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NCT06683443
Robotic pets can provide a source of affection and companionship for patients. This is especially important as individuals with dementia may receive infrequent visitation from family members if their families struggle with how to cope and communicate with their loved one. Several options such as the "Joy for All™" and "Paro" robotic pets offer a source of companionship that is both interactive and comforting. Sarasota Memorial Health Care System (SMHCS) researchers are seeking to make companion pets available to patients with dementia to provide them with a supplemental enrichment experience that enhances their overall care and lowers their risk for superimposed delirium. The intervention will consist of providing a robotic pet to the patient within 48 hours of admission, which the patient will keep with them throughout their hospital stay and upon discharge. SMHCS researchers will evaluate the effects of the robotic pet interaction on patient delirium scores, as measured by the Nursing Delirium Screening Scale (Nu-DESC), length of stay, and the use of intravenous psychotropic medications, code greys, falls occurrence, restraint use, and IV dislodgement in patients with mild-to-moderate dementia. The Nu-DESC scale is a short assessment tool, estimated to take approximately 3-5 minutes to complete and is already part of standard care at SMHCS. This tool is used by nursing staff with minimal additional training and shows consistent sensitivity (85.7%) and specificity (86.8%) in detecting delirium. The NuDESC score may be positive in a patient with dementia, since some characteristics of dementia can be similar to delirium. However, patients with dementia are at higher risk for developing delirium, so the NuDESC is a helpful tool for the nurse. A score of 2 or higher is considered screening positive for delirium. For this study, the NuDESC tool will be used as a guideline to assist in the screening of delirium. The patients will have to score a 4 or less to be included in the study. Patients that are scoring \>4 will be excluded. Theoretic Framework of Acceptability (TFA) is a questionnaire which will be used to assess health care provider acceptability of the companion animal. This tool is currently not in use at SMHCS, but it will be used as part of this study to assess whether health care providers accept (or reject) the robotic pets as companion animals.
NCT04246437
Alpha-synucleinopathies refer to age-related neurodegenerative and dementing disorders, characterized by the accumulation of alpha-synuclein in neurons and/or glia. The anatomical location of alpha-synuclein inclusions (Lewy Bodies) and the pattern of progressive neuronal death (e.g. caudal to rostral brainstem) give rise to distinct neurological phenotypes, including Parkinson's disease (PD), Multiple System Atrophy (MSA), Dementia with Lewy Bodies (DLB). Common to these disorders are the involvement of the central and peripheral autonomic nervous system, where Pure Autonomic Failure (PAF) is thought (a) to be restricted to the peripheral autonomic system, and (b) a clinical risk factor for the development of a central synucleinopathy, and (c) an ideal model to assess biomarkers that predict phenoconversion to PD, MSA, or DLB. Such biomarkers would aid in clinical trial inclusion criteria to ensure assessments of disease- modifying strategies to, delay, or halt, the neurodegenerative process. One of these biomarkers may be related to the neurotransmitter dopamine (DA) and related changes in the substantia nigra (SN) and brainstem. \[18F\]F-DOPA is a radiolabeled substrate for aromatic amino acid decarboxylase (AAADC), an enzyme involved in the production of dopamine. Use of this radiolabeled substrate in positron emission tomography (PET) may provide insight to changes in monoamine production and how they relate to specific phenoconversions in PAF patients. Overall, this study aims to identify changes in dopamine production in key regions including the SN, locus coeruleus, and brainstem to distinguish between patients with PD, MSA, and DLB, which may provide vital information to predict conversion from peripheral to central nervous system disease.
NCT07123077
This study aims to explore how a functional exercise program, with or without music, affects physical function and quality of life in older adults with mild dementia. Participants were divided into two groups: one group performed functional exercises alone, while the other group performed the same exercises accompanied by music. The program was conducted twice a week for 8 weeks, with each session lasting 60 minutes. Researchers evaluated changes in balance, mobility, risk and fear of falling, hand grip strength, daily living activities, and overall quality of life before and after the program.
NCT05508789
The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.
