Clinical Research Directory

A Multi-Dimensional Comparative Study of Exercise Psychological Experience Under AI Fitness Companion and Human Coach Paradigms

This study conducted a comparative analysis of subjective exercise experiences between an AI-based fitness companion and traditional human coaching among 98 university students participating in a standardized 20-minute functional circuit training session. Participants were evaluated across three psychological dimensions: Emotional Resonance (ER), Interactive Dynamics (InD), and Embodied Presence (EP). The results indicated that human coaching elicited significantly higher levels of Emotional Resonance, whereas AI-based companions demonstrated superior performance in Interactive Dynamics. No significant differences were observed in Embodied Presence, suggesting that contemporary AI systems can provide spatial immersion and body-awareness comparable to human coaches. These findings indicate that AI and human coaches offer distinct psychological strengths, suggesting that AI should be viewed as a complementary, scalable tool for exercise guidance rather than a direct replacement for human emotional support.

Non-randomized Clinical Trial on Cognitive Stimulation With Virtual Reality in Patients With Mild Cognitive Impairment

The purpose of this study is to find out if adding virtual reality (VR) to a cognitive training program helps improve cognitive performance in older adults with mild cognitive impairment (MCI). In this study, all participants will take part in a 12-week computer-based cognitive rehabilitation program. One group will also use immersive VR for 15-20 minutes at the end of each session. Participants will attend 2 sessions per week, completing at least 20 sessions and up to 22, depending on the clinic's schedule. Researchers will measure changes in attention, memory, and thinking skills using standard cognitive tests. They will also collect feedback on how participants experience the VR exercises.

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.

The Better, Harder, Faster, Stronger Study

The purpose of this study is to evaluate changes in the electronic Frailty Index (eFI) score following 3-4 cycles of neoadjuvant chemotherapy (NACT) in participants with advanced ovarian and endometrial cancer.

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.

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 - each isolated as a single variable against current practice - on the path toward a fully automated screening system deployable in any environment, including the most isolated and resource-limited communities. Each comparison is evaluated with a common set of engagement, behavior-change, experience, cost, and longitudinal outcome measures, allowing results to accumulate on a consistent yardstick across the life of the platform. The first comparison evaluates static versus interactive personalized health report delivery. Subsequent pre-planned comparisons, added by protocol amendment, evaluate mobile community versus fixed laboratory screening; and a hybrid medical-droid plus human-delivery model versus human-only screening. All participants are simultaneously enrolled in the 100-Year Human Aging Study and the Human Observatory Study, contributing individual longitudinal and population-level causal inference data through those protocols.

Interventions in Mathematics and Cognitive Skills

The purpose of this study is to investigate neurocognitive mechanisms underlying response to intervention aimed at enhancing, and remediating weaknesses in, numerical skills in children, including those with mathematical learning disabilities (MLD).

Psychological Impacts of Exercise Snacks Versus Traditional Exercise: A Comparative Study

This study investigates the comparative psychological impacts of a high-frequency "Exercise Snacks" (ESG) protocol versus a traditional continuous exercise (TEG) regimen on healthy young adults. Utilizing a randomized controlled trial design over a 4-week longitudinal period, 180 participants were allocated into two groups of 90, with a standby recruitment protocol employed to ensure sample size stability. The intervention was standardized to equate total weekly exercise volume at 90 minutes. The TEG cohort performed 30-minute continuous cycling sessions three times per week, whereas the ESG cohort executed 15-minute distributed cycling sessions six times per week. To ensure physiological homogeneity and precision in workload prescription, individual baseline maximal aerobic capacity was assessed via incremental cardiopulmonary exercise testing. Based on these individual thresholds, exercise intensity for both cohorts was rigorously maintained at 40% of their respective maximal aerobic capacity throughout the intervention. Psychometric outcomes were evaluated within 24 hours of the intervention's conclusion, focusing on three dimensions: Perceived Stress, Decision Fatigue and Cognitive Load, and Physical Activity Enjoyment. By applying Lazarus and Folkman's Transactional Model of Stress and Coping, Sweller's Cognitive Load Theory, and Self-Determination Theory, this research examines how fragmented exercise protocols interact with daily workflow and self-regulatory resources. The findings provide critical insights into the real-world viability, behavioral resistance, and psychological divergence associated with high-frequency, fragmented exercise routines compared to conventional models.

