Clinical Research Directory

Supplementation of Inulin + L. Acidophilus in Elders With T2DM

This study investigates the effects of a symbotic supplement (Inulin + Lactobacillus acidophilus) on cognitive impairment in older adults with type 2 diabetes mellitus (T2DM). Diabetes is a chronic disease characterized by insulin deficiency or resistance, leading to hyperglycemia and long-term complications, including cognitive decline. Cognitive impairment in T2DM patients is linked to oxidative stress, neuroinflammation, and disrupted insulin signaling in the brain. The gut-brain axis plays a crucial role in cognition, with gut microbiota influencing neuroinflammatory processes. Dysbiosis, common in T2DM, exacerbates cognitive decline. Probiotics like Lactobacillus acidophilus and prebiotics like inulin can restore gut microbiota balance, reduce inflammation, and promote brain-derived neurotrophic factor (BDNF) production, improving cognitive function. This randomized, crossover clinical trial will enroll 24 patients aged 50-65 with T2DM and mild cognitive impairment. Participants will be divided into control and experimental groups, with an 8-week intervention phase followed by a crossover. The experimental group will receive 8g of inulin and L. acidophilus daily, while the control group will receive a placebo. Cognitive assessments (MMSE, MoCA), PET-CT imaging, gut microbiota sequencing, and butyrate measurements will evaluate the intervention's effects. The study aims to determine whether symbiotic supplementation can improve cognitive function and metabolic brain activity in T2DM patients. If successful, it may offer an accessible, non-pharmacological approach to mitigating diabetes-related cognitive decline. The research is funded by the Universidad Anáhuac Health Sciences Research Center and international diabetes research organizations.

EFFECTS OF AN OUTDOOR MAT PILATES PROGRAM ON NEUROPHYSIOLOGICAL INDICATORS OF ELDERLY INDIVIDUALS WITH MILD COGNITIVE IMPAIRMENT

Introduction: As individuals age, the quality of cognitive function becomes an increasingly important topic. Elderly people, naturally, due to the aging process, may experience a reduction in cognitive function. Through the Pilates Method, greater cognitive performance can be generated, related to concentration and reasoning. Objectives: to evaluate the effects of practicing Mat Pilates outdoors on the neurophysiological parameters of elderly people with mild cognitive impairment. Materials and Methods: This is a randomized clinical trial study. Initially, the participants will be evaluated and the MoCA neurocognitive test will be applied. Before starting the Mat Pilates protocol, participants will undergo neurophysiological analysis, using electroencephalogram. Participants will undergo a group Mat Pilates protocol in the open air, lasting 60 minutes, which will be developed on two days during the week, on non-consecutive days. For each exercise, a series of 10 to 12 repetitions will be performed for each exercise, with a total duration of 6 weeks. At the end of the care protocol, participants will be reassessed

Impact of Glasses for Vision Problems on Cognitive Function in Rural Older Adults

The aim of this project is to explore whether vision correction can effectively slow cognitive decline in older adults. The primary question it seeks to answer is: Can providing free near and/or distance vision correction glasses to older adults with refractive errors or uncorrected vision, who have normal baseline cognition and hearing, reduce the rate of cognitive decline over 36 months in a cost-effective manner? Researchers will compare the rate of cognitive decline over 36 months between older adults who receive refractive correction and those who do not.

Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss

The purpose of this study is to test whether an investigational drug called solanezumab can slow the progression of memory problems associated with brain amyloid (protein that forms plaques in the brains of people with Alzheimer Disease \[AD\]).

Establishing Normal Cognitive Test Scores for Adults Using a Voice-Enabled Digital Testing Platform Across the Lifespan

Trial weblink: https://www.memoryexam.com/job/norms/ Participants enrolled in this study will complete a single-session, non-invasive, computerized cognitive assessment administered through a secure, web-based digital platform. The purpose of the study is to establish normative cognitive performance data from healthy adults aged 18-100 years and develop age-, sex-, and education-adjusted reference values for the digital assessment platform. This is an observational study and does not involve any therapeutic intervention, investigational treatment, or alteration of routine medical care. Following electronic informed consent, participants will complete a standardized screening questionnaire to determine eligibility. The questionnaire collects demographic information, education, English language proficiency, medical and neurological history, psychiatric history, medication use, substance use, sleep history, and self-reported cognitive concerns. Standardized mood screening instruments (PHQ-9 and GAD-7) are also administered. Individuals meeting predefined exclusion criteria that could significantly influence cognitive performance will not be included in the normative dataset. Eligible participants will then complete a digital cognitive assessment battery using standardized visual and auditory instructions. The platform utilizes automated voice-recognition technology to capture spoken responses and standardized algorithms to score performance, eliminating the need for examiner scoring and ensuring consistent administration across participants. Total study participation, including consent, screening, and testing, is approximately 30 to 45 minutes. The cognitive battery evaluates multiple cognitive domains commonly assessed during neuropsychological examinations. Language abilities are assessed through phonemic and semantic verbal fluency tasks, measuring the ability to rapidly generate words within specified categories. Confrontation naming is evaluated using digitally presented images that participants identify verbally. Learning and memory are assessed through immediate and delayed verbal recall tasks, including recognition memory measures. Attention and working memory are evaluated using forward and backward digit span tasks. Executive functioning and attention are further assessed using a brief computerized problem-solving task. Equivalent alternate versions of selected tasks may be administered to minimize practice effects while measuring the same cognitive domains. All assessments are brief, non-invasive, and completed using spoken responses. The platform automatically records participant responses, response timing, and scoring metrics. Voice recordings are collected solely to support automated scoring and quality assurance. All electronic data are transmitted using encrypted connections and stored within HIPAA-aligned cloud infrastructure. Personally identifiable information is stored separately from cognitive performance data using unique study identification numbers, and only authorized study personnel have access to identifiable information. De-identified data will be used to generate normative reference values. A subset of approximately 100 participants may be invited to complete a second assessment 2-4 weeks after the initial visit to evaluate test-retest reliability. Participation in this follow-up assessment is voluntary. Participants will not receive diagnostic results or individualized interpretations of their performance because the study is intended solely to establish normative reference data. If responses on the PHQ-9 suggest potential acute self-harm risk, the platform will provide crisis resources and notify the study team in accordance with the study safety procedures. The primary outcome of the study is the development of age-, sex-, and education-adjusted normative reference values for the digital cognitive assessment platform, supporting standardized interpretation of future assessments in clinical and research settings.