NCT07461168
Care partners of people living with dementia often experience ongoing stress and unmet support needs. This study evaluates the feasibility of a low-intensity, supportive education and resource intervention for care partners who previously participated in an observational study. Participants complete a baseline phone interview and a short stress journaling activity, followed by a six-week series of automated educational and supportive messages delivered by text message or email. Participants may also take part in an optional peer support focus group. The study examines caregiver stress, resilience, engagement with resources, and participant feedback to inform future caregiver support interventions.
NCT07279103
This study aims to examine the effects of a multisensory environment-based occupational therapy intervention on sensory processing, cognitive status, behavioral and psychological symptoms, and caregiver burden in individuals diagnosed with Alzheimer's disease. Non-pharmacological approaches in Alzheimer's management have been shown to slow functional decline, reduce behavioral symptoms, and improve caregivers' well-being. Multisensory environments provide visual, auditory, tactile, proprioceptive, vestibular, olfactory, and gustatory stimuli to support sensory integration and enhance engagement, particularly in individuals with cognitive and communication difficulties. The study will be conducted using a randomized controlled design and will include individuals aged 65 years and older with moderate-stage Alzheimer's disease and their primary caregivers. The intervention will be implemented over four weeks with two sessions per week. Outcome measures will include the Adult/Adolescent Sensory Profile,Loewenstein Occupational Therapy Cognitive Assessment-Geriatric version, Neuropsychiatric Inventory, and Zarit Caregiver Burden Inventory. The study is expected to contribute to the evidence base supporting sensory-based occupational therapy interventions in dementia care.
NCT04404153
The prevalence of Alzheimer's Disease (AD) is rising, but existing medications provide only modest control of cognitive decline and associated symptoms, and novel therapies are urgently needed. This randomized sham-controlled trial will determine if an innovative low-risk remotely-supervised transcranial Direct Current Stimulation (tDCS) applied over the area of the dorsolateral prefrontal cortex for 30 minutes at the intensity of 2 mA five times per week for 6 months at home can improve cognitive performance and symptoms and modulate neuroimaging markers of neuroplasticity in 100 patients with mild to moderate AD. If effective, this novel intervention can substantially enhance AD symptom management at home, improve quality of life of AD patients and their families, and reduce burden associated with this debilitating illness.
NCT04863495
This is a longitudinal study with regular quantitative assessments of all participants every six months for 3 years. The quantitative portion of the study will recruit couples, consisting of individuals over the age of 65 who are in a committed relationship. Both members of the couple must be willing to participate at baseline. The assessment is in two parts. In the first part, each member of the couple will be asked the following: demographic information, mental health history, self-reported physical and emotional health, measures of emotional and mental health, personality, relationship and attachment style, social support and self-efficacy. Then each member of the study couple will be asked a series of questions to determine whether they consider themselves a caregiver. If they do, individuals will be asked to respond to additional caregiver questionnaires. Follow-ups will occur every six months for the study couples for a total of three years from the baseline visit. Each visit, the entire assessment except for demographic questions, will be re-administered to each individual in the couple. At the end of each questionnaire battery, individuals will be screened for cognitive impairment and those who are in the middle to advanced stages of dementia will no longer participate. Recruitment will end when 600 individuals (300 couples,150 couples at each site) are enrolled in the longitudinal portion of the study. All study visits will be conducted virtually via Zoom or WebEx video conferencing. Analyses will be conducted to determine the association between changes in dyadic relationship and changes in mental health and cognitive outcomes, to elucidate how relationship characteristics impact health and well-being as perceived by each member of the dyad.
NCT05978804
The primary objective of this research is to evaluate the effects of non-invasive brain stimulation and computerized cognitive training on executive functioning in individuals with Primary Progressive Aphasia (PPA), mild cognitive impairment (MCI), or dementia. In this study, investigators will use transcranial direct current stimulation (tDCS) to stimulate the left dorsolateral prefrontal cortex (DLPFC). Previous studies have demonstrated that tDCS over the DLPFC led to improvements in attention deficit caused by stroke, Parkinson's Disease, and major depression as well as language deficits caused by neurodegenerative conditions such as primary progressive aphasia or mild cognitive impairment. The investigators seek to expand on this literature by investigating how anodal tDCS paired with and without cognitive training will impact executive functioning in PPA with Frontotemporal Dementia or Alzheimer's Disease pathology and Mild Cognitive Impairment/Alzheimer's Disease (e.g. shifting, updating, monitoring, and manipulation).
