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Showing 1-20 of 179 trials
NCT03839784
The research team is creating a foundational infrastructure in order to develop a precision medicine approach for geriatric patients who require surgery with anesthesia. The team plans to build the first of its kind comprehensive database of demographic and risk factor questionnaire responses, biobanked blood specimens, intraoperative electroencephalography (EEG), and inclusive cognitive testing throughout patient interaction starting at the preop appointment until a year later. This will be used to create a predictive model of periooperative neurocognitive disorders.
NCT07019402
The goal of this study is to conduct a Stage I pilot study examining the feasibility, acceptability, and preliminary effects of an internet-based, asynchronous mindfulness-based stress reduction program (iMBSR) compared to an internet-based, asynchronous lifestyle education program (iLifeEd), for adults at-risk for Alzheimer's disease (AD). Sixty middle-aged and older adults (aged 50 years or older) with subjective cognitive decline will be randomized to either an 8-week iMBSR program or an 8-week iLifeEd program control group, designed to provide adequate control for placebo effects. Behavioral, neuroimaging, and ecological momentary assessment (EMA) measures of mind-wandering will be administered to determine preliminary effects as a function of engagement in the iMBSR program. AD biomarkers will be examined at pre-training and post-training assessments.
NCT06223672
The proposed research is a randomized crossover trial designed to assess changes in postprandial cognitive function and the gut-brain axis in adults with subjective cognitive complaints who consume 1 study snack per day for 1 week.
NCT07491120
Neurocognitive decline has long been suspected to be a potential long-term complication of coronary artery bypass grafting surgery (CABG), with reports of post-operative cognitive dysfunction by objective testing approaching 15-50% of patients in the year following surgery. To determine the true rate of long-term cognitive dysfunction following CABG compared to percutaneous coronary intervention (PCI or coronary stent placement), we propose a multi-center, two-group, non-randomized study using computer-based customized neurocognitive testing (Cogsate), prior to the procedure and then at 30 days, 1-year and 2-years after revascularization to evaluate cognitive function vital for the maintenance and advancement of professional and personal activities. It is anticipated that the study will document a higher rate of cognitive dysfunction in the CABG group, that the landmark study will provide both the patient and physician with the information necessary to make an informed decision regarding the cognitive risks of CABG versus PCI when faced with the need for coronary revascularization, and that these results will change the clinical practice of recommending CABG as a primary revascularization option for those wishing to preserve cognitive function.
NCT07481903
This clinical trial aims to assess whether electroacupuncture (EA) can alleviate the psychoneurological symptom cluster (including pain, fatigue, insomnia, anxiety, depression and subjective cognitive decline) in breast cancer survivors, and to evaluate the safety of this therapy. Researchers will conduct a randomized controlled trial of electroacupuncture (EA) as compared to sham electroacupuncture (SA) in breast cancer survivors with the psychoneurological symptom cluster who are currently being treated with endocrine therapy. Participants will receive 16 treatments over 8 weeks. The EA group will receive true acupuncture with continuous wave stimulation (2Hz, intensity as tolerated) administered for 30 minutes per session. The SA group will receive sham acupuncture using blunt (non-penetrating) needles that contact the skin without penetration, along with a 30-second transient device activation instead of the 30-minute continuous stimulation. Treatment outcomes for pain, fatigue, insomnia, anxiety, depression and subjective cognitive function will be assessed. The primary outcome is response rate of the psychoneurological symptom cluster after 8 weeks of treatment. Secondary outcomes include changes from baseline in the scores of each of the six psychoneurological symptoms.
NCT03271190
The team "Cognitive intervention, cognitive reserve and brain plasticity", Team 10, is part of the Canadian Consortium on Neurodegeneration in Aging (CCNA). The team's aim is to develop and test a multi-faceted intervention program meant to increase cognitive and brain reserve by providing cognitive stimulation through participation in cognitive training sessions and engaging leisure activities. This will be done with a partially randomized controlled double-blind preference trial with a comprehensive cohort design, in participants with subjective cognitive decline (SCD) recruited in Montreal and Toronto.
