Active clinical trials for "Dementia"

"Adult safeguarding is everyone's responsibility". The Care Act 2014 makes safeguarding a legal duty. It provides local authorities and other agencies in England with a responsibility to protect adults with care and support needs from abuse and neglect. This is done most effectively when all relevant agencies work together. This is particularly important for people living with dementia, as they are at higher risk of abuse or neglect. Such abuse is most common in their own homes and care settings. Primary and social care professionals are likely to have regular contacts with older people, hence have opportunities for early identification and prevention of abuse. However, little is known about how primary care practitioners work in partnership with social care and other agencies to investigate and manage abuse. Aims: This project will outline how health professionals in primary care settings understand and respond to abuse and what their understandings of safeguarding law and policy are. It will also identify how social services departments assess and manage referrals relating to people living with dementia in primary care settings. Furthermore, the study will analyse the experiences of people with dementia and families who are at the centre of safeguarding Methods: This study has three phases. In phase 1, the investigators will synthesise current research and practice evidence to develop a theory of safeguarding conceptualisation and process. In phase 2, the investigators will analyse national statistics on safeguarding (NHS digital dataset), ageing and dementia data (English Longitudinal Study of Ageing) to understand patterns of reporting and how they vary across location, gender, ethnicity and time period. In phase 3, the investigators will interview GPs, social workers, safeguarding leads, independent advocates, people with dementia, family members, support workers, carers and other professionals who make or receive referrals via primary care. As part of phase 3 group discussions will also be conducted, in which professionals will come together to share their experiences, and will identify approaches for preventing abuse and collaboration amongst relevant agencies. Phase 3 will inform the development of complex case studies, drawing on data from phases 1 and 2. Impact: This study will help develop practice guidance for professionals, to aid multi-agency collaboration in safeguarding cases specific to dementia. This will be developed in consultation with the PPIE (Patient and Public Involvement and Engagement) members and practitioners. Videos will also be produced and plain English versions of case studies of complex safeguarding scenarios and strategies in consultation with safeguarding leads, law experts, training providers and other key stakeholders. Experts by experience (working with, caring for or living with dementia), will be able to guide the team with cultural nuances and appropriateness to ensure that the material developed is sensitive to all populations. An info graph/pictograph displaying signs of abuse, staying safe and what to do, aimed at people with dementia and family will be compiled. The investigators will liaise with national safeguarding leads so that this information can be displayed in GP clinics. Furthermore, the investigators will contact social responsibility personnel for supermarkets and discuss the potentials of wider circulation for displaying this information in stores.

There are evidence based processes for assessment and management of pain using pharmacologic and nonpharmacological approaches. These were reviewed and included within the Pain Management Clinical Practice Guideline (Pain Management CPG) recently developed by AMDA: The Society for Post-Acute and Long-Term Care Medicine. There are, however, many challenges to translating the use of Clinical Practice Guidelines into clinical settings. To overcome these challenges we developed and previously tested a theoretically based approach and merged this approach with the Pain Management CPG, which is referred to as the PAIN-CLINICAL PRACTICE GUIDELINE-USING THE EVIDENCE INTEGRATION TRIANGLE (PAIN-CPG-EIT). The PAIN-CPG-EIT involves a research nurse facilitator working with an identified community champion(s) and stakeholder team for 12 months to provide the following four components: Component I: Establishing and meeting monthly with a Stakeholder Team; Component II: Education of the staff; Component III: Mentoring and motivating the staff to address pain; Component IV: Ongoing evaluation of resident pain outcomes. Twelve communities will be included with 25 residents living with dementia and pain recruited from each community. Six communities will be randomized to treatment (PAIN-CPG-EIT) and six randomized to education only (EO) which involves providing the same education to staff as is done in Component II of PAIN-CPG-EIT. The primary aim of this study is to test the effectiveness of use of the PAIN-CPG-EIT to improve the assessment, diagnosis and management of pain and decrease pain intensity among nursing home residents living with dementia between baseline, 4 and 12 months and evaluate treatment fidelity. A secondary aim of the study is to consider differences in measurement, treatment and response to treatment between male and female and Black versus White residents living with dementia. Findings from this study will help build on the currently limited information about pain presentation and management among older adults living with dementia in nursing homes and improve health equity of aging populations experiencing pain.

This trial will assess feasibility of a non-pharmacological intervention for persons living with Alzheimer's disease and related dementias (ADRD) to improve behavioral and psychiatric symptoms of dementia and functional performance. Using a two-arm, prospective randomized controlled trial, 38 dyads (person with ADRD and caregiver) will complete an 8-week telehealth occupational therapy intervention provided via Zoom with caregivers and persons with dementia or receive an active control with 8 telehealth sessions to discuss publicly available caregiver education with a non-clinical research assistant.

