Treatment Trials

11 Clinical Trials for Various Conditions

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RECRUITING
Sirtuin-NAD Activator in Alzheimer's Disease
Description

The primary objectives are to: 1. To determine whether MIB-626, after its daily oral administration, penetrates the blood-brain barrier in humans by measuring the cerebrospinal fluid (CSF) concentrations of MIB-626 and its key metabolites, nicotinamide (NAM), NR, 2-PY, and MeNAM at baseline and on day 90 at steady state. 2. To evaluate whether oral MIB-626 administration engages the sirtuin-NAD pathway by determining the abundance of NAD (a SIRT1 substrate) in the brain using ultra-high field 7T magnetic resonance spectroscopy and in peripheral blood mononuclear cells using a validated LC-MS/MS assay. 3. To determine whether MIB-626 alters the circulating biomarkers of aging that the geroscience experts have recommended (HbA1C, IGF1, T3, IL6, TNF, and urinary F2-isoprostane).

UNKNOWN
Beyond Listening: A Music-based Intervention
Description

Study will be conducted to determine if caregivers who use music at home will feel less burden and whether the person they are caring for will demonstrate decreased symptoms of dementia. Caregivers will participate in a series of psycho-educational trainings for six weeks. During this time, caregivers will learn how to use singing, music listening and music with movement with their family member. Caregivers should feel less stressed and a decreased sense of burden. The care recipient should appear happier with less occurrences of depression or restlessness.

COMPLETED
Improvisational Movement for People With Memory Loss and Their Caregivers
Description

Dementia is a progressive decline in cognition that impairs a person's ability to perform activities of daily living. Changes in mood, gait, and balance are prominent secondary symptoms of Alzheimer's dementia that can dramatically decrease quality of life for the person with dementia and increase caregiver burden. The overall aim of this study is to determine the independent and combined effects of dance movement and social engagement on quality of life in people with early-stage dementia, and test the neural mechanisms of these effects.

COMPLETED
Vietnamese Caregiver Intervention Study
Description

The purpose of this study is to develop and implement a culturally-appropriate intervention to reduce stress in Vietnamese dementia caregivers. A pilot intervention will be done to test the feasibility and acceptability of the intervention in a community setting. This will be done by randomly assigning a family triad (primary caregiver, secondary caregiver, and their care recipient) into an active intervention or a control condition and monitoring findings at baseline, post-intervention, and at three months.The intervention will consist of multiple components -enhanced psycho-education that includes discussion of Alzheimer's Disease (AD) and cultural impacts on beliefs about dementia and caregiving, management of problem behaviors, facilitation of support seeking, and mindful Tai Chi. A secondary caregiver who the primary caregiver identifies as providing him/her with the most support will be invited to join all components, but the intervention will be flexible depending on caregivers' needs/preferences. The care recipient is not required to join the sessions but will be able to if he/she or the family wishes. During the intervention, community partners will provide respite care for the care recipient.

RECRUITING
Improving PCP Advance Care Planning for People With ADRD
Description

This study will test the Dementia Advance Care Planning (AD ACP) Toolkit intervention to usual care in facilitating goals of care (GOC) discussions between People Living with Dementia (PLwD) and primary care team members over an 18-month period. The primary outcome is to assess the frequency and quality of GOC discussions with PLwD. Secondary outcomes include the identification of preferred surrogates, assessment of decisional capacity, and the completion of portable ACP orders. This randomized clinical trial aims to determine if the AD ACP Toolkit can enhance ACP practices and improve care planning outcomes for PLwD compared to the standard care approach.

RECRUITING
Chronic Treatment of Alzheimer's Disease by Gamma Light and Sound Therapy
Description

Alzheimer's disease (AD) is characterized by significant memory loss, toxic protein deposits amyloid and tau) in the brain, and changes in the gamma frequency band on EEG. The investigator's lab found that boosting gamma waves in AD mouse models using light and sound stimulation at 40Hz not only reduced amyloid and tau in the brain, but also improved memory. The investigators developed a light and sound device for humans that stimulates the brain at 40Hz that can be used safely at home. For the present study, 60 participants with mild Alzheimer's disease will be enrolled and will use this light and sound device at-home daily for 6-months. Investigators will measure changes in brain waves with EEG, blood biomarkers, the microbiome via fecal samples, functional and structural MRI scans, memory and cognitive testing, and questionnaires at 3 in-person visits throughout the study. After the 6-month time point, participants will have the option of continuing in the study for one additional year and completing an 18-month study visit. This study will provide critical insight into extended therapy involving non-invasive 40Hz sensory stimulation as a possible therapeutic strategy for mild to moderate Alzheimer's disease.

