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Dementia, Vascular clinical trials

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NCT ID: NCT04498962 Not yet recruiting - Vascular Dementia Clinical Trials

The Effect of Danzhu Fuyuan Granule as Adjunctive Therapy for Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy: A Bayesian Basket Trial

Start date: August 2020
Phase: N/A
Study type: Interventional

This study is designed as a bayesian basket trial , which aims to evaluate the efficacy of Danzhu Fuyuan Granule in patients with Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy

NCT ID: NCT04428112 Completed - Depression Clinical Trials

Rural Dementia Caregiver Project

Start date: June 5, 2020
Phase: N/A
Study type: Interventional

These caregivers are a vulnerable group due to their physical isolation and well-documented rural disparities in health care access and quality. Many rural dementia caregivers experience serious health consequences due to caregiving responsibilities that can limit their ability to maintain their caregiving role. Thus, there is a pressing need for effective, scalable, and accessible programs to support rural dementia caregivers. Online programs offer a convenient and readily translatable option for program delivery because they can be accessed by caregivers in the home and at the convenience of the user. Building Better Caregivers is an online 6-week, interactive, small-group self-management, social support, and skills-building workshop developed for caregivers of individuals with Alzheimer's disease or related dementia. The investigators will conduct a hybrid effectiveness-implementation randomized controlled trial that will enroll and randomize 640 rural dementia caregivers into two groups: the intervention (workshop) group and the attention control group. Caregivers will be recruited throughout the United States. Primary outcomes will be caregiver stress and depression symptoms. The investigators hypothesize that stress scores and depression symptoms will be significantly improved at 12 months in the intervention group versus control group. The investigators will also identify key strengths (facilitators) and weaknesses (barriers) of workshop implementation. The investigators will use the RE-AIM implementation framework and a mixed methods approach to identify implementation characteristics pertinent to both caregivers and rural community organizations. If the Building Better Caregivers workshop is proven to be effective, this research has the potential to open new research horizons, particularly on how to reach and effectively support isolated dementia caregivers in rural areas with an intervention that is scalable, even in low-resourced settings. If the workshop can achieve its goals with rural dementia caregivers, some of those most isolated, it would also be expected to be scalable in other low-resourced settings (e.g., in urban or suburban environments).

NCT ID: NCT04413851 Completed - Alzheimer Disease Clinical Trials

Feasibility of Passive Data Collection in Dementia Subjects With Agitation

Start date: June 1, 2020
Phase:
Study type: Observational

This is a multi-center, observational, feasibility study, to evaluate long term passive data collection, data quality, and user experience of HealthMode Agitation (Apps) to collect motion, location, physiological, and audio data; and eCOA and EMA responses with mobile devices (iPhone, Apple Watch). The purpose of this study is to evaluate and improve HealthMode Apps data collection and usability in subjects experiencing agitation in the context of dementia.

NCT ID: NCT04360200 Recruiting - Alzheimer Disease Clinical Trials

Cognitive Impairment in Ageing People

Start date: April 1, 2020
Phase:
Study type: Observational

Mild cognitive impairment (MCI) and neurocognitive disorder such as Alzheimer's disease (AD) and Vascular dementia (VaD) have become common diseases in the elderly. The burden of dementia is rising in China, with major medical, social and economic impacts. To address this important public health problem, cohort study on elderly cognitive disorders should be carry out. The methods of early prevention, early diagnosis and early treatment the cognitive disorders in elderly should be found to reduce the burden of the social and economic issue due to dementia. At present, the international corresponding guidelines have taken gene and brain imaging biomarkers as important indicators of dementia pathogenesis research, accurate diagnosis and targeted intervention. The study will construct a prospective cohort to establish database that provide not only comprehensive epidemiological data on the MCI and neurocognitive disorder in ageing people, but also complete the construction of biological samples bank and clinical diagnosis and treatment information database. Using the database, the study will identify the conversion rates from MCI to dementia and risk factors for the progression from MCI to dementia or AD. The study will also apply and develop brain structural and pathological imaging technology to support precision diagnosis of senile cognitive disorders. The study have goals to identify and validate imaging and blood/CSF biomarkers for the early detection and tracking of cognitive disorders.

NCT ID: NCT04337255 Recruiting - Stroke Clinical Trials

Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet in Stroke Patients Patients

Start date: December 14, 2021
Phase: N/A
Study type: Interventional

To test the effects of a 2- to 3-year intervention of the MIND diet versus usual post-stroke care on cognitive decline, the characteristic feature of dementia, and on brain biomarkers of Alzheimer's Disease (AD) and vascular disease in a Phase Ill randomized controlled trial of 500 patients hospitalized for acute ischemic stroke, aged 55 years or older, and without dementia who are discharged home following hospitalization.

