveness of behavioural management strategies in dementia. To determine whether aromatherapy with lavender oil is effective in the treatment of agitated behaviour in patients with severe dementia.
                A placebo controlled trial with blinded observer rater.
                A long-stay psychogeriatric ward.
                Fifteen patients meeting ICD-10 diagnostic criteria for severe dementia and suffering from agitated behaviour defined as a minimum score of three points on the Pittsburgh Agitation Scale (PAS).
                A 2% lavender oil aromatherapy stream was administered on the ward for a two hour period alternated with placebo (water) every other day for a total of ten treatment sessions.
                For each subject 10 total PAS scores were obtained. Five during treatment and five during placebo periods.
                Nine patients (60%) showed an improvement, five (33%) showed no change and one patient (7%) showed a worsening of agitated behaviour during aromatherapy compared with placebo. A comparison of the group median PAS scores during aromatherapy showed a significant improvement in agitated behaviour during aromatherapy compared with placebo (median PAS scores 3 c.f. 4; Wilcoxon Signed-Ranks test p = 0.016 (one-tailed)).
                Lavender oil administered in an aroma stream shows modest efficacy in the treatment of agitated behaviour in patients with severe dementia.
                Copyright 2002 John Wiley & Sons, Ltd. The efficacy and the tolerability of memantine (1-amino-3,5-dimethyladamantane hydrochloride, Akatinol Memantine, CAS 41100-52-1) were investigated in patients with mild to moderate dementia syndrome in a randomized two-centre placebo-controlled clinical study. The test substance was administered at a dose of 10 mg/d from day 1 to day 3 and then at a dose of 2 x 10 mg/d from day 4 to the end of treatment after 42 days. Altogether, 88 patients were recruited to the study; their average age was 71.5 years. The efficacy of memantine was judged on the basis of the baseline/6 week differences in the total sum scores of the Clinical Assessment Geriatric Scale (SCAG), the Gottfries-Bräne-Steen Scale (GBS), the SCAG and GBS subscales and the global assessment of the change in the patient's condition. The effects of memantine on performance were studied with the aid of psychomotor tests and a behaviour investigation relating to activities of daily living (ADL). The tolerability of memantine was assessed on the basis of the doctor's global assessment and of entries on structured documentation forms (DOTES/TWIS). Further safety parameters--in the form of clinicochemical tests and measurements of blood pressure and heart rate--were also monitored during the study. On both the psychopathological measurement level (SCAG, global assessment of the change in the patient's condition) and the behavioural level (GBS), confirmatory statistical analysis brought to light significant differences between memantine and placebo (p less than or equal to 0.05), these differences showing a superiority of memantine. The tolerability of memantine was good in the main. The observed adverse reactions were not serious and, except in 3 patients, were rated as causing little or no impairment. The present clinical study demonstrates the efficacy of memantine in patients suffering from mostly moderate dementia syndrome. Clinical and statistically relevant improvements in the dementia-induced disturbances were found on the both the psychopathological level (SCAG, CGI) and the behavioural level (GBS). On the performance level also, the ADL behaviour investigation detected a highly significant improvement in the quality of performance of instrumented activities of daily living under memantine. Also the time taken to carry out these tasks was significantly reduced in comparison with placebo. Vascular dementia is the second commonest form of dementia, and vascular factors contribute to the development of dementia in many patients with Alzheimer's disease. Galantamine amplifies the acetylcholine response by inhibiting acetylcholinesterase and modulating nicotinic receptors. It has shown broad, sustained benefits in patients with Alzheimer's disease. We investigated the effects of galantamine in patients with a diagnosis of probable vascular dementia or Alzheimer's disease combined with cerebrovascular disease.
                Eligible patients were randomly assigned galantamine 24 mg/day (n=396) or placebo (n=196) in a multicentre, double-blind, 6-month trial. Primary endpoints were cognition (Alzheimer's disease assessment scale, cognitive subscale [ADAS-cog]) and global functioning (clinician's interview-based impression of change plus caregiver input [CIBIC-plus]). Secondary endpoints included assessments of activities of daily living and behavioural symptoms. Patients were monitored for adverse events. Analyses were on the basis of observed case or last observation carried forward.
                Galantamine showed greater efficacy than placebo on ADAS-cog (galantamine change -1.7 [SE 0.4] vs placebo 1.0 [0.5]; treatment effect 2.7 points; p<0.0001) and CIBIC-plus (213 [74%] vs 95 [59%] patients remained stable or improved, p=0.0001). Activities of daily living and behavioural symptoms were also significantly improved compared with placebo (p=0.002 and p=0.016, respectively). Galantamine was well tolerated.
