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Alzheimer Disease clinical trials

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NCT ID: NCT04271046 Completed - Alzheimer Disease Clinical Trials

STAR Caregivers - Virtual Training and Follow-up

STAR-C-VTF
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

This study evaluates the effectiveness of a caregiver outreach, training, and support program for caregivers of people with dementia who are using antipsychotic medication to manage agitation/aggression. The Investigators will conduct a randomized trial of the caregiver program compared to a control group to measure differences in caregiver burden and discontinuation of antipsychotic medication use. The results will help in expanding access to and delivery of empirically supported behavioral health services for caregivers and people with dementia.

NCT ID: NCT04268953 Completed - Alzheimer Disease Clinical Trials

Study to Compare the Pharmacokinetics of Daily Administration of Tricaprilin on Ketone Body Production

Start date: February 27, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase I, single center, open label, multiple dose, pharmacokinetic (PK) study recruiting healthy older subjects.

NCT ID: NCT04265378 Completed - Clinical trials for Mild Cognitive Impairment

Cognitive Training and Brain Stimulation in Prodromal Alzheimer's Disease

AD-Stim
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to investigate whether a tDCS-accompanied intensive cognitive training of working memory leads to performance improvement in individuals with prodromal Alzheimer's disease.

NCT ID: NCT04251182 Completed - Alzheimer Disease Clinical Trials

Clinical Study Evaluating Efficacy and Safety of T3D-959 in Mild-to-moderate AD Subjects

Start date: March 1, 2021
Phase: Phase 2
Study type: Interventional

A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study to Evaluate the Safety and Efficacy of Three Dose Strengths of T3D-959 in Subjects with Mild-to-Moderate Alzheimer's Disease.

NCT ID: NCT04247347 Completed - Alzheimer Disease Clinical Trials

Tailored Health Self-Management Interventions for Highly Distressed Caregivers: Family Members of Persons With Dementia

Start date: August 29, 2019
Phase: N/A
Study type: Interventional

How do different health self-management interventions (resourcefulness training or biofeedback training) compare to usual care (dementia education) in affecting the health risks, and physical and mental health, of family caregivers of people with dementia? And, how do those health outcomes compare with similar measures for family caregivers of people with bipolar disorder? This one-year supplement study will exam these two aims as part of a larger four-year parent grant (NCT03023332). Caregivers enrolled in the study will be randomized to one of the three self-management interventions, with two data collections time points pre- and post-intervention.

NCT ID: NCT04206670 Completed - Alzheimer Disease Clinical Trials

In-Home Technology for Caregivers of People With Dementia and Mild Cognitive Impairment

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

This study aims to develop and evaluate new in-home supportive technology that is designed to alleviate anxiety, burden, and loneliness in spousal and familial caregivers of individuals with Alzheimer's disease, other dementias, or mild cognitive impairment.

NCT ID: NCT04200911 Completed - Alzheimer Disease Clinical Trials

Cognition, Age, and RaPamycin Effectiveness - DownregulatIon of thE mTor Pathway

CARPE_DIEM
Start date: June 1, 2020
Phase: Early Phase 1
Study type: Interventional

Evaluation of central nervous system penetration of orally administered Rapamune (RAPA) in older adults with Mild Cognitive Impairment (MCI) or early Alzheimer's disease (AD) and investigate associated safety, tolerability, target engagement, cognition, and functional status as initial proof-of-concept study

NCT ID: NCT04191486 Completed - Clinical trials for Mild Cognitive Impairment

Efficacy and Safety of T-817MA in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD

Start date: December 24, 2019
Phase: Phase 2
Study type: Interventional

Primary objective is to evaluate the neuroprotective effect of T-817MA on Tau protein phosphorylated at threonine 181 (p-tau 181) in cerebrospinal fluid (CSF) compared with placebo in patients with a diagnosis of MCI due to AD or mild AD. Secondary objectives are: 1. To evaluate in patients on T-817MA and placebo: - cognitive function measured by the Clinical Dementia Rating Scale Sum of Boxes (CDR-sb) and working memory and attention domain as measured by the Cognitive Functional Composite (CFC). - AD-related biomarkers in CSF and plasma - imaging analysis using volumetric magnetic resonance imaging (vMRI) - alpha/theta ratio of the electroencephalogram (EEG) 2. To evaluate the safety of T-817MA by clinical laboratory tests and adverse events (AEs). 3. To evaluate the pharmacokinetics of T-817MA

