Explore the vast range of titles available.

Dementia is a leading cause of death and disability worldwide. Here we tested the effectiveness of blood pressure (BP) reduction on the risk of all-cause dementia among 33,995 individuals aged ≥40 years with uncontrolled hypertension in rural China. We randomly assigned 163 villages to a non-physician community healthcare provider-led intervention and 163 villages to usual care. In the intervention group, trained non-physician community healthcare providers initiated and titrated antihypertensive medications according to a simple stepped-care protocol to achieve a systolic BP goal of <130 mm Hg and a diastolic BP goal of <80 mm Hg, with supervision from primary care physicians. Over 48 months, the net reduction in systolic BP was 22.0 mm Hg (95% confidence interval (CI) 20.6 to 23.4; P  < 0.0001) and that in diastolic BP was 9.3 mm Hg (95% CI 8.7 to 10.0; P  < 0.0001) in the intervention group compared to usual care. The primary outcome of all-cause dementia was significantly lower in the intervention group than in the usual care group (risk ratio: 0.85; 95% CI 0.76 to 0.95; P  = 0.0035). Additionally, serious adverse events occurred less frequently in the intervention group (risk ratio: 0.94; 95% CI 0.91 to 0.98; P  = 0.0006). This cluster-randomized trial indicates that intensive BP reduction is effective in lowering the risk of all-cause dementia in patients with hypertension. ClinicalTrials.gov: NCT03527719 . In the CRHCP-3 cluster-randomized trial, blood pressure reduction lowered the risk of all-cause dementia by 15% in 33,995 individuals with hypertension.

Background The Ginkgo biloba special extract, EGb 761® has been widely used in the treatment of neuropsychiatric disorders, including Alzheimer’s disease (AD). Methods To guide clinical practice in the Asian region, the Asian Clinical Expert Group on Neurocognitive Disorders compiled evidence‐based consensus recommendations regarding the use of EGb 761® in neurocognitive disorders with/without cerebrovascular disease. Results Key randomized trials and robust meta‐analyses have demonstrated significant improvement in cognitive function, neuropsychiatric symptoms, activities of daily living (ADL) and quality of life with EGb 761®versus placebo in patients with mild‐to‐moderate dementia. In those with mild cognitive impairment (MCI), EGb 761® has also demonstrated significant symptomatic improvement versus placebo. World Federation of Societies of Biological Psychiatry guidelines list EGb 761® with the same strength of evidence as acetylcholinesterase inhibitors and N‐methyl‐D‐aspartate (NMDA) antagonists e.g. memantine (Grade 3 recommendation; Level B evidence). Only EGb 761® had Level B evidence in improving cognition, behaviour, and ADL in both AD and vascular dementia patients. Safety analyses show EGb 761® to have a positive risk‐benefit profile. While concerns have been raised regarding a possible increased bleeding risk, several randomized trials and two meta‐analyses have not supported this association. Conclusions The Expert Group foresee an important role for EGb 761®, used alone or as an add‐on therapy, in the treatment of MCI and dementias, particularly when patients do not derive benefit from acetylcholinesterase inhibitors or NMDA antagonists. EGb 761® should be used in alignment with local clinical practice guidelines.

Study Objectives: We investigated the effectiveness of a lighting intervention tailored to maximally affect the circadian system as a nonpharmacological therapy for treating problems with sleep, mood, and behavior in persons with Alzheimer disease and related dementias (ADRD). Methods: This 14-week randomized, placebo-controlled, crossover design clinical trial administered an all-day active or control lighting intervention to 46 patients with ADRD in 8 long-term care facilities for two 4-week periods (separated by a 4-week washout). The study employed wrist-worn actigraphy measures and standardized measures of sleep quality, mood, and behavior. Results: The active intervention significantly improved Pittsburgh Sleep Quality Index scores compared to the active baseline and control intervention (mean ± SEM: 6.67 ± 0.48 after active intervention, 10.30 ± 0.40 at active baseline, 8.41 ± 0.47 after control intervention). The active intervention also resulted in significantly greater active versus control differences in intradaily variability. As for secondary outcomes, the active intervention resulted in significant improvements in Cornell Scale for Depression in Dementia scores (mean ± SEM: 10.30 ± 1.02 at baseline, 7.05 ± 0.67 after active intervention) and significantly greater active versus control differences in Cohen-Mansfield Agitation Inventory scores (mean ± SEM: −5.51 ± 1.03 for the active intervention, −1.50 ± 1.24 for the control intervention). Conclusions: A lighting intervention tailored to maximally entrain the circadian system can improve sleep, mood, and behavior in patients with dementia living in controlled environments. Clinical Trial Registration: Registry: ClinicalTrials.gov , title: Methodology Issues in a Tailored Light Treatment for Persons With Dementia, URL: https://clinicaltrials.gov/ct2/show/NCT01816152 , identifier: NCT01816152. Citation: Figueiro MG, Plitnick B, Roohan C, Sahin L, Kalsher M, Rea MS. Effects of a tailored lighting intervention on sleep quality, rest–activity, mood, and behavior in older adults with Alzheimer disease and related dementias: a randomized clinical trial. J Clin Sleep Med . 2019;15(12):1757–1767.

