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Dementia, Vascular clinical trials

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NCT ID: NCT05860127 Active, not recruiting - Dementia Clinical Trials

Cognitive Stimulation Therapy for Dementia: A Two-Armed Pragmatic Trial

Start date: April 10, 2023
Phase: N/A
Study type: Interventional

Cognitive Stimulation Therapy (CST) is an evidence-based non-pharmacological group therapy shown to benefit people with mild to moderate dementia. Despite increasing availability of CST worldwide, access remains limited in the United States. This pilot pragmatic trial will embed CST referral into the standard care protocol of health care settings that serve people living with dementia in the state of Connecticut, and evaluate online delivery of CST known as virtual CST (V-CST), and assess the acceptability of V-CST to people living with dementia. The study design is a two-armed randomized embedded pragmatic clinical trial (ePCT). The trial aims to determine if cognitive decline is experienced less commonly among V-CST participants than control group members based on three widely used measures of cognition, the Montreal Cognitive Assessment (MoCA), St. Louis University Memory Screen (SLUMS), and Mini Mental State Exam (MMSE). The study population will be persons with mild to moderate dementia identified by clinicians in standard care. From this population, subject participants will be randomized to intervention and control groups. Patients randomly assigned to the intervention group will be referred by their clinical providers to participate in V-CST, and those who accept the referral will participate in the intervention.

NCT ID: NCT05704309 Enrolling by invitation - Diabetes Clinical Trials

The Diabetes Prevention Program Outcomes Study AD/ADRD Project

DPPOS-4
Start date: November 7, 2022
Phase:
Study type: Observational

The DPPOS AD/ADRD project will address the overarching question: What are the determinants and the nature of cognitive impairment among persons with pre-diabetes (PreD) and type 2 diabetes (T2D), who are a high-risk group for cognitive impairment and represent a large fraction of the United States (US) population? This U19 proposal addresses the National Alzheimer's Project Act goal to "prevent, halt, or reverse AD" in the high-risk group of persons with pre-diabetes and type 2 diabetes, who represent over half of the population aged 60 years and older in the US.

NCT ID: NCT05669365 Active, not recruiting - Dementia Clinical Trials

The Care Ecosystem Consortium Effectiveness Study

Start date: January 17, 2023
Phase: N/A
Study type: Interventional

The Care Ecosystem is an accessible, remotely delivered team-based dementia care model, designed to add value for patients, providers and payers in complex organizational and reimbursement structures. Care is delivered via the phone and web by unlicensed Care Team Navigators, who are trained and supervised by a team of dementia specialists with nursing, social work, and pharmacy expertise. The evidence base to date suggests that the Care Ecosystem improves outcomes important to people with dementia, caregivers, and payers when delivered in a controlled research environment, including reduced emergency department visits, higher quality of life for patients, lower caregiver depression, and reduced potentially inappropriate medication use (Possin et al., 2019; Liu et al., 2022). The investigators propose a rapid pragmatic trial in 6 health systems currently offering the Care Ecosystem program in geographically and culturally diverse populations. The investigators will leverage technology, delivering care via the phone and web and using electronic health records to monitor quality improvements and evaluate outcomes while maximizing external validity. The investigators will evaluate the effectiveness of the Care Ecosystem on outcomes important to patients, caregivers, healthcare providers, and health systems during the pandemic. By evaluating the real-world effectiveness in diverse health systems that are already providing this model of care, this project will bridge the science-practice gap in dementia care during an unprecedented time of heightened strain on family caregivers, healthcare providers and health systems.

NCT ID: NCT05586750 Active, not recruiting - Aging Clinical Trials

Statins in Reducing Events in the Elderly Mind (STAREE-Mind) Imaging Substudy

STAREE-Mind
Start date: September 19, 2019
Phase: Phase 4
Study type: Interventional

The STAREE-Mind imaging sub-study will examine the effect of statin treatment over a 4-year period, compared with placebo, on markers of brain health.

NCT ID: NCT05565976 Recruiting - Metabolic Syndrome Clinical Trials

Dapagliflozin Effect in Cognitive Impairment in Stroke Trial

DECIST
Start date: August 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Background: Dementia is an international public health problem, affecting approximately 50,000,000 people worldwide in 2018 and will triple by 2050; furthermore, reaching an approximate cost of 4 billion dollars. Given its high worldwide prevalence and probable underdiagnosis, the international guidelines for the assessment of dementia syndromes recommend the assessment of cognitive impairment in patients over 55 years of age as part of clinical practice in patients who presented an ischemic cerebrovascular event. Several risk factors associated with cognitive impairment in cerebrovascular disease are identified in the literature: 1) demographic factors (e.g., age over 65 years and female sex); 2) risk factors present prior to the ischemic stroke (e.g., cognitive impairment, physical impairment); 3) factors utilized to assess the severity of an ischemic stroke (e.g., supratentorial location, ischemic stroke in the dominant hemisphere, recurrence of ischemic strokes); 4) post-ischemic stroke factors (e.g., delirium and seizures); and 5) factors associated with neuroimaging findings (e.g., cerebral small vessel disease, cortical atrophy, and medial temporal lobe atrophy). This is a randomized controlled trial in individuals with an acute ischemic stroke without dementia that will be treated with 10mg dapagliflozin PO q24h for 12 months and standard treatment against only standard treatment (i.e., statins, platelet antiaggregant, and hypoglycemic medications) when appropriate. The outcome measure evaluated will be global cognitive function. Cardiovascular risk factors will be associated with cognitive decline.