NCT07457138
The goal of this multicenter prospective observational cohort study is to better understand the clinical, neuropsychological, and biological characteristics of individuals attending Brain Health Services (BHS) in the Lombardy region. The study focuses on adults with subjective cognitive decline (SCD), functional cognitive disorder (FCD), or "well worried" individuals without objective cognitive impairment. The main questions it aims to answer are: * What clinical, cognitive, and biological differences exist between individuals who are positive versus negative for Alzheimer's disease (AD) plasma biomarkers (p-tau217) at baseline? * What factors predict positivity to AD biomarkers at baseline? * How does communication of biomarker results (risk disclosure) affect psychological well-being shortly after receiving results? * What factors predict longitudinal changes in AD biomarkers over 5 years? * Do baseline biomarkers predict the development of mild cognitive impairment (MCI) or dementia during follow-up? Participants will: * Undergo standard clinical evaluation at their local BHS * Provide blood samples for plasma biomarker analysis (e.g., p-tau217, GFAP, NfL, ApoE) * Undergo neuropsychological testing and cognitive screening * Complete questionnaires assessing psychological impact and risk perception (before and after biomarker disclosure) * Undergo additional center-specific procedures when clinically indicated (e.g., MRI, lumbar puncture, polysomnography) * Be followed annually for 5 years The study plans to enroll approximately 1000 participants across multiple BHS in Lombardy and will follow them for a total duration of 7 years. The results will help clarify the role of biomarkers in early cognitive complaints and support the development of preventive strategies within BHS.
NCT07463391
Subjective cognitive decline (SCD) is considered a preclinical condition associated with an increased risk of dementia and Alzheimer's disease. Effective early behavioral interventions remain limited, and the neurobiological mechanisms underlying cognitive training effects are not fully understood, particularly in culturally specific educational contexts. This randomized, assessor-blinded, controlled clinical trial will enroll 60 individuals with SCD to evaluate the effects of a six-month structured Chinese Classics recitation training program. Participants will be randomly assigned to either an intervention group or a non-active control group. Assessments will be conducted at baseline, immediately post-intervention, and during annual follow-up. Multimodal evaluations will include neuropsychological testing, functional magnetic resonance imaging (fMRI), electroencephalography (EEG), blood biomarker profiling, gut microbiota analysis, and fecal metabolomics. The study aims to examine clinical outcomes and explore potential neurobiological and systemic correlates associated with culturally adapted cognitive training.
NCT03617302
This study investigates the effect of dietary inorganic nitrate supplementation on 1) large elastic artery stiffness and hemodynamics and 2) cerebrovascular function in middle-aged and older adults. Participants will be randomized to consume either nitrate-containing or nitrate-depleted beetroot juice.
NCT06495268
The goal of the HAHA trial is to prove that the treatment of HI and prevention of HI-related cognitive decline are most likely to be effective if HI is approached as a broader neurodegenerative entity with multifaceted manifestations currently unaddressed in clinical practice and managed using a novel individualised data-driven protocol for early hearing rehabilitation. The main hypothesis is that, compared with standard care, the data-driven rehabilitation will likely have broader benefits manifested in three key areas: hearing, cognition, and quality of life and psychosocial outcomes. Participants will be randomized 1:1 to either intervention (individualised data-driven hearing rehabilitation) or control group (standard care hearing rehabilitation). The primary objective of this study is to investigate the effect of an optimized data-driven hearing rehabilitation protocol versus standard care protocol on change in speech perception in noise (SPIN) in older adults with mild to moderately severe sensorineural HI and without dementia.
NCT07444554
The goal of this clinical trial is to learn whether a 12-week high-velocity resistance training program can improve brain blood flow and thinking skills in adults ages 60 to 79 who are at higher risk for Alzheimer's disease and related dementias. Researchers want to understand whether this type of exercise can improve how well the brain regulates blood flow during mental and physical tasks and whether those changes are linked to improvements in thinking ability. The main questions this study aims to answer are whether high-velocity resistance training improves thinking skills such as executive function and processing speed, and whether it improves how blood flow in the brain responds during cognitive testing, changes in blood pressure, and controlled breathing tasks. Participants will complete two study visits at the University of Illinois Chicago, one before the program begins and one after 12 weeks. During these visits, researchers will measure strength, muscle power, and thinking skills. Participants will also complete non-invasive testing to measure blood flow in the brain using ultrasound. During some tasks, participants will walk on a treadmill at a comfortable pace while completing thinking tests. They will wear small sensors to measure heart rate, blood pressure, and breathing. After the first visit, participants will be randomly assigned, like flipping a coin, to one of two groups. One group will take part in supervised resistance training three times per week for 12 weeks at the University of Illinois Chicago. Each session will last about 60 minutes and will be supervised by trained exercise professionals. The other group will continue their usual daily activities for 12 weeks and then return for follow-up testing. Participants in the comparison group will be offered the exercise program after they complete the final study visit. Researchers hope this study will improve understanding of how structured exercise may support brain health in older adults at risk for dementia and help guide future prevention strategies.
