Clinical Research Directory

Eye Movement Parameters and Cognitive Functions in Older Adults

Dementia most commonly occurs in elderly individuals, but currently there is still a lack of objective measurement methods that can detect cognitive impairment in older adults at an early stage. Eye movement is considered a clinical indicator with potential for screening mild cognitive dysfunction, and eye movement signals can be extracted to objectively evaluate cognition. Eye tracking has been used mostly to evaluate patients with neurodegenerative diseases such as Parkinson's disease. However, less attention has been paid to the relationship between eye movement and cognitive function in elderly individuals, as well as the association between eye movement data and abnormal cognitive subdomains. This cross-sectional study will recruit 0204 elderly individuals over the age of 65, divided into three groups (healthy group/mild cognitive impairment group/dementia group) according to the purpose of this study. Participants who have not been diagnosed with neurological diseases (such as Parkinson's disease or stroke), or have mental illness or visual impairments will be excluded. This study hopes to provide empirical data on eye movement signals and cognitive function in healthy older individuals, as well as to serve as a preliminary study for future development of eye activity stimulation to improve cognitive function in older adults.

Effect of Virtual Reality-Based Music Therapy on Cognitive and Motor Skills in Subacute Stroke Patients

This clinical trial aims to investigate the effects of immersive virtual reality-based music therapy on cognitive and motor functions in individuals aged 50 to 75 years with subacute stroke (between 2 weeks and 6 months post-stroke). Participants will be randomly assigned to either a control group receiving conventional physiotherapy or an experimental group receiving conventional physiotherapy plus virtual reality-based music therapy. The study will assess cognitive performance, upper extremity motor skills, stroke impact, balance, and spatial neglect before and after a 6-week intervention. All participants will be treated at Istanbul Aydın University VM Medical Park Hospital. The study has been approved by the ethics committee, and written informed consent will be obtained from all participants.

A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)

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.

COMPuter-assisted Self-training to Improve EXecutive Function

This project explores the effects of specialized computer-based cognitive rehabilitation (CBCR) targeting executive functions in three groups of patients: Stroke, Cardiac Arrest and Parkinson's Disease. The effect of specialized CBCR is compared to generally cognitively stimulating activities on a computer

Determination of the Effect of Puzzle Use in Elderly Patients

The aim of this study is to determine the effects of the use of a simple, reliable and cost-effective puzzle on post-operative cognitive function changes, postoperative recovery, and quality of life using questionnaires and face-to-face interview techniques.

Sleep Architecture, Cognitive Function, and Quality of Life During Early Recovery From Substance Use Disorder

This prospective cohort study investigates how sleep disturbances affect cognitive recovery and quality of life during early recovery from substance use disorder (SUD). Chronic substance use frequently alters normal sleep architecture, which may impair attention, memory, and everyday functioning. The primary aim is to characterize baseline sleep patterns in adults with SUD compared to healthy control participants and determine whether baseline sleep disruptions predict cognitive and functional recovery over three months of monitored abstinence. The study includes two groups of participants aged 18 to 45 years: adults diagnosed with a primary substance use disorder undergoing treatment and monitored abstinence, and a comparison group of healthy volunteers matched for age, sex, education, work schedule, and caffeine or nicotine use. At the beginning of the study, all participants complete: * Structured diagnostic interviews and clinical assessments for mood, anxiety, and attention. * Questionnaires evaluating subjective sleep quality (Pittsburgh Sleep Quality Index) and quality of life (WHOQOL-BREF). * A global cognitive screening test (Montreal Cognitive Assessment) and a computerized attention test (Continuous Performance Task). * An overnight sleep study (polysomnography) conducted in a sleep laboratory following an initial adaptation night to objectively record brain waves, sleep stages, oxygen levels, and sleep continuity. Participants in the substance use disorder group undergo supervised abstinence monitoring via periodic clinical check-ins and random urine drug screens. At 1 month and 3 months post-baseline, participants repeat the cognitive tests, quality-of-life questionnaires, and mood/sleep assessments to track recovery trajectories over time (no repeat overnight sleep studies are performed).