NCT ID: NCT05524181 Active, not recruiting - Alzheimer Disease Clinical Trials

Telehealth-enabled Integrated Palliative Care for People With Dementia

IBC
Start date: June 29, 2022
Phase: N/A
Study type: Interventional

In prior work, this team developed a telehealth primary care model (TIPC), designed in close partnership with patients and clinicians to address a widespread increase in telehealth use during the COVID-19 pandemic. This research team will test the TIPC intervention to assess support for patients among a population of persons with dementia (PwD). Participants will be enrolled in the study for a 12 month period. This study's aims are 1) to explore the impact of the TIPC intervention on patient-important outcomes, engagement with community-based support provided through insurers, advanced care planning (primarily identification of health-care proxy), and patterns of hospice and healthcare utilization in the target population and 2) to evaluate patient, caregiver, and clinical team perspectives of feasibility and acceptability of a TIPC model, and apply findings from this work to the development of a larger randomized control trial designed to assess long-term efficacy of TIPC intervention.

NCT ID: NCT05516342 Completed - Alzheimer Disease Clinical Trials

LEAD IT! An App to Enable Persons With Early Stage Dementia to Lead Group Activities for Their Peers

Start date: November 10, 2020
Phase: N/A
Study type: Interventional

The proposed Phase 2 project will involve the further development and evaluation of LEAD IT!, which is a tablet-based app designed to enable persons with dementia to lead activities for their peers (i.e., other persons with dementia). The study will examine the clinical outcomes of long-term use of the app by both Resident Leaders (RLs) and Resident Players (RPs). The Specific Aims of the proposed Phase 2 project are to: 1. Develop improved Beta 1 and Beta 2 Versions of LEAD IT! with sufficient content to facilitate six activities twice per week for 4.5 months. 2. Examine the extent to which RLs are able to serve as leaders while using LEAD IT! 3. Examine the effects of resident-led LEAD IT! programming on RPs. 4. Examine PWD and staff satisfaction with LEAD IT!

NCT ID: NCT05516147 Active, not recruiting - Alzheimer Disease Clinical Trials

SAFE at Home: A Service to Provide Social Engagement to Community-Dwelling Persons With Dementia

Start date: January 19, 2024
Phase: N/A
Study type: Interventional

The proposed Phase 1 study will involve initial development and evaluation of a new service called Social Activities For Engagement at Home or SAFE at Home (SaH). SaH will enable PWD to participate in videoconference-based group activities with their peers-i.e., other PWD. SaH sessions will be facilitated by highly trained "Engagement Professionals," who will be SaH staff members that have a background in recreation therapy, activity coordination, or a similar field. The proposed study has three Specific Aims: Aim 1. Develop an Alpha version of the SaH app, including app infrastructure and preliminary activity content for live group sessions, as well as staff training and coaching modules. Aim 2. Examine the app's acceptability/feasibility (by assessing attendance, session length, and engagement/affect). Aim 3. Examine satisfaction with the app by directly eliciting feedback from PWD and life enrichment staff.

NCT ID: NCT05516134 Not yet recruiting - Alzheimer Disease Clinical Trials

All About Me: An Intervention to Ease the Transition to Long Term Care

AAM
Start date: March 28, 2024
Phase: N/A
Study type: Interventional

This Phase I study will involve initial development and evaluation of an innovative cross-platform software app called All About Me (AAM), which will consist of Serious Digital Health Games (SDHGs) for PWD. The AAM app will assist staff in providing person-centered care and enable residents to improve relationships with one another and with staff, thereby promoting a sense of community. This Phase I study has three Specific Aims: (1) Develop an Alpha version of the AAM App, (2) Examine acceptability of and satisfaction with the AAM App, and (3) Examine the impact of the Resident Game Bundle / Survey Says Game on engagement/affect.

NCT ID: NCT05515679 Completed - Alzheimer Disease Clinical Trials

The BRAIN App: Building Relationships Using Artificial Intelligence and Nostalgia

BRAIN
Start date: July 13, 2022
Phase: N/A
Study type: Interventional

This study will involve testing of an Alpha version of an app called "Building Relationships using Artificial Intelligence and Nostalgia" or BRAIN. The BRAIN App will be the first -ever artificial intelligence infused CST app for PWD. The app has two main goals: (1) to foster positive relationships between the care triad, and (2) to promote QoL while reducing responsive behaviors in PWD. Testing will examine the app's impact on engagement/affect for both PWD and professional Care Partners.