NCT06542458
Overall, this study's primary aim is to establish a prospective, longitudinal, observational cohort study of older adults at risk for dementia from under-resourced/underrepresented communities. More specifically, older adults diagnosed with subjective cognitive decline (SCD) or Mild Cognitive Impairment (MCI) during clinical care offered via the Tele-Cog clinic would be recruited for more comprehensive data collection to characterize the clinical presentation and course of illness over multiple timepoints spread out longitudinally.
NCT06245005
Investigators will evaluate feasibility of using a custom 6-game Lumosity brain exercise experience in busy clinical areas to obtain a quick, quantitative measure of cognitive reserve (first gameplay performance \[FGP\]) in older patients presenting for major surgery. Participants in this feasibility trial will serve as a pilot population to estimate postoperative delirium incidence in patients willing and able to complete the brief, self-directed, brain exercise experience on a portable electronic device in various preoperative encounters, and will provide insight into which preoperative encounter (outpatient clinic or morning of surgery preoperative holding) may be more conducive to brief preoperative cognitive evaluations and interventions in future studies. First gameplay performance obtained during study procedures will be compared based upon postoperative delirium status (positive verse negative) to evaluate predictive value of the custom 6-game battery. This will guide future studies of FGP as a quick, quantitative measure of cognitive reserve in older surgical patients, with potentially more utility in preoperative patients than other assessments of cognitive function.
NCT06397469
The goals of the proposed research are to first determine the minimal and/or optimal dose of a digital intervention required for cognitive enhancement, and then to examine the impact of several potential moderators of treatment effects (i.e., cognitive decline, AD polygenic hazard score, cardiovascular risk, and race/ethnicity). This knowledge gained from his high-impact study with transform the field of cognitive interventions, paving the way for a precision medicine model for cognitive enhancing interventions that improve quality of life for older adults and individuals with cognitive deficits at risk of developing dementia.
NCT05599490
This study aims to examine the longer-term benefits of a novel, neuroplasticity-based, computerized and web-deliverable training program (PACR-CT) five years from the initial 10 weeks of training from our Phase II study - Protocol #: PSC-0605-17 (Aim 1) and test the interactive effect of previous training and 10 weeks of booster training (Aim 2). Both the study and the software being investigated meet the criteria of Non-Significant Risk.
NCT06950060
The AMPLIFI study (Adaptive Modulation of Plasticity through Lactate and Fitness Interventions) investigates how short-term aerobic exercise influences brain plasticity and learning in older adults and stroke survivors. The study compares three groups: one performing aerobic cycling at an intensity that elevates lactate levels, one performing low-intensity exercise, and one receiving health education without exercise. All participants will complete motor learning tasks and undergo brain-stimulation testing using transcranial magnetic stimulation (TMS) to assess how well the brain responds to training. The goal is to understand whether different types of exercise can improve brain function, movement, and memory, and how the body's response to exercise (like lactate levels) might support brain health. This research may help identify low-cost, non-invasive interventions-such as targeted exercise-that improve motor and cognitive outcomes in aging and stroke recovery.
NCT07286448
The goal of this clinical trial is to determine whether a home-based digital cognitive-training program called RICORDO can enhance patients' ability to manage their own health and daily life when they have Mild Cognitive Impairment (MCI) or Subjective Cognitive Decline (SCD) and are 50 years of age or older. The main questions it aims to answer are: Does using RICORDO for five weeks raise the Patient Activation Measure (PAM) score more than an at-home paper-and-video education program called S.A.M.B.A.? Does RICORDO also improve cognition, everyday functioning, quality of life and mood compared with S.A.M.B.A.? Researchers will compare individuals who train with RICORDO to those who follow S.A.M.B.A. to determine which approach is more effective. Participants will be randomly assigned to one of the two groups and complete three 45-minute sessions per week at home for five weeks. They will also visit the clinic at the beginning and end of the program to complete questionnaires and take brief thinking tests.