NCT05522387
The goal of this Phase 2 Open Label study is to evaluate long-term safety, tolerability, and efficacy of XPro1595 on measures of cognition, function and brain quality in individuals with Alzheimer's Disease.
NCT07314190
This is a retrospective observational study to evaluate the clinical utility of blood-based biomarkers in the diagnosis and management of patients with a neurodegenerative disease (ND) or mental disorder (MD).
NCT05858996
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.
NCT07422857
This study is to evaluate the efficacy and safety of \[18F\]-APN-1607 Injection in PET imaging for detecting AD-related cognitive impairment.
NCT05977712
The CIRCAME study is a bicentric study of patients from 2 memory clinics in Paris. The main objective is to identify circadian rhythm components and other individual risk factors (sociodemographic, behavioral, and health related factors) associated with the diagnosis of subtypes (AD, Lewy bodies, vascular, frontotemporal dementia) and stages (cognitively healthy, mild cognitive impairment, clinical dementia) of dementia, independent of known risk factors (sociodemographic and genetic) and assess the relevance of use of these factors in primary care for screen of dementia including subtypes and stages. A secondary objective is to determine factors associated with progression of the disease, in terms of cognitive decline and limitations in activities of daily living, as well as progression to dementia among cognitively healthy controls and patients with mild cognitive impairment, up to 15 years after the inclusion period.
NCT03789760
As a traditional Chinese medicine compound, SaiLuoTong capsule is proven to have beneficial effects on learning and memory ability in animal models of vascular dementia (VaD). According to the result of the phase II study, the efficacy of SaiLuoTong capsule in the treatment of patients with VaD was better than that of placebo group and no difference in safety. So the study hypothesis is also that SaiLuoTong capsule will be effective in the treatment of patients with VaD and will be well tolerated. The purpose of the study is to confirm the efficacy and safety of SaiLuoTong capsule on patients with mild to moderate VaD. The outcome measures include general cognitive function, executive function, daily living skills, and mental behavior changes of symptoms in VaD patients.
NCT06276023
Building on limitations of prior research, the investigators developed the Mindful and Self-Compassionate Care Program (MASC) to help caregivers of persons with Alzheimer Disease and Related Dementias (ADRD) manage stress associated with the general caregiver experience including stress stemming from managing challenging patient behaviors. MASC teaches: (1) mindfulness skills; (2) compassion and self-compassion skills; and (3) behavioral management skills. MASC also provides psychoeducation and group-based training and skill practice to facilitate skill uptake and integration within the caregiver experience and tasks. The main aim is to: Demonstrate feasibility, acceptability, credibility, fidelity, preliminary efficacy and evidence for proposed mechanism of MASC through a pilot randomized controlled trial. Relevant stakeholders (caregivers of persons with ADRD) will participate in the intervention.
NCT01760005
The purpose of this study is to assess the safety, tolerability, biomarker, cognitive and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive/clinical impairment or improves disease-related biomarkers.
NCT06021704
Care for America's Aging is a randomized pilot study investigating whether a home health aide training intervention consisting of enhanced dementia-specific curriculum content will improve: 1) behavioral symptoms of older adult persons living with dementia or cognitive impairment (PLWD/CI) and 2) global health-related quality of life among PLWD/CI and their care partners.
NCT03750409
This study will gather data to see if infrared and near infrared light frequency can increase the activity of brain cells and provide support for the cell's ability to repair and protect themselves against further damage.
NCT03682081
The overall purpose of this project is to develop effective dysphagia rehabilitative interventions for patients with Alzheimer's Disease and related dementias at risk for pneumonia development.