NCT ID: NCT04335994 Recruiting - Alzheimer Disease Clinical Trials

ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing

ENCHANT
Start date: September 23, 2019
Phase: N/A
Study type: Interventional

Obstructive sleep apnea (OSA), which causes abnormal pauses in breathing during sleep, is common in patients with vascular cognitive impairment (VCI) and Alzheimer's disease (AD), and exacerbates the cognitive deficits seen in these conditions. OSA is typically treated with continuous positive airway pressure (CPAP), which has been shown to improve cognition in VCI and slow cognitive decline in AD. Despite the need to identify OSA in patients with VCI/AD, these patients often do not undergo testing for OSA. One major barrier is that in-laboratory polysomnography (iPSG), the current standard for diagnosing OSA, is inconvenient for patients with VCI/AD who may be reliant on others for care or require familiar sleep environments. A convenient and cheaper alternative to iPSG is home sleep apnea testing (HSAT), which has been validated against iPSG to diagnose OSA and has proven feasible for use in VCI/AD. Our primary objective is to determine whether the use of HSAT is superior to iPSG in terms of the proportion of patients who complete sleep testing by 6 months post-randomization. We will also investigate cost-effectiveness, patient satisfaction, proportion of patients treated with CPAP, changes in cognition, mood, sleep-related and functional outcomes between HSAT and iPSG at 6 months.

NCT ID: NCT04315337 Recruiting - Alzheimer Disease Clinical Trials

Improving Everyday Task Performance Through Repeated Practice in Virtual Reality.

VKI
Start date: January 12, 2021
Phase: N/A
Study type: Interventional

There are very few effective interventions that promote functional independence in people with Alzheimer's disease (AD) and related dementias. This R21 project is the first step in the long-term goal of developing an effective, enjoyable, portable, and inexpensive non-immersive virtual reality (VR) training intervention for improving the performance of everyday tasks. The investigators' VR training approach is built upon the results of past studies that show 1) when people with AD repeatedly practice daily tasks they subsequently perform them more completely and without error; and 2) healthy people are able to transfer skills learned in VR-contexts to tasks in the real world. This R21 study will obtain preliminary data to inform a future randomized clinical trial through three aims: Aim 1) To test the hypothesis that individuals with mild-moderate AD will show improved performance on an everyday task after repeatedly practicing the task in a non-immersive VR setting; Aim 2) To explore usability and acceptability of the VR training as well as associations between individual differences variables (e.g., cognitive abilities, demographics) and training effects. To test Aim 1, 40 participants with mild to moderate AD will be recruited to complete daily VR Training sessions for one week. VR Training will include repeated practice of a single, everyday task in a non-immersive VR-context (VR Breakfast or VR Lunch; counterbalanced across participants). The primary outcome measure is performance of the real-life version of the trained task, which will be collected before and at two time points after training, compared to performance of an untrained, control task of comparable difficulty, and scored from video by coders blinded to training task/condition. To evaluate Aim 2, all participants and an informant will complete interviews and questionnaires and participants will complete tests of cognitive abilities. Usability and acceptability of the VR training will be evaluated and associations between participant variables and VR Training results will be explored. If the proposed hypothesis is supported and results show that training effects generalize from virtual to real tasks in the study sample, then VR training of custom and individualized tasks will be investigated in a future randomized, controlled clinical trial for maintaining and improving functional abilities in people with mild to moderate AD.