NCT ID: NCT04179721 Completed - Clinical trials for Alzheimer's Disease and Related Dementias

Reducing Behavioral and Psychological Symptoms of Dementia: Hospital Caregivers (Aim 2)

Start date: October 22, 2019
Phase: N/A
Study type: Interventional

Persons with Alzheimer's Disease and Related Dementias (ADRD) account for 3.2 million hospital admissions per year and have over three times more hospitalizations than those without cognitive impairment, yet hospital caregivers (HCGs) are ill-prepared to manage patients with ADRD with less than 5% reporting mandatory dementia care training. Three-quarters of hospitalized persons with ADRD display Behavioral and Psychological Symptoms of Dementia (BPSD) associated with functional and cognitive decline, increased resource consumption, institutionalization, premature death, and caregiver burden. The overall objective is to test the preliminary efficacy of an innovative model of care, PES-4-BPSD, for reducing BPSD by empowering Patient Engagement Specialists (PES) to deliver dementia care for acutely-ill patients with ADRD. Traditionally, mental health assistants with training in crisis-prevention techniques provide care to psychiatric patients. On the intervention unit, these mental health assistants, as PES, purposefully engage patients with BPSD. In the pilot study, investigators found patients with cognitive impairment admitted to the PES unit were significantly less likely to require constant observation, chemical and physical restraints, suggesting improved management of BPSD. The central hypothesis is that PES-4-BPSD will improve the ability of PES to create an "enabling" milieu that addresses factors leading to BPSD and improves the experience of hospital caregivers. Guided by a social-ecological framework, PES-4-BPSD incorporates dementia education and training, environmental modifications-cohorting, increased staffing-PES, and staff support. The investigators' multidisciplinary research team is well-positioned to accomplish the following: Aim 1) Determine the preliminary efficacy of PES-4-BPSD for reducing BPSD during hospitalization (please refer to NCT# 04481568 for more details on this aim), and Aim 2) Evaluate whether dementia care training improves the perceived ability of PES staff (intervention) and nurse assistant staff (control) to care for hospitalized persons with ADRD. For Aim 1, investigators will conduct a non-randomized preliminary efficacy trial of the PES-4-BPSD intervention enrolling N=158 patients (79 control, 79 intervention). The primary outcome will be presence of BPSD during hospitalization using the Neuropsychiatric Inventory-Questionnaire (NPI-Q). In Aim 2, investigators will use survey methodology in a repeated measures design to evaluate within and between-group differences in attitudes, experience, and satisfaction toward managing patients with ADRD. Measures will be completed at baseline (T1), immediately following training (T2), and at the end of the intervention period (T3). This proposal will be the first to study an innovative model of care utilizing PES as specialized hospital caregivers for reducing BPSD in the hospital setting. The investigators' findings will lay the essential groundwork for a multi-site trial of PES-4-BPSD and inform the development of a program that can be easily implemented in other hospitals.

NCT ID: NCT04165213 Completed - Alzheimer Disease Clinical Trials

Care of Persons With Dementia in Their Environments (COPE) in Programs of All-Inclusive Care of the Elderly (PACE)

Start date: June 28, 2021
Phase: N/A
Study type: Interventional

The protocol is organized into three Phases - In Phase I an online training program will be developed in "Care of Persons with Dementia in their Environments" (COPE) -an evidence-based bio-behavioral dementia program -using state-of-the science simulation and best online learning practices. In addition an automated approach to fidelity monitoring using computational linguistics (automatic classification programs) will be developed. In Phase II, ten long term care community-based (PACE) organizations will be randomized into two groups; 5 PACE organizations will serve as the "control" site in which staff training will be provided via the traditional high intensity face-to-face training in the COPE program. 5 PACE organizations will serve as the comparison and staff will be trained using the online COPE training program. Phase II will evaluate the whether an online training program is the same or better in improving PACE staff competency and fidelity to COPE principles and protocols compared to a high intensity face-to-face traditional form of training. In Phase III the efficacy of the COPE program on PACE participant outcomes by type of COPE training will be evaluated. Each of the PACE organizations will enroll 5 persons with dementia and their caregivers in the study. This will yield 50 family dyads (25 dyads in traditional training sites and 25 dyads in online training sites). Dyads will be followed for 4 months. Non-inferiority analysis will be used to assess whether dyads will yield the same or better outcomes regardless of how PACE staff were trained.