NCT07376135
The goal of this clinical trial is to learn whether a hybrid multidomain lifestyle program can prevent cognitive decline and reduce dementia risk in community-dwelling adults in mid- to late life who are at increased risk of Alzheimer´s disease or related dementias but do not yet have significant cognitive impairment. The main question the study aims to answer are: * Whether the structured hybrid multidomain lifestyle intervention is feasible (e.g., adherence and retention rate), and how well the digital components are accepted and implemented in the intervention group. * Does the intervention reduces the overall burden of modifiable dementia risk factors and improves global cognitive performance compared with usual care. Researchers will compare participants assigned to the tailored hybrid multidomain lifestyle intervention group with those in a self-guided multimodal lifestyle advice group. Participants assigned to the intervention group will receive a plan adjusted to their individual dementia risk profile. A physician trained in motivational interviewing will review their progress continuously. The self-guided multimodal lifestyle advice group will receive rigid but comprehensible lifestyle health advice with reduced access to digital support tools. Participants will: * Complete an initial risk assessment that uses machine-learning triage to identify and prioritize their most important modifiable dementia risk factors. * Receive personalized recommendations for gradual lifestyle change, including physical activity, nutrition, cognitive training, other dementia risk-factor management (e.g. hearing impairment), stress \& sleep management, and social activities. * Use a smartphone and smartwatch to passively collect digital biomarkers and to complete questionnaires at regular intervals, so that physicians trained in motivational interviewing can adapt goals through shared decision making. * Use a study app as the central access point for the program, including educational content, progress tracking, and gamified challenges with social comparison and incentives.
NCT07319663
This study evaluates the effectiveness of a community-based social connection intervention program (SCIP) designed to reduce social isolation and loneliness and improve cardiovascular and brain health among older adults living in rural Ecuador. Loneliness and social isolation are recognized risk factors for poor cardiovascular outcomes, cognitive decline, depression, and reduced quality of life. However, evidence from low- and middle-income countries, particularly in rural Latin American settings, remains limited. This protocol describes a quasi-experimental, longitudinal study conducted in three rural villages that have been part of a long-standing population-based cohort. The intervention will be implemented in one community and compared with two similar communities that will continue receiving usual community activities. SCIP consists of three components: (1) monthly community activities and educational talks designed to promote social participation; (2) monthly peer-support group sessions facilitated by trained personnel; and (3) individualized home-based coaching delivered twice per month, incorporating principles of Social Cognitive Theory and Cognitive Behavioral Therapy. The program aims to strengthen social networks, enhance coping skills, and promote healthier behaviors. Participants aged 60 years and older will be enrolled and followed for 12 months. Assessments will occur at baseline, 6 months, and 12 months. Primary outcomes include changes in social isolation (Lubben Social Network Scale-6) and loneliness (De Jong Gierveld Scale). Secondary outcomes include cardiovascular health (Life's Essential 8), sleep quality (Pittsburgh Sleep Quality Index), cognitive performance (Montreal Cognitive Assessment), depressive symptoms (DASS-21), and quality of life (SF-36). Exploratory outcomes include incident stroke, cardiovascular events, and mortality, monitored through ongoing community surveillance. This study will generate evidence on the feasibility and impact of a culturally adapted, community-based intervention to promote social connection and healthy aging in a resource-limited rural setting. Findings may inform scalable public health strategies for older adults in similar contexts.
NCT07332299
The goal of this clinical trial is to learn if combining brain stimulation with cognitive training can improve thinking skills in older adults who have had a traumatic brain injury (TBI). The main questions are: * Does transcranial direct current stimulation (tDCS) make cognitive training more effective for improving attention, memory, and decision-making? * Is this type of home-based program feasible and acceptable for older adults with TBI? Researchers will compare two groups: one group will receive active tDCS during cognitive training, and the other group will receive sham (placebo) tDCS during cognitive training. Participants will: * Complete computer-based cognitive training exercises (BrainHQ) to practice attention, memory, and decision-making. * Receive either active or sham tDCS during training sessions. * Complete assessments before and after the program to measure changes in thinking and daily functioning.