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. Thus creating a feedback architecture designed to improve both simultaneously.

Development and Evaluation of Virtual Reality Experiences for Cognitive Stimulation at the Sociosanitary Center El Carme

The goal of this clinical trial is to test a virtual reality (VR)-based program designed for cognitive stimulation in individuals attending the conventional cognitive rehabilitation program at the Day Hospital of CSSC (Centro Sociosanitario El Carme) in Badalona, Spain. The trial will specifically assess VR's impact on declarative memory and executive functions through interactive exercises, as well as attention and episodic memory through VR video stimuli. The main questions it aims to answer are: * Will patients with mild cognitive impairment find the VR program enjoyable and easy to use? * Can VR interventions help improve patients' cognitive functions, specifically attention and memory? * Do healthcare professionals find VR a practical tool for cognitive stimulation in their clinical practice? Participants will undergo a series of 8 sessions, scheduled twice a week to coincide with the conventional rehabilitation appointments. The VR equipment used will be Oculus Quest 2 headsets, offering an immersive experience with hand-tracking technology that simplifies interactions, particularly beneficial for those with mild cognitive impairment (MCI). During the study, participants will: * Engage with a VR-based cognitive stimulation program. * Undergo assessments of the participants´ cognitive functions before and after the intervention. * Provide feedback on the participants´ experience with the VR program. Researchers will analyze the data to see if: * The VR program leads to noticeable improvements in the cognitive abilities of participants. * The program is well-received and deemed beneficial by both patients and healthcare professionals.

100-Year Human Aging Study

The 100-Year Human Aging Study is a prospective, pragmatic, observational trial enrolling participants across fixed and mobile clinical sites 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.

Feasibility Study on the Use of Redormin®500 on Day-time Cognition

Randomized, double-blind, parallel groups, placebo-controlled, baseline/run-in period of 21 days followed by trial period of 21 days, digital phenotyping (sleep, cognitive/psychological parameters and HRV). The aim of this study is to determine the feasibility of investigating the effects of Redormin® 500 on day-time cognition and to assess psychological parameters (subjective cognitive performance, tiredness, mood, stress level, quality of life, motivation), in people with occasional sleep problems. Sleep tracking data will be collected using consumer devices of the Charge series by Fitbit.

