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22 recruiting in IN
Recruiting

I-CARE Rural Pilot: Intervention for Rural-Dwelling Dementia Caregivers

Caregiver Burden ยท Alzheimer Disease

The purpose of this study is to assess feasibility and to estimate efficacy of our app "Brain CareNotes" for dementia caregivers who reside in a rural setting (as defined by RUCA codes 4 through 10). The Brain CareNotes app is designed to reduce informal caregiver burden of those caring for individuals with Alzheimer's disease and related dementias (ADRD) and behavioral and psychological symptoms of dementia (BPSD) of individuals with ADRD. The study will enroll up to 60 rural caregivers of community-dwelling individuals living with ADRD. Caregivers will be randomized to use the Brain CareNotes app or an attention control education-only app for six months, with usage reminders.

Bloomington, IN18+ yrsAll genders
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A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)

Cognitive Dysfunction ยท Lewy Body Disease ยท Synucleinopathies

The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.

Indianapolis, IN55โ€“85 yrsAll genders
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I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms

Caregiver Burden ยท Alzheimer Disease

This study is a randomized, controlled trial (RCT) to evaluate the effect of Brain CareNotes (a mobile health application) on the burden experienced by unpaid caregivers of patients with dementia and on the behavioral and psychological symptoms of dementia (BPSD) displayed by care recipients. Over 39 months, the trial will enroll 184 caregivers of community-dwelling patients diagnosed with Alzheimer's disease or a related dementia (ADRD). Caregivers will be randomized to use the Brain CareNotes app or an attention control education-only app for 12 months, with usage reminders.

Indianapolis, IN18+ yrsAll genders
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A Study of a Potential Disease Modifying Treatment in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation

Alzheimers Disease ยท Dementia ยท Alzheimers Disease, Familial

The purpose of this research study is to test the study drug, referred to as remternetug, to determine its effectiveness for the study treatment of asymptomatic (at risk) Alzheimer disease in individuals with AD-causing mutations. This study will also investigate the effects of remternetug on biomarkers (measures of the disease including brain scans, blood and spinal fluid tests), examine safety data to identify any potential benefits or risks, and examine how well participants can tolerate remternetug. Stage 1 will determine if treatment with the study drug prevents or reverses amyloid beta (Aฮฒ) accumulation compared with placebo in participants with dominantly inherited Alzheimer's disease (DIAD). Stage 2 will evaluate the effect of early anti-amyloid treatment on downstream biomarkers of AD in treated participants compared to external control groups.

Indianapolis, IN18+ yrsAll genders
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A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation

Alzheimers Disease ยท Dementia ยท Alzheimers Disease, Familial

The purpose is to evaluate the biomarker effect, safety, and tolerability of investigational study drugs in participants who are known to have an Alzheimer's disease (AD)-causing mutation. Stage 1 will determine if treatment with the study drug prevents or slows the rate of amyloid beta (Aฮฒ) pathological disease accumulation demonstrated by Aฮฒ positron emission tomography (PET) imaging. Stage 2 will evaluate the effect of early Aฮฒ plaque reduction/prevention on disease progression by assessing downstream non-Aฮฒ biomarkers of AD (e.g., CSF total tau, p-tau, NfL) compared to an external control group from the DIAN-OBS natural history study and the DIAN-TU-001 placebo-treated participants.

Indianapolis, IN18+ yrsAll genders
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Caring for Caregivers of Individuals With Alzheimer's Disease

Intervention Group ยท Treatment as Usual

What is this study about? This study is called the EMBRACE Study - A Virtual Community Empowerment Approach Integrating Tradition and Technology for Family Caregivers of Individuals with Alzheimer's Disease. It tests whether a home-based virtual exercise program can reduce depression and anxiety in family caregivers of people living with Alzheimer's disease and related dementias (ADRD). Why is this study needed? Caring for a loved one with ADRD is demanding and is strongly linked to depression and anxiety. Regular exercise is one of the most effective ways to reduce these symptoms - but caregivers often cannot leave home to exercise due to the needs of their loved one, transportation concerns, and safety issues. What does participation involve? Participants will be randomly assigned (like a coin flip) to one of two groups: * EMBRACE group: 24 weekly virtual group exercise sessions over 3 months (about 1 hour each), using an at-home elliptical device provided by the study. Months 4-6 include weekly check-in calls to support independent exercise. Educational sessions on habit-building and goal-setting are included. * Wait-list control group: Completes the same surveys and measurements; receives the program after data collection ends. Who can join? Adults (18+) who are the primary unpaid caregiver for someone with ADRD, can read and speak English, and are healthy enough to exercise. Participants do not need to leave home - everything is virtual. What is being measured? Exercise time (using a wearable device), symptoms of depression and anxiety, and whether the program is feasible and acceptable to participants. Where is the study based? Indiana University Indianapolis. The study is conducted entirely virtually and remotely.

Indianapolis, IN18โ€“99 yrsAll genders
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Alzheimer's Disease Genetics Study

Alzheimer Disease ยท Late Onset Alzheimer Disease ยท Dementia

The purpose of the Alzheimer's Disease Genetics Study is to identify the genes that are responsible for causing Alzheimer's Disease (AD). One of the ways in which the risk factor genes for late onset AD can be investigated is by identifying and collecting genetic material from families with multiple members diagnosed with AD or dementia.