A Study of Retinal Imaging to Detect Abnormal Protein Deposits Associated With Alzheimer's Disease

The purpose of this study is to test the use of a screening tool to detect changes in the eye that are associated with Alzheimer's disease in adult participants with memory issues. For each participant, the study will last up to one month and requires one visit to the research site.

taVNS + CCT for Neurocognitive Rehab

The purpose of this study is to investigate whether combining transcutaneous auricular vagus nerve stimulation (taVNS) with computerized cognitive training might help improve thinking abilities and mood. Participants will self-administer these treatment in their homes and undergo pre- and post-treatment assessments of thinking abilities and mood and brain MRIs.

Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers

The goal of this clinical trial is to improve communication among clinicians, patients with memory problems, and their family members. We are testing a way to help clinicians have better conversations to address patients' goals for their healthcare. To do this, we created a simple, short guide called the "Jumpstart Guide." The goal of this research study is to show that using this kind of guide is possible and can be helpful for patients and their families. Patients' clinicians may receive a Jumpstart Guide before the patient's clinic visit. Researchers will compare patients whose clinician received a Jumpstart Guide to patients whose clinician did not receive a guide to see if more patients in the Jumpstart Guide group had conversations about the patient's goals for their healthcare. Patients and their family members will also be asked to complete surveys after the visit with their clinician.

Probiotic Impact on Cognitive Performance, and Metabolic Outcomes in Overweight Young Adults With Impaired Glucose Regulation

This 12-week, double-blind, placebo-controlled trial will examine whether daily supplementation with the Lab4P probiotic can improve cognitive performance and metabolic health in overweight adults aged 18 to 40 with impaired glucose tolerance, a preclinical condition where blood glucose regulation is mildly disrupted. Seventy participants will be randomly assigned to receive either Lab4P or a placebo. The study will assess changes in memory, executive function, and processing speed, along with blood glucose control, cardiovascular function, cholesterol levels, body composition, and markers of inflammation. The study will also analyse changes in the gut microbiome and evaluate the safety and tolerability of the probiotic.

Investigating the Neural Correlates of Cognitive Function in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use

Cognitive impairment is well established in people with psychosis and is associated with cannabis use. The current study will investigate the neurobiological basis of cognitive change associated with 28-days of cannabis abstinence in people with psychosis and non-psychiatric controls with cannabis use. Participants will be randomized to a cannabis abstinent group or a non-abstinent control group and will undergo magnetic resonance imaging at baseline and following 28-days of abstinence. This study will help characterize the neuropathophysiological processes underlying cognitive dysfunction associated with cannabis use and its recovery which may guide the development of novel interventions for problematic cannabis use.

HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH)-Parkinson's Disease (HOBSCOTCH-Parkinson's)

The goal of this pilot study is to assess the feasibility of adapting and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with Parkinson's Disease (PD) The main questions it aims to answer are: 1. Can the current HOBSCOTCH program be adapted for people with PD? 2. Will people with PD experience improved quality of life similar to that found in people with epilepsy after participating in the HOBSCOTCH program? Participants will be asked to: * attend nine, one-hour virtual (online and/or by telephone) HOBSCOTCH-PD sessions with a one-on-one certified HOBSCOTCH-PD coach * complete a brief clinical questionnaire about their diagnosis of PD * complete two questionnaires before and after the HOBSCOTCH-PD sessions about their quality of life and about memory and thinking processes * keep a short daily diary about their PD symptoms and use of the self-management strategies taught in the HOBSCOTCH-PD program * complete a brief Satisfaction Survey after the entire HOBSCOTCH-PD program

Longevity Metrics AI/ML Development Study

This study builds AI models that score diagnostic screening tests, and that predict screening results, clinical judgment, and life expectancy. Longevity Metrics collects a battery of clinical tests on each participant, in whole or in part, and follows every participant for life. The sit-to-rise test and the timed walk are scored by hand today, from a person's count. A model scores the same test from video instead. It also measures what no one can count by eye - speed, asymmetry, steadiness - so one capture yields both the original score and additional measurements, intended to enrich the model and strengthen what it predicts. Every test in a participant's record measures the same body, so the tests are correlated: a test that was performed carries information about one that was not. A model trained across the library learns those relationships and estimates a missing result from the results that are present. Each estimate is checked against records where that part was actually measured, and over decades against death and disease through linkage to the 100-Year Human Aging Study (NCT07563777). The hypothesis is that the full battery can eventually be predicted across modalities with high accuracy using a few short video clips, replacing most in-person screening. That would let preventive screening reach people and places a physical laboratory cannot. How far the input can be reduced is the question this study exists to answer. Every model is a physician-reviewed clinical decision aid until it is cleared by the FDA.