Polyphenols and Cognitive Decline

Globally, populations are aging thereby increasing healthcare burden, overall cognitive impairment, and dementia including Alzheimers diseases (AD). The lack of effective treatments makes it essential to develop new strategies for healthy cognitive aging, including interventions to slow or prevent cognitive decline. A traditional Mediterranean diet, rich in polyphenols (PPs), may prevent or delay the onset of cognitive dysfunction in older adults, preserving healthy brain structure and function, and lowering the risk of AD. These effects, mediated in part by gut microbiome-derived PP metabolites, highlight the role alterations in the brain-gut microbiome system play in neurodegeneration. Moreover, high levels of circulating phenyl-y-valerolactones, neuroprotective compounds, exclusively produced by gut microbiota from flavan-3-ol-rich foods (e.g., cocoa, tea, berries) are associated with delaying the onset of cognitive dysfunction in older adults. Intake of such PPs can also change gut microbial composition and function, altering the physiology of the hosts secondary bile acid (BA) pool, affecting regulatory and signaling functions in the brain as well as cognitive decline and AD. The investigators hypothesize that, in older adults with enhanced AD risk, dietary intake of PPs maintains healthier brain features and cognitive function, and that this beneficial effect is mediated by gut microbiota metabolites of PPs and BAs. In this multi-PI application by leaders in the field of brain-gut microbiome interactions, the investigators will conduct a year-long, multi-center, randomized double-blind placebo-controlled study in 300 older adults in the United States (validation sample of 100 from Northern Ireland) who are at enhanced risk of developing AD. Ultimately, the investigators will establish the protective effects of regular dietary PP intake on cognitive function and on brain-gut microbiome interactions, ideally allowing the development of effective dietary regimes to prevent of delay the onset of AD in at-risk elderly, thereby reducing cognitive decline and healthcare costs. Participants will be asked to provide information about their diet, mood, and behaviors via food diaries, physical body measures (e.g. height, weight, etc.), and online questionnaires collected before each in-clinic appointment, as well as monthly online questionnaires. MR imaging will be collected on participants to assess neurocognitive changes as a result of the supplement. Participants will be asked to provide both stool and blood samples. Participants will be randomly assigned to either the Juice Plus+ intervention group or the placebo treatment group and then asked to take their respective supplement 4 pills twice a day. All participants will be asked to come in for 4 in-clinic appointments, including 3 brain MRI scans and 3 cognitive testing appointments, collect 3 stool samples with corresponding diet diaries, and provide 3 blood samples over the course of 12 months. Participants will also meet with a nutritionist 3 times over the 12 months to discuss diet to ensure study eligibility and any questions about the supplement.

Vortioxetine for Cognitive Function in ALK-positive NSCLC Treated With Lorlatinib

This observational study evaluates whether vortioxetine - an antidepressant medication with cognitive-enhancing properties - can reduce the neurological and cognitive side effects associated with lorlatinib treatment in patients with non-small cell lung cancer (NSCLC) harboring ALK or ROS1 gene rearrangements. Lorlatinib is a highly effective third-generation tyrosine kinase inhibitor, but it causes neuropsychological adverse events (NAEs) in approximately 42% of patients, including cognitive impairment, mood changes, and speech disturbances. Vortioxetine has demonstrated cognitive improvement in depressed patients and in preclinical models of androgen deprivation therapy-induced cognitive impairment. Twenty-four adult patients with ALK/ROS1-positive NSCLC receiving lorlatinib as standard care and prescribed vortioxetine (10-20 mg/day) for NAE management will be enrolled. Comprehensive neuropsychological assessments and quality-of-life questionnaires will be conducted at baseline, week 6, week 12, and month 6 to document changes in cognitive function, depressive symptoms, and quality of life.

The ACDC Study Assessing Cognitive Deterioration in COVID-19

The long-term impact and effects of COVID-19 are still being determined. However, what is clear, is that some people are still struggling following a period of illness with COVID-19. Now known as 'long covid' or 'post covid-19 syndrome', people are not only experiencing physical symptoms like fatigue and breathlessness, but also psychological difficulties, as well as cognitive changes often referred to as 'brain fog'. This can include symptoms, such as changes in memory, difficulties with organisation and problem solving, as well as the ability to concentrate. Evidence from other research areas suggest that these changes could be due to shrinkage in areas of the brain that control functions like memory and concentration. There are also connections between different brain areas that work together to perform tasks such as remembering and concentrating, and these areas may also be affected by COVID-19. The purpose of this study is to scan the brains of patients reporting cognitive changes having been hospitalised with COVID-19 infection to see if any of these areas or connections have changed after infection and whether this might explain these cognitive changes.

Up-2 Study: Cognitively Engaging Walking Exercise and Neuromodulation to Enhance Brain Function in Older Adults

Declines in cognitive function and walking function are highly intertwined in older adults. A therapeutic approach that combines complex (cognitively engaging) aerobic walking exercise with non-invasive electrical brain stimulation may be effective at restoring lost function. This study tests whether electrical stimulation of prefrontal brain regions is more beneficial than sham stimulation.

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.

