Treatment Trials

18 Clinical Trials for Various Conditions

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RECRUITING
A Music-Based Mobile App for People Living With Alzheimer's Disease and Related Dementias (ADRD)
Description

The purpose of this pilot is to develop a mobile application that detects physiological measures of individuals with Alzheimer's disease and related dementias and triggers auto-play of personalized songs in a wearable device. The investigators will test the feasibility and acceptability of the app. This app may be an important tool to include in daily caregiving in a home setting by extending established benefits of music therapy for people with Alzheimer's disease and related dementias.

RECRUITING
Investigation of Inflammation in Alzheimer's Disease and Related Dementias (ADRD) Using [11C]-CS1P1
Description

This study involves a brain positron emission tomography (PET) scan with a new, investigational radioactive tracer called \[11C\]-CS1P1 to identify inflammation in the brain by testing with healthy older adults and with cognitively impaired older adults.

RECRUITING
Home-based Transcranial Direct Current Stimulation (tDCS) for Behavioral Symptoms in Alzheimer's Disease and Related Dementias (ADRD)
Description

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.

ACTIVE_NOT_RECRUITING
Collaborative Care Coordination Program for Alzheimer's Disease and Related Dementias
Description

This is a randomized, pragmatic clinical trial to evaluate the effectiveness of a collaborative care-coordination program embedded in a health plan for people living with Alzheimer's disease and related dementias (ADRD) and their care partners versus usual care. The study population will include community-dwelling Medicare Advantage members living with ADRD and their care partners. Outcomes will be healthcare utilization outcomes of individuals with ADRD and include emergency department visits, outpatient visits, avoidable emergency department visits, and admission to long-term care facilities.

RECRUITING
Digital Detection of Dementia (D Cubed) Studies: D3
Description

The specific aim of the pragmatic trial is to evaluate the practical utility and effect of the PDM, the QDRS, and the combined approach (PDM + QDRS) in improving the annual rate of new documented ADRD diagnosis in primary care practices.

COMPLETED
Digital Detection of Dementia (D Cubed) Studies: D2
Description

The specific aim of the pragmatic trial is to evaluate the practical utility and effect of the PDM, the QDRS, and the combined approach (PDM + QDRS) in improving the annual rate of new documented ADRD diagnosis in primary care practices.

ENROLLING_BY_INVITATION
The DIAGNOSE CTE Research Project-II
Description

Each year, millions of people are exposed to repetitive head impacts (RHI) through contact sports. RHI can result in concussions and asymptomatic non-concussions to confer risk for Alzheimer's disease (AD) and related dementias (ADRD) including chronic traumatic encephalopathy (CTE). Presently, a diagnosis of CTE can only be rendered at autopsy and it has been neuropathological diagnosed in several hundreds of American football players particularly those who played at elite levels (college and professional). The ability to make an accurate diagnosis of CTE is needed to facilitate research on risk factors, mechanisms, prevention, and treatment. In 2015, the investigators were awarded a NINDS funded 7-year U01 known as the DIAGNOSE CTE Research Project (NCT02798185) designed to develop biomarkers, characterize the clinical presentation, and examine genetic and RHI risk factors for CTE. This current 5-year NIH funded multicenter study DIAGNOSE CTE Research Project-II will build on and extend those findings.

RECRUITING
OTC Hearing Aid and MCI
Description

The goal of this study is to better understand if, in patients with mild to moderate hearing loss who are also experiencing mild cognitive impairment (MCI) or Alzheimer's disease and related dementias (ADRD), Over-the-Counter (OTC) hearing aids: 1. improve communication 2. Whether the magnitude of benefit depends on the patient's level of cognitive disability, 3. Whether alternative remediation (such as targeted communication strategies) offer similar benefits. Participants and a communication partner will be randomized into an OTC first or Communication Strategies first arm, where participants will receive communication strategy information customized for those with cognitive impairment.

COMPLETED
Equality in Caregiving: Facilitating Caregiver Mastery Among LGBT Caregivers of PLWD
Description

The goal of this study is to adapt existing Savvy Caregiving Program (SCP) for lesbian, gay, bisexual, transgender (LGBT) caregivers of person living with dementia (PLWD). After watching the SCP Remote Learning videos, participants will attend a focus group to discuss how the program could be changed to meet the specific needs of LGBT caregivers of PLWD.

RECRUITING
Door-Through-Door Companion Rideshare Technology for Individuals with Alzheimer's Disease and Related Dementias (AD/ADRD)
Description

The goal of this pilot randomized controlled trial is to assess the impact of D2D rideshare services with a trained companion driver on the rate of medical appointments for older adults and individuals with AD/ADRD. Participants will be assigned either door-through-door (D2D) rideshare or curb-to-curb (C2C) rideshare services. he main question it aims to answer is: Do D2D rideshare services reduce missed medical appointment rates compared to C2C rideshare services?