Health Ahead Comparative Effectiveness Study

The Health Ahead Comparative Effectiveness Study is a pragmatic, parallel-arm interventional platform that systematically compares successive changes to preventive health screening on the path toward a fully automated screening system deployable in any environment, including the most isolated and resource-limited communities. Each change is isolated as a single variable against current practice, and every comparison is evaluated with a common set of engagement, behavior-change, experience, cost, and longitudinal outcome measures, so results accumulate on a consistent yardstick across the life of the platform. The first comparison evaluates AI-assisted versus human-only interpretation ("reads") of screening data. Subsequent pre-planned comparisons, added by protocol amendment, evaluate static versus interactive personalized report delivery; mobile community versus fixed laboratory screening; and a hybrid medical-droid-plus-human delivery model versus human-only screening.

100-Year Human Aging Study

The 100-Year Human Aging Study is a prospective, pragmatic, observational trial enrolling participants across fixed clinical sites, mobile clinical sites, and an online participation pathway (current and future) to undergo comprehensive multi-system health screening and longitudinal follow-up until death. Participants are followed to determine whether measurements taken at enrollment and repeated across the lifespan - individually and in combination - predict all-cause mortality, cause-specific mortality, incident serious disease, and functional disability. The study is designed to generate the surrogate endpoint validation data that longevity medicine currently lacks.

Human Observatory Study

The Human Observatory Study is a prospective observational and ecological surveillance study building a continuously-updating world model for human health, disease, and death at the individual and population level. Individual multi-system clinical data from enrolled participants are linked to a continuously-ingested ecological data infrastructure spanning environmental exposures, social determinants, genealogical and family history records, mortality data, and population health databases at geographic resolutions from home address to global scale and beyond. The resulting model generates individual screening recommendations informed by population-level causal estimates, and population-level causal forecasts anchored by present-timepoint individual clinical biology. This linkage creates a feedback architecture designed to improve both simultaneously.

Immersive Nature-Based Wellbeing Program in Older Adults With Cognitive Impairment

This study aims to evaluate an immersive virtual reality program designed to support cognitive and emotional well-being in older adults with mild to moderate cognitive impairment. The program uses nature-based environments combined with mindfulness, cognitive stimulation, and breathing techniques. The goal is to determine whether immersive virtual reality can be a safe and effective tool to improve well-being and support active and healthy aging. The study will be conducted in two phases. In the first phase, virtual environments will be tested in healthy participants using behavioral and physiological measures. In the second phase, 200 older adults with cognitive impairment from day care centers and residential facilities will participate in a group-based immersive virtual reality intervention consisting of 10 sessions. Researchers will assess changes in cognitive function, emotional wellbeing, daily functioning, and quality of life before and after the intervention.

ToolBox Detect: Low Cost Detection of Cognitive Decline in Primary Care Settings

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).

PREsurgical Cognitive Evaluation Via Digital clockfacEdrawing

This study leverages a modernized digital version of a well-known cognitive screening tool to examine pre and post operative cognitive function after surgery in adults age 65 years or more. Machine learning algorithms will be applied to the hospital wide standard of care cognitive metric to identify risk for post-operative cognitive complications.

Efficacy of Gamma Auditory Stimulation for Cognitive Decline in Older Adults (Study 1)

Animal studies have shown that 40 Hz auditory stimulation alone can improve spatial memory and reduce Aβ deposition. However, human studies using 40 Hz auditory stimulation alone remain limited. Therefore, this study will use a randomized, double-blind, placebo-controlled design to investigate the effects of 40 Hz auditory stimulation on cognitive function, EEG activity, sleep quality, and quality of life in older adults with mild cognitive impairment (MCI) or mild dementia.

