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"Dementia - therapy"
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Trial of Pimavanserin in Dementia-Related Psychosis
The serotonin-receptor modulator pimavanserin reduces psychosis in patients with Parkinson’s disease. In a randomized discontinuation trial involving patients with psychosis related to several types of dementia, the frequency of relapse over a period of 26 weeks was 13% with pimavanserin and 28% with placebo.
Journal Article
Caring for Aged Dementia Care Resident Study (CADRES) of person-centred care, dementia-care mapping, and usual care in dementia: a cluster-randomised trial
Evidence for improved outcomes for people with dementia through provision of person-centred care and dementia-care mapping is largely observational. We aimed to do a large, randomised comparison of person-centred care, dementia-care mapping, and usual care.
In a cluster randomised controlled trial, urban residential sites were randomly assigned to person-centred care, dementia-care mapping, or usual care. Carers received training and support in either intervention or continued usual care. Treatment allocation was masked to assessors. The primary outcome was agitation measured with the Cohen-Mansfield agitation inventory (CMAI). Secondary outcomes included psychiatric symptoms including hallucinations, neuropsychological status, quality of life, falls, and cost of treatment. Outcome measures were assessed before and directly after 4 months of intervention, and at 4 months of follow-up. Hierarchical linear models were used to test treatment and time effects. Analysis was by intention to treat. This trial is registered with the Australia and New Zealand Clinical Trials Registry, number ACTRN12608000084381.
15 care sites with 289 residents were randomly assigned. Pairwise contrasts revealed that at follow-up, and relative to usual care, CMAI score was lower in sites providing mapping (mean difference 10·9, 95% CI 0·7–21·1; p=0·04) and person-centred care (13·6, 3·3–23·9; p=0·01). Compared with usual care, fewer falls were recorded in sites that used mapping (0·24, 0·08–0·40; p=0·02) but there were more falls with person-centred care (0·15, 0·02–0·28; p=0·03). There were no other significant effects.
Person-centred care and dementia-care mapping both seem to reduce agitation in people with dementia in residential care.
Australian Health Ministers' Advisory Council.
Journal Article
Predictors of primary care psychological therapy outcomes for depression and anxiety in people living with dementia: evidence from national healthcare records in England
Psychological therapies can be effective in reducing symptoms of depression and anxiety in people living with dementia (PLWD). However, factors associated with better therapy outcomes in PLWD are currently unknown.
To investigate whether dementia-specific and non-dementia-specific factors are associated with therapy outcomes in PLWD.
National linked healthcare records were used to identify 1522 PLWD who attended psychological therapy services across England. Associations between various factors and therapy outcomes were explored.
People with frontotemporal dementia were more likely to experience reliable deterioration in depression/anxiety symptoms compared with people with vascular dementia (odds ratio 2.98, 95% CI 1.08-8.22;
= 0.03) or Alzheimer's disease (odds ratio 2.95, 95% CI 1.15-7.55;
= 0.03). Greater depression severity (reliable recovery: odds ratio 0.95, 95% CI 0.92-0.98,
< 0.001; reliable deterioration: odds ratio 1.73, 95% CI 1.04-2.90,
= 0.04), lower work and social functioning (recovery: odds ratio 0.98, 95% CI 0.96-0.99,
= 0.002), psychotropic medication use (recovery: odds ratio 0.67, 95% CI 0.51-0.90,
= 0.01), being of working age (recovery: odds ratio 2.03, 95% CI 1.10-3.73,
= 0.02) and fewer therapy sessions (recovery: odds ratio 1.12, 95% CI 1.09-1.16,
< 0.001) were associated with worse therapy outcomes in PLWD.
Dementia type was generally not associated with outcomes, whereas clinical factors were consistent with those identified for the general population. Additional support and adaptations may be required to improve therapy outcomes in PLWD, particularly in those who are younger and have more severe depression.
Journal Article
Baseline task performance predicts mini-mental state examination improvement after individuals with dementia practice an N-back task with bilateral transcranial direct current stimulation
This research explores the relationship between baseline performance in dementia patients and its impact on the effectiveness of transcranial direct current stimulation (tDCS) for improving executive function. Past research suggests that those participants who are more impaired at baseline will be those who then demonstrate the greatest improvements with tDCS. In addition, we examined if bilateral or unilateral stimulation would be more effective for improving the general level of cognition of these participants.