The goal of this clinical trial is to demonstrate potential improvements in clinical trial methods relating to dementia and cognitive decline. The main questions it aims to answer are: Can an intervention's outcome be better assessed by a latent variable ("δ") integrating cognitive performance with functional status? Can latent biomarkers of δ guide the selection of an intervention that will modulate dementia severity? Can a latent variable, derived from information collected remotely from caregivers, preselect subjects most likely to respond to the intervention? Is the effect of the intervention in fact medicated by changes in the targeted biomarker? In this case, the biomarker will be a latent variable derived from several proteins measured in blood (i.e., so-called "adipokines"). The intervention will be donepezil, a medication approved for the treatment of Alzheimer's Disease, but only recently associated with adipokine changes. Participants with cognitive impairment and their caregivers will be interviewed by telephone and those with cognitive impairment will be treated for six-months with donepezil. On the basis of the caregiver's report, the cognitively impaired subjects will be assigned to two groups based on a prediction of their response to donepezil. Researchers will compare those groups to see if dementia severity, as measured by δ, improves in predicted responders, and whether the change in the d-score is mediated by changes in adipokines.

Sleep apnea is characterized by temporary pauses or stops to participant's breathing. Currently, sleep apnea is diagnosed using an in-lab sleep study, which involves spending a night in a sleep laboratory hooked up to wires on the head, chest, and legs. However, this is not feasible for many older adults. To overcome this barrier, the investigators will utilize an investigational vital signs monitor - the Advanced NeoNatal Epidermal (ANNE) Vital Sign System (Sibel Health, Evanston, IL,USA). The primary objective of this study is to test the hypothesis that sleep apnea is associated with accelerated cognitive decline in older adults at risk for dementia. The investigators will measure sleep apnea at baseline and 12 months later and relate this to cognitive function at the same time points. Sex-stratification will be used in analyses as appropriate. Qualitative feedback forms will be used to collect information about participant ease of use and experience with the ANNE Vital Sign System.

The greying of the world is leading to a rapid acceleration in both the healthcare costs and caregiver burden that are associated with dementia. There is an urgent need to develop new, easily scalable modalities of support to reduce agitation and anxiety in those with dementia. There is evidence that music interventions reduce agitation and anxiety in those with dementia. LUCID has developed a novel digital music therapeutic product that uses a reinforcement learning AI agent to curate and personalize the musical playlist while incorporating binaural theta auditory beat stimulation (ABS) to reduce anxiety and agitation in those with dementia. This study will be conducted remotely with study hardware (tablets and Bluetooth speakers) being shipped to caregivers/participants' homes. The study will take place over a 2-week period, with participants completing 4 one-hour sessions per week along with an additional 1-hour follow-up interview session. Forty-eight participants with mild to moderate dementia (as defined by the Montreal Cognitive Assessment) will be evenly randomized to one of two conditions. The control condition consists of a selection of 30-minute audiobooks which the participant has the freedom to select from. The experimental condition consists of music and binaural ABS curated by LUCID's AI system. Participants' caregivers will complete baseline questionnaires assessing the participants' anxiety, agitation, and mood. They will also complete these questionnaires before and after each experimental session. The investigators hypothesize that the LUCID AI music curation system will have a greater agitation and anxiety reduction compared to the audiobook control condition.

The purpose of this single arm study is to evaluate the feasibility and safety of treatments with a non-invasive neuromodulation device in adults diagnosed with mild/moderate Parkinson's disease dementia (PDD). A non-invasive device is a device that stays outside of the body and is not implanted and does not penetrate the skin. Neuromodulation means that the device stimulates activity in the brain.

The purpose of this study is to assess acceptability, and safety of providing tDCS to ADRD patients with behavioral symptoms and to assess the efficacy of tDCS for ADRD-related symptoms, mainly behavioral symptoms.

Cerebral small Vessel Disease (cSVD), characterized by an alteration of the structure and function of small penetrating brain arteries, is highly prevalent in older persons from the general population and represents a leading cause of stroke and a major contributor to cognitive decline and dementia risk. In France >4 million persons aged 60+ are estimated to have moderate to extensive covert cSVD (ccSVD), i.e. features of SVD on brain imaging without a history of clinical stroke. Better detection and management of covert cSVD would have a major impact on preventing disability and costs related to stroke, cognitive impairment and dementia. However, there are no specific mechanistic treatments for cSVD and hardly any recommendations worldwide on how to prevent and treat cSVD and related cognitive impairment. The aim of the present study, through the identification of novel cutting-edge multimodal biomarkers, is to develop innovative diagnostic and risk prediction tools for cSVD and its complications and to contribute to accelerating the discovery of novel drug targets and therapeutics strategies for cSVD.

This is a randomized, cross-over study to measure global and clinical impact and level of arousal in subjects suffering from moderate to severe Alzheimer's disease when exposed to emotionally impactful music compared to control intervention.