Depression is common in dementia but the evidence base for appropriate drug treatment is sparse and equivocal. We aimed to assess efficacy and safety of two of the most commonly prescribed drugs, sertraline and mirtazapine, compared with placebo. We undertook the parallel-group, double-blind, placebo-controlled, Health Technology Assessment Study of the Use of Antidepressants for Depression in Dementia (HTA-SADD) trial in participants from old-age psychiatry services in nine centres in England. Participants were eligible if they had probable or possible Alzheimer's disease, depression (lasting ≥4 weeks), and a Cornell scale for depression in dementia (CSDD) score of 8 or more. Participants were ineligible if they were clinically critical (eg, suicide risk), contraindicated to study drugs, on antidepressants, in another trial, or had no carer. The clinical trials unit at King's College London (UK) randomly allocated participants with a computer-generated block randomisation sequence, stratified by centre, with varying block sizes, in a 1:1:1 ratio to receive sertraline (target dose 150 mg per day), mirtazapine (45 mg), or placebo (control group), all with standard care. The primary outcome was reduction in depression (CSDD score) at 13 weeks (outcomes to 39 weeks were also assessed), assessed with a mixed linear-regression model adjusted for baseline CSDD, time, and treatment centre. This study is registered, number ISRCTN88882979 and EudraCT 2006-000105-38. Decreases in depression scores at 13 weeks did not differ between 111 controls and 107 participants allocated to receive sertraline (mean difference 1·17, 95% CI −0·23 to 2·58; p=0·10) or mirtazapine (0·01, −1·37 to 1·38; p=0·99), or between participants in the mirtazapine and sertraline groups (1·16, −0·25 to 2·57; p=0·11); these findings persisted to 39 weeks. Fewer controls had adverse reactions (29 of 111 [26%]) than did participants in the sertraline group (46 of 107, 43%; p=0·010) or mirtazapine group (44 of 108, 41%; p=0·031), and fewer serious adverse events rated as severe (p=0·003). Five patients in every group died by week 39. Because of the absence of benefit compared with placebo and increased risk of adverse events, the present practice of use of these antidepressants, with usual care, for first-line treatment of depression in Alzheimer's disease should be reconsidered. UK National Institute of Health Research HTA Programme.

The increasing global direct and indirect cost of dementia care reached 1.33 trillion USD in 2020 with a projected rise to 9.12 trillion USD by 2050. Sleep disturbances are prevalent in People Living With Dementia (PLWD) and Mild Cognitive Impairment (MCI), impacting on daily living, increasing carer burden, and potentially accelerating disease progression. Effective sleep management could improve independence, reduce carer burden, and mitigate long-term economic costs. However, little is known about how to effectively manage sleep in PLWD/MCI within primary care settings. Challenges stem from a complex interplay of contributing patient and practice factors including inappropriate long-term hypnotic usage, diverse individual experience and perception of needs, and limited access to effective non-pharmacological interventions. Effective sleep management for PLWD/MCI might however be improved with tailored, person-centred, care plans with the input of family carers, that address individual needs and circumstances and promote independence. We co-designed a Tailored Intervention for Managing Sleep (TIMES) with Patient and Public Involvement (PPI) groups and health and social care professionals. TIMES aims to support General Practitioners and other primary care staff, e.g. nurses, pharmacists, to provide person-centred care for PLWD and MCI, by addressing the multifaceted aspects of sleep disturbance. In preparation for evaluating the effectiveness of TIMES in a subsequent, full-scale, randomised controlled trial, we conducted a cluster-randomized feasibility trial in 10 GP practices in England, targeting 64 patient-carer dyads, including economic analysis. We will present key findings from the feasibility trial, highlighting (i) barriers and enablers to successful recruitment and retention of both GP practices and patient-carer dyads; (ii) intervention fidelity and acceptability within the primary care setting; (iii) preliminary outcomes of the TIMES intervention on patient sleep, quality of life, carer burden, costs and resource utilisation including medication, and primary care staff confidence in managing sleep disturbances in PLWD/MCI. We will discuss the implications of our findings for improving sleep management for PLWD/MCI within primary care settings. Findings from this feasibility trial will inform the design and deployment of a subsequent full-scale randomized controlled trial of the TIMES intervention.