RECRUITING
Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes
Description

Aim 1: Characterize shared decision-making and unmet patient-caregiver dyads needs for patients with diabetes and Alzheimer's Disease and related dementias (ADRD) while using a continuous glucose monitoring (CGM) device. Aim 2: Develop an interactive tool to enhance shared decision-making for diabetes management.

TERMINATED
Amyloid Prediction in Early Stage Alzheimer's Disease Through Speech Phenotyping - FUTURE Extension
Description

The primary objective of the study is to evaluate whether a set of algorithms analysing acoustic and linguistic patterns of speech, can predict change in Preclinical Alzheimer's Clinical Composite with semantic processing (PACC5) between baseline and +12 month follow up across all four Arms, as measured by the coefficient of individual agreement (CIA) between the change in PACC5 and the corresponding regression model, trained on baseline speech data to predict it. Secondary objectives include (1) evaluating whether similar algorithms can predict change in PACC5 between baseline and +12 month follow up in the cognitively normal (CN) and MCI populations separately; (2) evaluating whether similar algorithms trained to regress against PACC5 scores at baseline, still regress significantly against PACC5 scores at +12 month follow-up, as measured by the coefficient of individual agreement (CIA) between the PACC5 composite at +12 months and the regression model, trained on baseline speech data to predict PACC5 scores at baseline; (3) evaluating whether similar algorithms can classify converters vs non-converters in the cognitively normal Arms (Arm 3 + 4), and fast vs slow decliners in the MCI Arms (Arm 1 + 2), as measured by the Area Under the Curve (AUC) of the receiver operating characteristic curve, sensitivity, specificity and Cohen's kappa of the corresponding binary classifiers. Secondary objectives include the objectives above, but using time points of +24 months and +36 months; and finally to evaluate whether the model performance for the objectives and outcomes above improved if the model has access to speech data at 1 week, 1 month, and 3 month timepoints.

UNKNOWN
Amyloid Prediction in Early Stage Alzheimer's Disease Through Speech Phenotyping - PAST Extension
Description

The primary objective of the study is to evaluate whether a set of algorithms analysing acoustic and linguistic patterns of speech can detect amyloid-specific cognitive impairment in early stage Alzheimer's disease, based on archival spoken or written language samples, as measured by the area under the curve (AUC) of the receiver operating characteristic curve of the binary classifier distinguishing between amyloid positive and amyloid negative arms. Secondary objectives include (1) evaluating how many years before diagnosis of Mild Cognitive Impairment (MCI) such algorithms work, as measured on binary classifier performance of the classifiers trained to classify MCI vs cognitively normal (CN) arms using archival material from the following time bins before MCI diagnosis: 0-5 years, 5-10 years, 10-15 years, 15-20 years, 20-25 years; (2) evaluating at what age such algorithms can detect later amyloid positivity, as measured on binary classifier performance of the classifiers trained to classify amyloid positive vs amyloid negative arms using archival material from the following age bins: younger than 50, 50-55, 55-60, 65-70, 70-75 years old.

COMPLETED
Amyloid Prediction in Early Stage Alzheimer's Disease Through Speech Phenotyping
Description

The primary objective of the study is to evaluate whether a set of algorithms analysing acoustic and linguistic patterns of speech can detect amyloid-specific cognitive impairment in early stage Alzheimer's disease, as measured by the AUC of the receiver operating characteristic (ROC) curve of the binary classifier distinguishing between amyloid positive (Arms 1 and 3) and amyloid negative (Arms 2 and 4) Arms. Secondary objectives include (1) evaluating whether similar algorithms can detect amyloid-specific cognitive impairment in the cognitively normal (CN) and MCI Arms respectively, as measured on binary classifier performance; (2) whether they can detect MCI, as measured on binary classifier performance (AUC, sensitivity, specificity, Cohen's kappa), and the agreement between the PACC5 composite and the corresponding regression model predicting it in all Arms pooled (Wilcoxon signed-rank test, CIA); (3) evaluating variables that can impact performance of such algorithms of covariates from the speaker (age, gender, education level) and environment (measures of acoustic quality).

COMPLETED
Hypnosis for Sleep Quality in Caregivers of Individuals With Alzheimer's Disease
Description

The long-range goal is to identify an efficacious and practical intervention to improve sleep quality and duration for family caregivers of individuals with Alzheimer's disease and related dementias (ADRD). The main goal of this study is to determine feasibility of a self-administered hypnosis intervention with caregivers of individuals with ADRD by randomizing eligible participants into one of two study arms, self-administered hypnosis (treatment group) or sham white noise hypnosis (control group). The investigators are also examining the feasibility of accrual, outcome measures (diaries, actigraphy) and study design.