Moderate-Intensity Aerobic Calisthenics for Rural Elderly With Motoric Cognitive Risk Syndrome

The aging of China's rural population is severe, with both the prevalence and mortality rates of dementia higher in rural areas than in urban areas. Motor Cognitive Risk Syndrome (MCR), as a novel pre-dementia syndrome characterized by both subjective cognitive decline and slow gait, represents a "golden window of opportunity" for the early prevention and treatment of dementia. Currently, there is no specific pharmacological treatment for MCR; non-pharmacological interventions, particularly exercise interventions, are key strategies. Moderate-intensity aerobic calisthenics, which integrates music, dance, and gymnastic elements, is economical, simple, highly engaging, safe, and has demonstrated potential for improving both cognitive and gait function, making it especially suitable for promotion in resource-limited rural settings. However, there is a lack of systematic, theory-guided exercise intervention protocols and effectiveness validation for rural older adults with MCR. Therefore, this study aims to develop and validate a moderate-intensity aerobic calisthenics intervention protocol tailored to this population.

Cerebral Amyloid Imaging Using Florbetapir (AV-45)

This study is aimed at examining the interest of amyloid radiotracer Florbetapir (18F-AV-45) for the etiological diagnosis of poststroke cognitive impairment and dementia

Brain Stimulation and Cognitive Training for MCI

This is a randomized clinical trial of a treatment that combines non-invasive brain stimulation with computerized cognitive training (CCT) for people with mild cognitive impairment (MCI). The form of brain stimulation used in this study is accelerated intermittent theta burst stimulation (iTBS). All participants receive the same amount of iTBS and are randomly assigned to engage in one of two types of CCT. The goals of the study are to see if this combined treatment is feasible and acceptable to people with MCI and whether combined iTBS and CCT improves memory, thinking skills, mood, and daily function.

Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation

Patients will be screened at Intermountain Medical Center and at Intermountain-affiliated anticoagulation clinics in the Salt Lake City region. Patients with non-valvular atrial fibrillation will be considered for study. After written informed consent is obtained, subjects who meet eligibility criteria will be randomized 1:1 to 2 treatment arms: Group 1: Dabigatran etexilate (150 mg BID if CrCL \> 30 mL/min, or 75 mg BID if CrCL \> 15 to 30 mL/min or per USPI; and Group 2: Warfarin (Dose-adjusted (INR 2.0 - 3.0). Assessment of kidney function every 6 months will be done for Group 1. Standard warfarin follow-up and education, based upon system criteria, will be done for Group 2. All subjects will be followed for 24 months, and will be assessed at 1-week, then 3-, 6-, 12-, 18- and 24-months post-anticoagulation visits as well as other visits deem necessary for clinical care. All subjects will undergo protocol-specified laboratory tests and will complete 6 standard, validated questionnaires at each follow-up visit following the week 1 visit, except at the 3-month visit when only one questionnaire will be administered. To determine brain volume and characteristic changes representative of micro-bleeding, the first 10 subjects in each treatment group who are willing and able to undergo the procedure will participate in a MRI sub-study. The cranial MRI will be done at baseline and at 24-months post-anticoagulation on this sub-group.