Agitation is common in people with dementia and negatively affects the quality of life of both people with dementia and carers. Non-drug patient-centred care is the first-line treatment, but there is a need for other treatment when this care is not effective. Current evidence is sparse on safer and effective alternatives to antipsychotics. We assessed the efficacy and safety of mirtazapine, an antidepressant prescribed for agitation in dementia. This parallel-group, double-blind, placebo-controlled trial—the Study of Mirtazapine for Agitated Behaviours in Dementia trial (SYMBAD)—was done in 26 UK centres. Participants had probable or possible Alzheimer's disease, agitation unresponsive to non-drug treatment, and a Cohen-Mansfield Agitation Inventory (CMAI) score of 45 or more. They were randomly assigned (1:1) to receive either mirtazapine (titrated to 45 mg) or placebo. The primary outcome was reduction in CMAI score at 12 weeks. This trial is registered with ClinicalTrials.gov, NCT03031184, and ISRCTN17411897. Between Jan 26, 2017, and March 6, 2020, 204 participants were recruited and randomised. Mean CMAI scores at 12 weeks were not significantly different between participants receiving mirtazapine and participants receiving placebo (adjusted mean difference –1·74, 95% CI –7·17 to 3·69; p=0·53). The number of controls with adverse events (65 [64%] of 102 controls) was similar to that in the mirtazapine group (67 [66%] of 102 participants receiving mirtazapine). However, there were more deaths in the mirtazapine group (n=7) by week 16 than in the control group (n=1), with post-hoc analysis suggesting this difference was of marginal statistical significance (p=0·065). This trial found no benefit of mirtazapine compared with placebo, and we observed a potentially higher mortality with use of mirtazapine. The data from this study do not support using mirtazapine as a treatment for agitation in dementia. UK National Institute for Health Research Health Technology Assessment Programme.

AbstractObjectiveTo evaluate the feasibility and effectiveness of the CORDIAL program, a psychosocial intervention consisting of cognitive behavioral therapy (CBT), cognitive rehabilitation, and reminiscence to manage depressive symptoms for people with mild cognitive impairment (MCI) or dementia. DesignWe conducted a randomized controlled trial, based on a two-group (intervention and control), pre-/post-intervention design. SettingParticipants were recruited from five different old age psychiatry and memory clinics at outpatients’ hospitals. ParticipantsHundred and ninety-eight people with MCI or early-stage dementia were included. InterventionThe intervention group ( n = 100) received 11 individual weekly sessions of the CORDIAL program. This intervention includes elements from CBT, cognitive rehabilitation, and reminiscence therapy. The control group ( n = 98) received treatment-as-usual. MeasurementsWe assessed Montgomery–Åsberg Depression Rating Scale (MADRS) (main outcome), Neuropsychiatric Inventory Questionnaire, and Quality of Life in Alzheimer’s disease (secondary outcomes) over the course of 4 months and at a 10-month follow-up visit. ResultsA linear mixed model demonstrated that the depressive symptoms assessed by MADRS were significantly more reduced in the intervention groups as compared to the control group ( p < 0.001). The effect persisted for 6 months after the intervention. No significant differences between groups were found in neuropsychiatric symptoms or quality of life. ConclusionOur multicomponent intervention, which comprised 11 individual sessions of CBT, cognitive rehabilitation, and reminiscence therapy, reduced depressive symptoms in people with MCI and dementia.