NCT ID: NCT04313582 Recruiting - Dementia Clinical Trials

Feasibility of the SmartPrompt for Improving Everyday Function in Dementia

SmartPrompt
Start date: March 13, 2020
Phase: N/A
Study type: Interventional

Difficulty completing everyday tasks is a primary reason for the high cost of care, loss of caregiver paid hours, and general caregiver burden associated with dementia. Electronic reminder applications hold promise as a low-cost solution to improve daily functioning, promote aging in place, and reduce caregiver burden and cost of care, particularly as older adults become more computer literate. There are many electronic reminders available for healthy individuals, but few have been developed to target the specific cognitive difficulties that impede completion of everyday tasks in people with dementia (i.e., premature decay of task goals, decreased motivation to perform tasks, distractibility, semantic knowledge degradation, etc.). Furthermore, there is a dearth of feasibility research on the fundamental efficacy and usability of reminder applications for people with dementia. This R21 proposal addresses these gaps with a feasibility study of the SmartPrompt, an enhanced electronic reminder aid designed for people with dementia that is used with an inexpensive smartphone. A diverse sample of older adults with mild dementia (N = 40) and their caregivers (N =40) will be trained to use the SmartPrompt and then asked to use the application to perform a target task (hydration, meals, or medication) twice per day in their homes for two weeks. Aim 1 will test the hypothesis that the SmartPrompt is effective at promoting everyday task completion (i.e., efficacy) relative to a one- week control period without the SmartPrompt. Using a single-group crossover design, efficacy outcomes will be obtained during the SmartPrompt and Control Conditions and will include participant and caregiver reports of task completion, caregiver report of burden, and participant report of frustration Aim 2 will investigate whether the SmartPrompt will be perceived favorably by participants and caregivers and the extent to which technical support is needed for its use (i.e., usability). Usability measures will be obtained from caregivers (report of technical problems, questionnaire), participants (questionnaire), the study team (training time, technical support required), and the smartphone (i.e., measures of smartphone use, response times to prompts). A third exploratory aim is to examine participant and caregiver features that are associated with efficacy and usability outcomes, including participant cognitive profile, participant/caregiver demographics, computer proficiency and self-efficacy, desire to change, etc. Results will be used to inform 1) a working model of barriers and facilitators for the use and efficacy of prompting applications that may be tested in future studies and 2) SmartPrompt design modifications for a future Phase II clinical trial.

NCT ID: NCT04287738 Completed - Alzheimer Disease Clinical Trials

Care Ecosystem: Navigating Patients and Families Through Stages of Care, Extension Trial

Start date: March 20, 2015
Phase: N/A
Study type: Interventional

This is an extension trial of a prior trial (NCT02213458). Both persons with dementia (PWD) and their caregivers were enrolled as dyads. The purpose of this randomized clinical trial is to evaluate the benefits of a program that supports model care for PWD and their caregivers. Whereas the prior trial only delivered care and examined outcomes up to 12-months, this trial extends care and outcome measurement for 5 years or until death, and includes all dyads where the caregiver reported high caregiver burden (Zarit-12 greater than or equal to 17) at pre-randomization baseline for the original trial. Participants were recruited from California, Nebraska and Iowa. Participants determined to be eligible were consented and randomized into one of two groups. Two thirds of dyads were enrolled into Navigated Care that provided them with phone-based assistance in meeting important benchmarks in their care, for example completion of legal and financial planning and strategies for minimizing caregiver burden. One third of dyads were enrolled to a control group, entitled Survey of Care. Outcomes were unchanged from the original trial except for the addition of time to long term care placement and are detailed below.

NCT ID: NCT04248270 Not yet recruiting - Dementia Clinical Trials

A Noval Tau Tracer in Young Onset Dementia

Start date: February 20, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Dementia is a clinical syndrome which characterized by progressive cognitive impairment, behavior disturbance and dysfunction of daily activity. In aging population, Alzheimer's dementia (AD) is the most common late onset dementia which occupied about 50-75%, the vascular dementia, frontotemporal lobardegeneration (FTLD) and corticobasal syndrome is followed. On the other hand, the young onset dementia (YOD), which represents the onset of dementia before65 years old, is only about 1/10 to 1/100 proportion of late onset dementia. The YOD is different from late onset dementia in the proportion of degenerative subtype (e.g. the FTLD is more frequent than AD). Besides, frequent atypical presentation of clinical syndrome in the YOD which characterize the different variant of AD made the early accurate diagnosis of AD is more difficult. Currently, there is no available data to describe the proportion of subtype in YOD in Taiwan. In AD dementia, two important biomarkers are amylod plaque made by ß-amyloid protein and neurofibrillary tangle made by phosphorylation tau protein. In the past, they only can be seen under the microscope findings at autopsy study. Recently, the new amyloid tracer and tau tracer had been developed and could evaluate the deposition of amyloid and tau protein in human brain. These progresses had substantially improved the accurate diagnosis of degenerative dementia. A noval tau tracer [ 18F]PM-PBB3, which had substantially improved the off-target binding and more clear background in human brain than previous tau tracer. In current project, investigator will aim to consecutive collect 50 YOD due to the neurodegeneration in 3 years using the NIA-AA research framework system(ATN system) to achieve accurate diagnosis of the dementia subtype by the detail clinical neurology study, neuropsychological examination, amyloid positron emission tomography (PET) and tau PET study. In the first year, investigator will perform feasibility study to explore the topographical tau distribution in different subtype of YOD. In the next 2 years, investigator will perform a large scale study in a group of YOD to understand the amyloid and tau deposition and their association with clinical parameters. From current project, investigator could understand the tau deposition in different YOD subtype. Investigator also could understand the correlation between clinical phenotype and molecular pathology. Investigator will use a mathematic model to construct the model of diffusion kurtosis imaging from brain magnetic resonance imaging (MRI) and relate the white matter integrity with amyloid and tau PET imaging.