Nationwide, IN18+ yrsAll genders
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Nicotinic Acid for the Treatment of Alzheimer's Disease

Alzheimer Disease

Increased dietary intake of niacin is correlated with reduced risk of Alzheimer's Disease and age-associated cognitive decline. The goal of this study is to collect data on the penetration of commercially available, FDA approved, extended-release niacin into the spinal fluid. One dose of 500 mg nicotinic acid will be used (in addition to placebo) to build a dose response curve for this compound in human cerebrospinal fluid. This objective will demonstrate target engagement of HCAR2 in the central nervous system, after oral treatment with niacin. The primary endpoints are to show increased nicotinic acid levels in blood and cerebrospinal fluid. A secondary endpoint is to collect safety and tolerability data of niacin in this particular population.

Indianapolis, IN60โ€“85 yrsAll genders
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Trial-Ready Cohort-Down Syndrome (TRC-DS)

Down Syndrome ยท Alzheimer Disease ยท Dementia

The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort (TRC), and up to 550 participants in total including co-enrolled in the Alzheimer Biomarkers Consortium - Down Syndrome (ABC-DS) study. Participants enrolled in the TRC-DS will undergo longitudinal cognitive and clinical assessment, genetic and biomarker testing, as well as imaging and biospecimen collection. Using these outcome measures, researchers will analyze the relationships between cognitive measures and biomarkers of Alzheimer's disease (AD) to identify endpoints for AD clinical trials in DS that best reflect disease progression. To learn more about the study and participating sites, visit our study website at: https://www.trcds.org/. TRC-DS is collaborating with the Alzheimer's Disease Biomarker Consortium-Down Syndrome (ABC-DS) to allow study participants to be concurrently enrolled in both ABC-DS and TRC-DS, referred to as "co-enrollment". ABC-DS is a longitudinal, observational research study that is overseen at University of Pittsburgh Coordinating Center. ABC-DS participants who express interest in potentially joining a clinical trial in the future and who meet TRC-DS eligibility criteria, may choose to co-enroll in TRC-DS at an ABC-DS Site. Co-enrolled participants will adhere to the ABC-DS protocol and schedule of activities, but agree to share their data with the TRC-DS team and to receive invitations for future participation in clinical trials. Fore more information on ABC-DS please visit https://www.nia.nih.gov/research/abc-ds or http://abcds.pitt.edu/.

Indianapolis, IN25โ€“55 yrsAll genders
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A Feasiblity Study of Green Activity Program for People Living With Memory Challenges

Mild Cognitive Impairment ยท Alzheimer Disease ยท Subjective Cognitive Decline (SCD)

The purpose of this study is to test the Green Activity Program that was designed with people living with memory challenges and their study partners to see if it can be done and if they enjoy the program. "Green activities" are nature activities that the person enjoys and can be done with other people or pets. For example, dog walking, hiking, outdoor yoga, and gardening are all green activities. The purpose of the program is to help people living with memory challenges participate in nature activities they enjoy. The goal of the program is to help people stay active and improve their health and well-being.

Bloomington, IN45+ yrsAll genders
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Longitudinal Early-onset Alzheimer's Disease Study Protocol

Early Onset Alzheimer Disease ยท Alzheimer Disease ยท Mild Cognitive Impairment

The Longitudinal Early-onset Alzheimer's Disease Study (LEADS) is a non-randomized, natural history, non-treatment study designed to look at disease progression in individuals with early onset cognitive impairment. Clinical, cognitive, imaging, biomarker, and genetic characteristics will be assessed across three cohorts: (1) early onset Alzheimer's Disease (EOAD) participants, (2) early onset non-Alzheimer's Disease (EOnonAD) participants, and (3) cognitively normal (CN) control participants.

Indianapolis, IN40โ€“64 yrsAll genders
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Lifestyle Interventions for the Treatment of Early Onset Alzheimer's Disease Study

Alzheimer Disease, Early Onset

The purpose of this study is to generate preliminary data on the benefit of computerized cognitive training and Tai Chi- Qi Gong training in participants with Early-Onset Alzheimer's Disease. It is hypothesized that participants in the experimental training condition will perform better on outcomes related to cognition, functioning, and mood at follow-up compared to participants assigned to the active control condition.

Indianapolis, IN40โ€“75 yrsAll genders
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Multi-modal Large Language Model-Empowered Talk Therapy for Older Adults With ADRD

Mild Cognitive Impairment ยท Dementia ยท BPSD

The purpose of this study is to test the usefulness and the effect of Smart Virtual Reminiscence (SVR) therapy intervention on the Behavioral and Psychological Symptoms of Dementia (BPSD) of patients with Alzheimer's Disease and Related Dementias (ADRD). SVR is designed to help older adults improve their psychological well-being and cognition. This research supports our long-term goal of designing and implementing intelligent interactive systems to improve the health of individuals with ADRD.

Indianapolis, IN65+ yrsAll genders
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