Dual-site Cross-frequency Coupled Transcranial Electrical Stimulation Modulates Working Memory of Patients With Post-stroke Cognitive Impairment

This clinical trial aims to explore the effect of dual-site theta-gamma cross-frequency coupled transcranial alternating current stimulation in the frontal and parietal region on the working memory ability of patients with cognitive impairment after stroke, and to evaluate the safety of this protocol. The main purpose is to answer the following question: Can dual-site cross-frequency coupled tACS in the frontal parietal region improve the performance of working memory and cognitive-motor dual tasks in stroke patients? What is its mechanism of action? Researchers will compare the effects of real cross-frequency coupled stimuli and sham stimuli to see if the real stimuli can bring better results to patients. Participants will receive 40 minutes of real or sham electrical stimulation once a day for 5 consecutive days. Clinical evaluations (cognitive scales) and fNIRS were conducted respectively before and after stimulation to record the relevant brain activities at rest and during cognitive tasks

The Effect of tDCS Combined With TMS on Cognitive Impairment and Motor Function After Stroke

This clinical trial aims to investigate whether transcranial electrical stimulation (tDCS) combined with transcranial magnetic stimulation(TMS) has an impact on the cognitive and motor functions of stroke patients, and to evaluate the safety of this protocol. The main objective is to answer the following question: Can electromagnetic combined stimulation of the left Dorsolateral prefrontal lobe(DLPFC) improve the performance of working memory, motor function and cognitively motor dual tasks in stroke patients? What is its mechanism of action? Participants will undergo a combined real or sham electromagnetic stimulation of 20 minutes of tDCS and 40 seconds of TMS once a day for 7 days. Researchers will compare the effects of real stimulation with sham stimulation to see if the real stimulation can bring better results to patients. Clinical evaluations (cognitive and motor scales) and functional Near-Infrared Spectroscopy(fNIRS) were conducted before and after stimulation to record relevant brain activities

MRI Technical Development and Applications in Kidney Disease

Magnetic resonance imaging (MRI), as a non-invasive and non-contrast enhanced technique, has the potential to improve patient health care and management. The overall objective of proposed project is to: 1. develop, customize, and optimize anatomic and functional MRI methods, 2. explore the use of MRI methods to study CKD and evaluate post-transplant kidneys, and 3. investigate the potential of MRI in the diagnosis, prognosis, and monitoring of the progression of renal dysfunction. In addition to direct studies of the kidney, brain MRI studies will also be performed to identify the cerebrovascular and cognitive effects of chronic renal function deficiency and medical treatment (e.g. hemodialysis and immunosuppression). The brain and kidneys have similar vascular bed, and both are susceptible to vascular injury, which provides the pathological basis for the widely recognized association of reduced renal function with prevalent cerebrovascular diseases (CVDs) and cognitive impairment (CI). The MRI methods in the brain will be applied to explore the origins for widely observed CVDs and prevalent cognitive impairment (CI) in kidney disease patients.

Influence of Individual Traits on Adaptation Processes in Individuals With Alcohol Use Disorder

Alcohol Use Disorder (AUD) is a chronic condition that affects behavior, decision-making, and the ability to adapt to changing situations. While many studies have examined AUD from medical and social perspectives, less is known about how individual psychological traits influence the way people with AUD respond to uncertainty and adapt their behavior. This study aims to better understand how personal characteristics such as anxiety, self-esteem, sensitivity to reward and punishment, perfectionism, and cognitive abilities may influence adaptation processes in individuals with AUD. Participants receiving usual care at Paul Brousse Hospital will be invited to take part in a single experimental session lasting about 45 minutes. During this session, they will complete: * A computerized learning task in which they respond to visual stimuli and receive feedback on their performance * Standardized questionnaires assessing psychological traits and cognitive functioning The learning task is designed to evaluate how participants adjust their behavior when the rules of the task change unexpectedly. Researchers will measure how performance changes in response to uncertainty and examine how these changes relate to individual psychological characteristics. This research does not modify participants' medical care and involves no medication or invasive procedures. By improving understanding of the cognitive and behavioral mechanisms involved in Alcohol Use Disorder, the study may help advance scientific knowledge about how individuals adapt to uncertainty and inform future research in addiction and mental health.

The BRAIN Intensive Care Unit (ICU) Study: Bringing to Light the Risk Factors

The primary purpose of this proposal will be to identify potentially modifiable risk factors of long-term cognitive impairment (i.e. development of delirium and exposure to sedative and analgesic medications) in ICU patients. The investigators will quantify the independent contribution of these risk factors to the incidence of long-term cognitive impairment, controlling for other established risk factors including age, pre-existing cognitive impairment, and apolipoprotein E (apoE) genotype. Quantifying the contributions of these modifiable risk factors will pave the way for the development of preventive and/or treatment strategies to reduce the incidence, severity and/or duration of long-term cognitive impairment and improve functional recovery for patients with critical illness.

Westlake Aging Cohort (WeAC)

The Westlake Ageing Cohort (WeAC) is a longitudinal cohort study conducted in Hangzhou, Zhejiang Province, China. The investigators aim to enroll 2,800 participants aged 55 years and older for long-term follow-up. The population will include individuals with neurodegenerative diseases or those at the prodromal stage of cognitive impairment, as well as healthy middle-aged and older adults serving as controls. The investigators will collect their sociodemographic, dietary, lifestyle, clinical, and neuroimaging data, as well as biological samples.

Development of a Prediction Model for Delirium After Cardiac Surgery Using a Novel Self-Administered Preoperative Cognitive Assessment Tool

This observational cohort study is designed to validate the CogCheck application as a risk prediction tool for postoperative delirium in patients undergoing cardiac surgery.