MOBility Disorders Assessment in Patients With Mild COGnitive Disorders

Mild cognitive impairment (MCI) is defined by lower performance in one or more cognitive domains with preservation of independence in functional abilities. Sixteen percent of community-dwelling older people (over 65 years) live with MCI. They are both cognitively and physically vulnerable. From a cognitive perspective, they are susceptible to converting to the dementia stage at an annual rate of 10%. From a physical perspective, the proportion of slow gait or neurological gait abnormalities can reach 46% in the population with MCI. Falls in turn increase the risk of accelerated cognitive decline and the risk of institutionalization. In the absence of a curative treatment for dementia, it is essential to have an effective and personalized prevention strategy by identifying the predictive factors for falls in this at-risk population with MCI. The research goals of this project are 1) to identify specific predictors for falls in clinic attendees with MCI in preparation for a definitive, fully powered study across France, and 2) to demonstrate the feasibility of a pragmatic fall risk assessment in MCs, whatever its setting and location. We aim to prospectively follow-up people diagnosed with MCI and aged above 65 years old in four MCs in France (three in the North (one community-based MC), and one in the Centre) for one year.

MICBT for Non-underweight Adults With Eating Disorders

Eating disorders (ED) are severe but treatable conditions, but there are large margin for improvements in terms of efficacy and adherence. There is room to explore new treatment options who are either more capable to retain patients in therapy, more effective. Alternative their efficacy may match the ones of current available treatments but offer new options to ones that did not respond to available therapies. Here the investigators explored if a combination of CBT-focused plus Metacognitive Interpersonal Therapy (MIT) is an empirically supported therapy for personality disorders and could be a new viable treatment option for non-underweight ED. MIT targets some aspects of ED such as poor awareness of mental states and maladaptive interpersonal schemas that are not included in the transdiagnostic model underlying the most investigated empirically supported treatment for ED that is CBT-E. It is reasonable therefore that targeting these aspects of psychopathology can be a path to treatment adherence and effectiveness

Metacognitive Interpersonal Therapy Across Transdiagnostic Eating Disorders, Including Underweight

The goal of this clinical trial is to assess if Metacognitive Interpersonal Therapy for Eating Disorders (MIT-ED) is effective for treating various forms of Eating Disorders (ED) and reducing dropout rates. The trial will also evaluate its feasibility and outcomes in a patient group including also underweight participants. The main questions it aims to answer are: * Does MIT-ED improve eating disorder symptoms and reduce overall maintenance factors, as alexithymia, emotional dysregulation, maladaptive perfectionism, and self-esteem? * Is MIT-ED effective in reducing the severity of personality disorders and associated global psychiatric symptoms? * What are the dropout rates and adherence levels for patients receiving MIT-ED? Participants will: * Undergo an initial screening to confirm eligibility, including a comprehensive clinical interview and assessments based on inclusion and exclusion criteria for the study. * Receive up to 40 individual sessions of MIT-ED, each lasting 50-60 minutes, over a period of approximately 10-12 months. * Attend regular assessment focusing on eating disorder symptoms (Eating Disorder Examination Questionnaire, EDE-Q 6.0, and ED Interview, EDE), emotional dysregulation (Difficulties in Emotion Regulation Scale, DERS), alexithymia (Toronto Alexithymia Scale-20, TAS-20), and self-esteem (Rosenberg Self-Esteem Scale, RSES). Assessment will be conducted at baseline (before starting MIT-ED sessions), after 20 MIT-ED sessions (approximately after 5 months), post-treatment (approximately after 10 months), and at 3 months follow-up. A longer 12-months follow-up is planned. Researchers will evaluate the effectiveness of MIT-ED based on treatment adherence, symptom improvement, and the reduction of maintenance mechanisms associated with Eating Disorders. Positive results could support the design of a larger, controlled Randomized Clinical Trial (RCT).