The study involved 24 participants, with 18 diagnosed with Alzheimer's disease (AD) and 6 with Frontotemporal Dementia (FTD). These participants engaged in three rounds of N-back task training sessions, each separated by two months. The sessions included three types of stimulation: 4mA unilateral stimulation targeting the left Dorsolateral Prefrontal Cortex (DLPFC), 4mA bilateral stimulation targeting both the left and right DPFC, and sham stimulation. Additionally, a control group of elderly individuals without dementia was used to establish a benchmark for the normal average response time (RT) of the administered N-Back task. Evaluations, comprising of the N-Back task and the Mini-Mental State Examination (MMSE), were conducted before stimulation, at the final session, and two weeks post-stimulation in all rounds.
Participants were retrospectively allocated into those whose baseline N-Back response times (RTs) were found on average to be within the normal range versus those who performed more slowly than the normal range. For the group that performed within the normal range, no significant improvement was observed on the N-Back task after a series of sessions involving active tDCS. In contrast, the participants with slower than normal RTs at baseline demonstrated improvement both on the N-Back task (faster times) and the MMSE (higher scores) after receiving active tDCS, although accompanying improvement on the MMSE task was restricted to the condition where participants received bilateral tDCS.
This study replicates a pervasive finding in the tDCS literature: participants who perform worse at baseline often demonstrate the greatest improvements with tDCS. Furthermore, these results have clinical implications, in that tDCS may be most beneficial in individuals when clear deficits or impairments are present. Attempts to treat less severe participants might fail to show improvement with tDCS. Ultimately, baseline condition should be routinely considered when evaluating tDCS results.
Journal Article
Electroconvulsive therapy for the acute management of severe agitation in dementia (ECT-AD): A modified study protocol
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.
Journal Article
Maintenance cognitive stimulation therapy for dementia: single-blind, multicentre, pragmatic randomised controlled trial
There is good evidence for the benefits of short-term cognitive stimulation therapy for dementia but little is known about possible long-term effects.
To evaluate the effectiveness of maintenance cognitive stimulation therapy (CST) for people with dementia in a single-blind, pragmatic randomised controlled trial including a substudy with participants taking acetylcholinesterase inhibitors (AChEIs).
The participants were 236 people with dementia from 9 care homes and 9 community services. Prior to randomisation all participants received the 7-week, 14-session CST programme. The intervention group received the weekly maintenance CST group programme for 24 weeks. The control group received usual care. Primary outcomes were cognition and quality of life (clinical trial registration: ISRCTN26286067).
For the intervention group at the 6-month primary end-point there were significant benefits for self-rated quality of life (Quality of Life in Alzheimer's Disease (QoL-AD) P = 0.03). At 3 months there were improvements for proxy-rated quality of life (QoL-AD P = 0.01, Dementia Quality of Life scale (DEMQOL) P = 0.03) and activities of daily living (P = 0.04). The intervention subgroup taking AChEIs showed cognitive benefits (on the Mini-Mental State Examination) at 3 (P = 0.03) and 6 months (P = 0.03).
Continuing CST improves quality of life; and improves cognition for those taking AChEIs.
Journal Article
Non-literacy biased, culturally fair cognitive detection tool in primary care patients with cognitive concerns: a randomized controlled trial
Dementia is often undiagnosed in primary care, and even when diagnosed, untreated. The 5-Cog paradigm, a brief, culturally adept, cognitive detection tool paired with a clinical decision support may reduce barriers to improving dementia diagnosis and care. We performed a randomized controlled trial in primary care patients experiencing health disparities (racial/ethnic minorities and socioeconomically disadvantaged). Older adults with cognitive concerns were assigned in a 1:1 ratio to the 5-Cog paradigm or control. Primary outcome was improved dementia care actions defined as any of the following endpoints within 90 days: new mild cognitive impairment syndrome or dementia diagnoses as well as investigations, medications or specialist referrals ordered for cognitive indications. Groups were compared using intention-to-treat principles with multivariable logistic regression. Overall, 1,201 patients (mean age 72.8 years, 72% women and 94% Black, Hispanic or Latino) were enrolled and 599 were assigned to 5-Cog and 602 to the control. The 5-Cog paradigm demonstrated threefold odds of improvement in dementia care actions over control (odds ratio 3.43, 95% confidence interval 2.32–5.07). No serious intervention-related adverse events were reported. The 5-Cog paradigm improved diagnosis and management in patients with cognitive concerns and provides evidence to promote practice change to improve dementia care actions in primary care.
ClinicalTrials.gov:
NCT03816644
.
The 5-Cog paradigm, a culturally fair and non-literacy biased cognitive detection tool paired with a clinical decision support improved cognitive impairment diagnosis and management threefold in primary care patients with cognitive concerns.
Journal Article