Vanderbilt Memory and Aging Project

This study will use an observational cohort to cross-sectionally and longitudinally relate vascular health to clinical, imaging, and biological markers of early Alzheimer's disease and cerebrovascular disease among aging adults. Adjusting for relevant clinical covariates, we will test the hypothesis that vascular health is associated with clinical, brain magnetic resonance imaging (MRI), neuropsychological, and cerebrospinal fluid markers of early cerebrovascular and Alzheimer's disease changes (i.e., prior to the onset of significant cognitive decline or dementia). Secondarily, we will examine medical and genetic factors that might mediate associations between vascular health and brain aging, such as inflammatory processes, insulin resistance, and genetic factors (e.g., APOE, a susceptibility risk factor for dementia). Findings will advance knowledge regarding the role that vascular health plays in brain aging.

Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

The purpose of this research study is to see how the brain changes in patients receiving chemotherapy (cytotoxic drug) treatment for colon or rectal cancer at Parkview Cancer Institute. This information will be used to identify helpful tests to diagnose individuals at risk for developing difficulties with thinking and memory due to their cancer treatments.

ME/CFS Brain Fog: Cognitive Rehabilitation Trial

The purpose of this study is to compare two approaches to cognitive rehabilitation in adults with post-viral cognitive syndrome, which resulted in brain fog. All participants will be screened for eligibility prior to participation. Most of the procedures will take place over a phone call or secure telehealth platform (i.e., Zoom). However, participants will be asked to visit UAB on three occasions for blood sample collection and brain imaging (about 2 hours each). Online testing will happen one month before treatment, one day before treatment, one day afterwards, and 6 months afterwards. The study will utilize two different forms of rehabilitation training to improve participants' cognitive ability. Participants will be randomized to one of the two treatment groups. The first treatment approach, known as Constraint-Induced Cognitive Therapy (CICT), will feature (A) web-based computer "games" that trains how quickly individuals process information that they receive through their senses; (B) online training on everyday activities with important cognitive components, (C) procedures designed to transfer improvements in cognition from the treatment setting to everyday life, and (D) a non-invasive form of vagus nerve stimulation, also known as trans-auricular VNS (taVNS). The second approach, known as Brain Fitness Training (BFT), will include (A) web-based computer "games" that train reaction time and eye-hand coordination; (B) in-lab training on relaxation, breathing, healthy nutrition, and healthy sleep, (C) education about how relaxation, breathing, nutrition, and sleep are connected to thinking effectiveness, and (D) taVNS. Approximately 30 hours of training will be conducted over a secure telehealth platform (i.e., Zoom) in the span of two- to four- weeks. A typical CICT session will consist of one hour of gaming, with the bulk of the session being spent on cognitive training of the target behaviors and procedures designed to promote transfer of therapeutic gains to daily life. ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. A typical BFT session will consist of one hour of gaming, training on healthy lifestyle behaviors (i.e., healthy sleep, nutrition, and relaxation habits), as well as procedures designed to promote transfer of behavior changes to daily life. Ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. Training sessions in both conditions will be scheduled based on participants' availability, with the options for sessions scheduled to be as close as every weekday over 2 weeks or as loosely as every other weekday (i.e., over a 4-week span). If a caregiver is available, they will receive training on how to best support participants in their therapeutic program. After the training ends, both groups will receive 4 follow-up phone calls approximately one week apart to promote integration of the gained skills into everyday life. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life.

High-Intensity Exercise to Combat Vascular and Cognitive Dysfunction in Adults With HIV

This is a single site, randomized exercise trial with individuals at least 50 years of age living with HIV who experience suboptimal cognition. The overall goals of this proposal are to determine whether 16 weeks of structured high-intensity interval training (HIIT) can overcome vascular and cognitive impairments (Aim 1) to a greater extent than continuous moderate exercise. Additionally, investigator will seek to identify barriers to engagement in exercise and the participants' perceptions of the study and exercise interventions (Aim 2). This study will enroll 60 participants in Birmingham, Alabama. Data collection will occur at each visit, with baseline data collected at the initial visit with a 3-month follow-up occurring following completion of the intervention.