RECRUITING
Development of Measures to Screen for Financial Hardship in Alzheimer's Disease and Dementia
Description

Alzheimer's Disease and related dementias (AD/ADRD) are common and debilitating conditions. Financial hardship, a multidimensional construct of financial strain, financial stress and asset depletion, is common in AD/ADRD due to exorbitant out-of-pocket spending such as for long-term care, lower work productivity and income for their caregivers that can last for decades after disease onset, and difficulty deciding between nursing home care or home-based care while negotiating insurance coverage. People from historically marginalized groups can experience a double disparity with fewer financial resources to manage AD/ADRD and a greater risk of AD/ADRD. Screening for financial hardship in AD/ADRD is key for addressing the needs of patients and caregivers but critical barriers include a lack of suitable screening measures. Current measures are very general and meant for people without chronic medical conditions or are specific to other diseases. To fill this gap, this study will create a suite of measures that can screen for financial hardship in people with AD/ADRD and their families and caregivers. The measures will include a set to assess caregiver burden; a set to assess patient hardship as reported by the caregiver for patients who cannot report for themselves; and a set of patient-reported measures for patients that are able to report for themselves. To create these financial hardship screening measures, the project will conduct the following aims. Aim 1- Develop financial hardship screening measures for Alzheimer's Disease and related dementias: Using interviews with both caregivers and people with AD/ADRD, key indicators of financial hardship that are unique to AD/ADRD and the point in the lifespan in which it occurs will be identified. The ways that social and caregiver network size affect financial hardship will also be explored. Using the interviews and previous measures, preliminary measures will be created and will be reviewed by experts and a patient and caregiver advisory board. Aim 2- Create item response theory-based screening measures for financial hardship measures in Alzheimer's Disease and related dementias: Large samples of people with AD/ADRD (n=1000) and caregivers (n=1000) will be surveyed and item response theory will be used to evaluate and revise the measures and create scoring algorithms. A sample of additional caregivers matched to primary caregivers (n=400) will also be recruited to evaluate interrater reliability of the measures. Aim 3- Evaluate the financial hardship measures across patient and caregiver populations: Using the sample from Aim 2 and item response theory, we will evaluate the financial hardship screening measures across the following groups to ensure they are unbiased and reflect true differences: race/ethnicity; patient comorbidities; stage of AD/ADRD; caregiver relationship; social network size; number of caregivers; financial support provided; and caregiver's own health status (disability, comorbidities). The resulting measures will improve identification of financial hardship in AD/ADRD.

RECRUITING
Reducing Suicide Risk Among Aging Caregivers of Persons With AD/ADRD
Description

This project aims to adapt, implement, and evaluate a Dialectical Behavior Therapy skills training group intervention for aging adult family caregivers of person with Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD) to reduce suicidality. By adapting this modality, the investigators will provide a scalable intervention tailored for this high-risk population, maximizing the public health impact and improving suicide prevention.

COMPLETED
Enhanced CBTi for Older Adult Sleep and Cognition
Description

This randomized clinical trial on 60+ aged and independent-living healthy individuals with symptoms of insomnia will attempt to improve sleep and health outcomes related to sleep with enhancement of a clinical intervention, Cognitive Behavioral Therapy for Insomnia (CBTi).

ACTIVE_NOT_RECRUITING
Supporting Our Caregivers In ADRD Learning (SOCIAL)
Description

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.

COMPLETED
MASC: Reducing Stress for Caregivers
Description

Building on limitations of prior research, the investigators proposed to develop 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.

RECRUITING
Natives Engaged in Alzheimers Research - 'Ike Kupuna
Description

This study will conduct a group randomized trial to test the effects of a hula-based intervention in improving vascular risk factors for ADRD and cognitive complaints and function over 12 months.

RECRUITING
BCT Intervention For Walking Habit Among Caregivers of People With AD/ADRD
Description

This 12-week trial will test the efficacy of a multi-component, personalized text-message delivered behavior change technique (BCT) intervention to encourage habitual physical activity (defined as regular walking of 1,000 or more steps during a one-hour period on 7 consecutive days according to a personalized walking plan) among care providers of persons with AD/ADRD via the key mechanism of behavior change (MoBC) of automaticity. The main question it aims to answer whether a multi-component, personalized BCT intervention to increase a walking habit of 1,000 steps/day will lead to successful development of habitual walking among 60 percent of caregivers enrolled.

RECRUITING
A BCT Intervention for an Hourly Activity Habit Among Caregivers for Persons With AD/ADRD
Description

This 12-week trial will test the efficacy of a personalized, multi-component, personalized text-message delivered behavior change technique (BCT) intervention to encourage habitual hourly physical activity among care providers of persons with Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD) via the key mechanism of behavior change (MoBC) of automaticity. The main question it aims to answer is whether a multi-component, personalized BCT intervention to increase habitual walking of \>250 steps/hour will lead to successful development of habitual hourly walking among 50% of caregivers.