Hearing and vision loss are common among residents with dementia (RwD) in long-term care (LTC) facilities, adversely affecting quality of life and dementia-related outcomes. Enhancing sensory function may improve these outcomes. The SENSE-Cog Residential Care pilot trial evaluated the feasibility of a comprehensive sensory intervention for RwD with hearing and vision loss and explored the potential for a definitive evaluation of sensory support programs in LTC. This pilot, feasibility, cluster-randomized controlled trial included nine LTC facilities in Ireland. Facilities were assigned to either \"care as usual\" (CAU) or a multi-component sensory intervention. The intervention comprised personalized hearing and vision support, staff training on sensory health, creation of a sensory-friendly environment, and mapping of sensory care provision. The trial assessed feasibility, acceptability, and tolerability among residents and staff, with exploratory outcomes for a future definitive trial. The primary goal was to inform the design of a large-scale trial. Data were collected on recruitment and retention rates, intervention uptake, safety, and data collection feasibility. Additional measures included the provision of hearing and vision assessments and devices, quality of life as an exploratory outcome, and staff feedback on training. Nine LTC facilities consented to participate. Of 42 RwD screened, 27 were recruited (13.5/month), with 26 retained at three months. In intervention facilities, all 12 residents received hearing and vision assessments, resulting in provision of glasses (12), hearing aids (4), and listening devices (6). Sensory-cognitive training was delivered to 42 staff, including in-depth sensory champion training for two staff per facility. Staff rated the training highly (TARS acceptability: M = 33.18; outcomes: M = 30). Environmental audits highlighted limited capacity for structural sensory changes. Data collection compliance exceeded 95%, with 75% of RwD wearing glasses, 50% using hearing aids, and 33% utilizing listening devices at follow-up. No safety concerns were reported. Recruitment, intervention uptake, and data collection in LTC facilities were feasible, and staff and resident participation was high. These findings support a full-scale randomized controlled trial to evaluate the efficacy of sensory interventions in LTC settings.

This study began as a single-blind randomized controlled trial (RCT) to investigate the efficacy and safety of electroconvulsive therapy (ECT) for severe treatment-refractory agitation in advanced dementia. The aims are to assess agitation reduction using the Cohen-Mansfield Agitation Inventory (CMAI), evaluate tolerability and safety outcomes, and explore the long-term stability of agitation reduction and global functioning. Due to challenges encountered during implementation, including recruitment obstacles and operational difficulties, the study design was modified to an open-label format and other protocol amendments were implemented. Initially, the RCT randomized participants 1:1 to either ECT plus usual care or simulated ECT plus usual care (S-ECT) groups. As patients were enrolled, data were collected from both ECT and simulated ECT (S-ECT) patients. The study now continues in an open-label study design where all patients receive actual ECT, reducing the targeted sample size from 200 to 50 participants. Study is ongoing and open to enrollment. The transition of the ECT-AD study design from an RCT to open-label design exemplifies adaptive research methodologies in response to real-world challenges. Data from both the RCT and open-label phases of the study will provide a unique perspective on the role of ECT in managing severe treatment-refractory agitation in dementia, potentially influencing future clinical practices and research approaches.

Dementia is among the leading causes of functional loss and disability in older adults. Research has demonstrated that nursing home patients without dementia can improve their function in activities of daily living, strength, balance and mental well being by physical exercise. The evidence on effect of physical exercise among nursing home patients with dementia is scarce and ambiguous. Thus, the primary objective of this study was to investigate the effect of a high intensity functional exercise program on the performance of balance in nursing home residents with dementia. The secondary objective was to examine the effect of this exercise on muscle strength, mobility, activities of daily living, quality of life and neuropsychiatric symptoms. This single blinded randomized controlled trial was conducted among 170 persons with dementia living in nursing homes. Mean age was 86.7 years (SD = 7.4) and 74% were women. The participants were randomly allocated to an intervention (n = 87) or a control group (n = 83). The intervention consisted of intensive strengthening and balance exercises in small groups twice a week for 12 weeks. The control condition was leisure activities. The intervention group improved the score on Bergs Balance Scale by 2.9 points, which was significantly more than the control group who improved by 1.2 points (p = 0.02). Having exercised 12 times or more was significantly associated with improved strength after intervention (p<0.05). The level of apathy was lower in the exercise group after the intervention, compared to the control group (p = 0.048). The results from our study indicate that a high intensity functional exercise program improved balance and muscle strength as well as reduced apathy in nursing home patients with dementia. ClinicalTrials.gov NCT02262104.