                Galantamine showed a therapeutic effect on all key areas of cognitive and non-cognitive abilities in this group of dementia patients. This study compared the therapeutic efficacy of thioridazine, loxapine, and a placebo in the treatment of behavioral disturbances in nursing home patients with dementia. Antipsychotic medications were effective for the specific behavioral problems of anxiety, excitement, emotional lability, and uncooperativeness. Subjects with the most severe symptoms at baseline assessment derived the greatest benefit from treatment. Sedation, extrapyramidal symptoms, and decreased blood pressure were common side effects among patients treated with the antipsychotic drugs. The authors conclude that antipsychotic medication has a definite but limited therapeutic role in the treatment of behavioral disturbances in nursing home patients with dementia. Approximately 80% of nursing home residents who suffer from Alzheimer's disease and related dementia develop behavioral symptoms of dementia. Given the deleterious side effects of pharmacologic therapy in this population there is an urgent need for clinical trials of nonpharmacologic interventions.
                To examine the effect of therapeutic touch on the frequency and intensity of behavioral symptoms of dementia.
                A randomized, double-blind, three-group experimental study: experimental (therapeutic touch), placebo (placebo therapeutic touch), and control (usual care). Fifty-seven residents, aged 67 to 93 years, exhibiting behavioral symptoms of dementia, were randomized to one of the three groups within each of three Special Care Units within three Long-Term Care facilities in a western Canadian province. Behavioral observation was completed every 20 minutes from 8:00AM to 6:00PM for three days pre-intervention and for three days post-intervention by trained observers who were blind to group assignment. The intervention consisted of therapeutic touch given twice daily for 5-7 minutes for three days between 10:00AM and 11:30PM and between 3:00PM and 4:30PM (N = 57). The main outcome variable was overall behavioral symptoms of dementia, consisting of six categories of behaviors: manual manipulation (restlessness), escape restraints, searching and wandering, tapping and banging, pacing and walking, and vocalization.
                Analysis of variance (ANOVA) (F = 3.331, P = .033) and the Kruskal-Wallis test (chi2 = 6.661, P = .036) indicated a significant difference in overall behavioral symptoms of dementia, manual manipulation and vocalization when the experimental group was compared to the placebo and control groups. The experimental (significant) was more effective in decreasing behavioral symptoms of dementia than usual care, while the placebo group indicated a decreasing trend in behavioral symptoms of dementia compared to usual care.
                Therapeutic touch offers a nonpharmacological, clinically relevant modality that could be used to decrease behavioral symptoms of dementia, specifically manual manipulation (restlessness) and vocalization, two prevalent behaviors. Twenty-three patients with primary degenerative dementia (Alzheimer's disease) were administered an optimal dose of oral physostigmine and placebo, each for a 1-week period, under double-blind conditions on a research unit of a general hospital. Each patient served as his or her own control. The optimal dose of physostigmine for each patient was determined previously by a dose-finding phase. There were no significant group differences on a number of neuropsychological tests. Along with other studies in the literature, this study casts serious doubt on the efficacy of short-term administration of oral physostigmine when used alone in an attempt to ameliorate cognitive dysfunction in Alzheimer's disease patients. The possibilities that physostigmine may slow the course of the disease or may acutely improve symptoms when combined with other agents are discussed. The efficacy of fluvoxamine on cognitive functioning and behavioral changes was evaluated in a double-blind, placebo-controlled study of 46 elderly demented patients. The patients had a DSM-III diagnosis of primary degenerative dementia or multi-infarct dementia and were aged greater than or equal to 65 years. Twenty-two patients were given 150 mg fluvoxamine per day and 24 received placebo tablets; 14 and 15 patients, respectively, completed 6 weeks of treatment. Within treatments, there were no significant changes in median scores on neuropsychological tests (picture recall and recognition, trail making and finger tapping) or the GBS scale scores (degrees of dementia) or GBS subscale score (clinical profiles, including symptoms common in dementia, motor, emotional and intellectual functioning). Between treatments, the median changes in psychometric test scores did not differ significantly. However, within and between treatments, there were trends favoring fluvoxamine on symptoms common in dementia (confusion, irritability, anxiety, fear-panic, mood level and restlessness). In conclusion, the study does not support the hypothesis that fluvoxamine improves cognitive functioning or behavioral changes in elderly dementia patients.
This review finds no evidence that cannabinoids are effective in the improvement of disturbed behaviour in dementia or in the treatment of other symptoms of dementia. More randomized double-blind placebo controlled trials are needed to determine whether cannabinoids are clinically effective in the treatment of dementia.