Effects of Turning Based Dual Task Training on Balance and Mild Cognitive Impairment in Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathy (DPN) is a common complication of diabetes, characterized by impaired sensory and motor function, often leading to balance dysfunction and an increased risk of falls. Additionally, individuals with DPN are at heightened risk for mild cognitive impairment (MCI), which further compromises functional independence. This study aims to determine the effects of turning-based dual-task training compared to conventional dual-task training on balance, cognitive function, and fall risk in individuals with DPN. Pre- and post-intervention assessments will be conducted using the Berg Balance Scale (BBS), Montreal Cognitive Assessment (MoCA), and Timed Up and Go Test (TUGT) to evaluate balance, cognition, and fall risk respectively.

Minocycline In Neurocognitive Outcomes - Sickle Cell Disease

Sickle cell disease (SCD) is a common, inherited blood disorder that primarily affects people of African Ancestry. It has a lot of complications including neurological complications. The neurological complications of SCD are particularly devastating and lead to cognitive decline even in the absence of overt brain injury. In such cases, it is thought that inflammation in the brain maybe partly responsible for the cognitive decline. The main reasons for this research study are to see 1) how safe and 2) how well minocycline works to try to stop/reverse cognitive decline in people with SCD. People with SCD are at risk for changes in their brain over time that can cause problems with learning, memory, and attention. Part of the reason for this is inflammation within the brain. Minocycline may be able to stop these brain changes by stopping this brain inflammation. Minocycline is a second-generation tetracycline antibiotic that has been shown to both inhibit neuroinflammation and improve cognitive function in a variety of neurodegenerative and psychiatric disorders but has not yet been studied in SCD. We are proposing here, a pilot double-blinded, randomized controlled trial to examine the tolerability and early efficacy of minocycline in adults with SCD at two dosing regimens (200 mg and 300 mg daily) versus placebo over one year. Participants will undergo a neuropsychological exam using the NIH Toolbox Cognition Battery at both study enrollment and exit (after one year) to assess for changes/stability of cognition. Participants will receive monthly phone calls/text messages to assess for adverse events and will be seen every three months for pill counts and routine laboratory monitoring. The primary outcome will be a comparison of adverse events across the two dosing strategies versus placebo. Early evidence for cognitive benefit will also be assessed from the results of the NIH Toolbox.

Network-targeted Theta-burst Stimulation for Episodic Memory Improvement in Mild Cognitive Impairment

The purpose of this study is to see if stimulation of the brain can improve memory. The investigators will use a device called transcranial magnetic stimulation that can stimulate and activate a specific part of the brain that is important for memory. The study will enroll MCI subjects and subjects with subjective memory complaints who will be randomly assigned to receive active or sham brain stimulation. 'Blinded' or 'sham-controlled' means that the subject will not know whether the treatment they receive is the active treatment or the non-active stimulation. In the 'sham' condition, the stimulator will turn on but will not actually be stimulating the target brain region.

bWell-D Pilot Randomized Controlled Trial

The goal of this clinical trial is to determine the acceptability, feasibility, and validity of the bWell Cognitive Care Platform for Depression (bWell-D), a novel Virtual Reality (VR) cognitive assessment and remediation tool, in depressed populations. The main questions are: * Do patients with Major Depressive Disorder (MDD) find the bWell-D cognitive assessment battery and protocol feasible, tolerable, and acceptable? * Do patients with Major Depressive Disorder (MDD) find the 8 week bWell-D remediation protocol feasible, tolerable, and acceptable? Following initial cognitive assessment, researchers will assess feasibility outcomes in the bWell remediation arm to a VR scenes experience arm to learn more about the feasibility of bWell for cognitive assessment and remediation. Patients will: * Complete an initial bWell cognitive assessment session * Randomized to either receive bWell cognitive remediation or a VR scenes experience twice a week for eight weeks * Complete cognitive/functional/clinical assessments and EEG at baseline, midpoint and endpoint of the remediation protocol, as well as two MRI scans and measures of tolerability, engagement, and enjoyment