Dementia Clinical Trials

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. Read Less

Our study objective is to widely implement and evaluate a user-centered, scalable, electronic health record (EHR)-linked strategy for the routine detection of cognitive decline among diverse primary care settings. This strategy, called ToolboxDetect, will provide an efficient and sensitive cognitive screen that can be easily implemented in everyday clinical settings, and is responsive to patient, family, and caregiver concerns for potential symptoms of cognitive decline (CD) and cognitive impairment (CI). Read Less

Cognitive decline in dementia is considered irreversible, however episodes of paradoxical lucidity (PL) in severe dementia suggest other mechanisms may be in play. Beyond anecdotal reports of transient PL events occurring in patients predominantly in late-stage dementia and typically lasting anywhere from a few minutes to several hours, little is known about PL. The study team proposes to develop and conduct a mixed methods prospective study of PL during end stage advanced dementia, creating a definition and measurement scale for PL in advanced dementia, and identifying the potential electro cortical biomarkers of PL in advanced dementia. This study will be divided in two phases: Phase I and Phase II. During Phase I, the study team will collect sufficient and necessary data through an online survey and focus groups as well as assess the safety and feasibility of using symptom diaries (also known as daily trackers or journals) and real-time video EEG monitoring (vEEG). After preliminary review of the study procedures, the PI will decide whether to move onto the Phase II. The second phase will aim to expand the study population and refine study methods as well as create a definition and measurement scale for PL in advances dementia. Read Less

The research team will train primary care practitioners from Kansas City clinics to enhance skills in cultural competence, dementia detection, treatment and referral to a Health Navigator among Latinos 65 and older with dementia. The Health Navigator will provide patient/caregiver dyads referred by Alianza Latina providers with care management, psychosocial support and links to relevant community resources. Outcomes include feasibility and acceptability of 1) PCP training and 2) patient and caregiver dementia care. Read Less

The goal of this prospective cohort study is to assess potential differences in sleep biomarkers in older adult patients undergoing major orthopedic surgery. The main questions it aims to answer are: To define sleep/circadian biomarkers of delirium (sleep duration, regularity, stability and timing of rhythm) in a prospective observational study. To determine if plasma Alzheimer's disease (AD) pathology/inflammatory burden interacts with or moderates the relationship between a sleep/circadian biomarker and post-operative delirium (POD) risk. To determine whether sleep/circadian regulation interacts with the genetic risk of AD to influence POD/cognitive decline. Participants will be asked to: Donate several blood samples both intraoperatively and postoperatively Complete baseline and postoperative neurocognitive assessments Wear an actigraphy data collection watch for the two weeks prior to their surgery Read Less

Efficient and user-friendly paradigms to detect cognitive impairment, including dementia are needed in primary care. The TabCAT Brain Health Assessment accurately detects cognitive impairment via an appealing tablet interface with automated scoring and EMR integration. This study will evaluate the effectiveness of the paradigm on detection rates and other brain health outcomes via a pragmatic cluster randomized trial in 26 Kaiser Southern California primary care clinics. Read Less

The overall objective of this study is to compare knowledge, decisional conflict, preferences, and caregiver burden over time caregivers of Alzheimer's Disease and Related Dementias (ADRD) patients by comparing the effectiveness of a video decision aid intervention and enhanced usual care. Read Less

The goal of this clinical trial is to develop a dementia care intervention for persons receiving home-based primary care (HBPC) and living with dementia (PLWD) and their caregivers, and test the feasibility of implementing the intervention in HBPC practices to ultimately improve outcomes of PLWD and their caregivers. The main aims are to: Develop and refine HBPC Dementia Care Quality at Home Establish feasibility (primary outcome), acceptability, and fidelity of HBPC Dementia Care Quality at Home through an open-pilot trial involving two HBPC practices. Trained clinicians and staff at two HBPC practices will implement the intervention Relevant stakeholders (caregivers of PLWD, and HBPC clinicians and staff) will participate in qualitative focus groups to provide feedback on the intervention. Read Less

Dementia, a chronic disease of aging, is characterized by progressive cognitive decline that interferes with independent functioning. The medical, psychological, social and functional sequelae of dementia cause great stress to patients, their caregivers, and their family. The investigator proposes to examine effectivness of a home-based care coordination and management device, called Care4AD to help caregivers effectively coordinate, manage, and improve dementia care. Read Less

The purpose of this study is to develop a prototype of a home-based, dyadic tangible toolkit comprised of simple tools to help people living with dementia (PLWD) and their care partners manage stress at home. A human-centered design approach will be used to develop and user-test a prototype of a dyadic, tangible stress-management toolkit with and for PLWD and their care partners; and to explore the feasibility of collecting several stress-related outcomes. A total of 4 focus groups (n=3-4 dyads/group) will be convened to explore the experiences, perceptions, preferences, and recommendations of dementia-caring dyads regarding stress, stress management, and key components and features of a stress management toolkit. Eligible tools for the toolkit include low burden, high safety tools such as weighted blankets, robotic pets and baby dolls, guided journals, aromatherapy and bright light therapy devices, and massage and acupressure tools. Ten dyads who were not involved in prototype development will then use the toolkit for 2 weeks. Feedback on usability, feasibility, and acceptability will be collected through questionnaires (end of weeks 1 and 2) and 3 focus groups (3-4 dyads/group at end of week 2). We will collect stress-related, participant-reported outcomes (e.g., neuropsychiatric symptoms of dementia, caregiver stress, dyadic relationship strain), and saliva biospecimens from participants with dementia and their care partners at baseline and end of week 2, to explore their utility as endpoints in a future toolkit intervention that uses a single-arm, pre-post study design. Results will yield valuable data to support development and preliminary testing of a stress management toolkit intervention in a future pilot study. This study involves human subjects and is expected to yield no more than minimal risk. Tools eligible for the toolkit must have demonstrated high degrees of safety in prior research. Major risks for participation include the potential for negative emotional responses to focus group discussions and surveys pertaining to stress, excess time burden to participate in the study, and breach of confidentiality. It is not anticipated, but there is a potential for physical discomfort if tools are not used as directed, which is why the toolkits will include a user guide outlining safety information, which a research team member will review with each participant prior to use. Read Less

The research objective of this study is to examine the efficacy of HD-tDCS to the preSMA/DACC region and its influence on verbal episodic memory in patients with MCI or dementia after 10 sessions of HD-tDCS. There will be three treatment arms: two active HD-tDCS (1 mA or 2 mA) and a sham group. A verbal episodic memory task will be completed at baseline, immediately following the last HD-tDCS session, and a 2-month follow-up. Read Less

This is a first in human study that will assess the safety and diagnostic performance of [18F]RP-115 (fluorine-18 labeled RP115), a positron emission tomography (PET) agent. This agent has the potential to identify the early changes that occur in the brains of patients with Alzheimer's disease (AD) and frontotemporal dementia (FTD). Read Less