Clinical Research Directory

Effect of a Multidomain Intervention Plus Turmeric on the Prevention of Cognitive Decline in People Over 55 Years of Age With Insulin Resistance.

Introduction: The Insulin resistance itself has been recognized as an independent risk factor for dementia development. Insulin plays an important role in the regulation of muscle function and the processes of learning and memory. Insulin resistance is associated with increased inflammation and oxidative stress. These processes are involved in the pathophysiology of neurodegenerative diseases. Thus, reducing IR could have implications for improving metabolism, muscle, and cognitive function. Methods and analysis. The investigators will conduct a randomized, double-blind, placebo-controlled clinical trial in which a multidomain program, including an aerobic and cognitive exercise program, will be evaluated. The latter is an exercise program conducted on a checkered mat and will be randomized to participants receiving turmeric plus black pepper or placebo. Participants are affiliated with the Mexican Social Security Institute (IMSS) and are between 55 and 74 years old. The program will last for 24 weeks; after 52 weeks, it will be repeated. The outcomes that the investigators will evaluate are: global cognitive function, specific cognitive function, and the investigators will evaluate serum markers of inflammation, oxidative stress, and GSK-3beta levels. The effect of the interventions on each variable will be analyzed by ANOVA, and a multivariate analysis study with multiple linear regression will be conducted. Ethics and dissemination of the study: the study was approved by the IMSS National Ethics and Research Committee all participants provided written informed consent prior to their participation.

Physiological Effect of Non-invasive Photobiomodulation on Cognition and Mood in Older Adults With Subjective Cognitive Impairment

Subjective cognitive impairment (SCI) is a non-clinical condition manifesting as a self-reported decline in cognitive function without objective clinical evidence, and is prevalent among older adults and strongly associated with declining mood. This study explores the potential of photobiomodulation (PBM) as a therapeutic intervention for SCI. PBM, using near-infrared light, is a non-invasive neuromodulation approach that has shown promise in improving neuronal function, blood flow, and reducing inflammation in both healthy adults and patients with neurological conditions, including dementia and depression. This study proposes investigating the potential of forehead (tPBM), intranasal (iPBM) and vagal (vPBM) PBM to enhance mood and cognitive function in individuals with SCI as a proof of concept for the future use of PBM as therapy for cognitive decline in general. This study will recruit approximately 80 participants with SCI for the study, and the total expected duration of the participant\'s participation in the study is 5 weeks. The active and sham Neuro 5T device consisting of a headset with a built-in controller, nasal and neck applicators will be used. The nasal and neck applicators each contains a single LED and will be placed into the nostril or neck and secured into place. The headset contains multiple LEDs in a wearable applicator and may be adjusted. The Neuro 5T also contains telemetry features to allow documentation of patient usage of the device. LEDs are semiconductor electronic components that emit light. Participants will be given PBM devices for in-home usage, 2 times a day, 7 days a week, for 5 weeks. Participants will undergo EEG, MRI, cognitive and nasal microbiome assessments before and after the 5-week period.

The Signature of Alzheimer's Disease in Subjective Cognitive Decline

This study focuses on improving early detection of Alzheimer's disease (AD) in patients with subjective cognitive decline (SCD), a preclinical stage of cognitive impairment, in the context of emerging disease-modifying therapies (DMTs). Current biomarkers, such as brain MRI, PET scans, and cerebrospinal fluid (CSF) markers, are highly accurate but costly, invasive, and not widely accessible. The study aims to provide cost-effective, scalable tools for early identification of individuals at risk, enabling personalized assessment and timely DMT administration. Objectives: * Evaluate the accuracy of innovative, easily accessible biomarkers in predicting biologically confirmed AD. * Assess the predictive utility of previously studied methods for SCD patients. * Explore new approaches, including automated speech analysis, to identify cognitive decline. * Evaluate genetic contributions to AD risk. * Integrate data from these various modalities using machine learning to create a predictive model for AD in SCD patients. Study Design: This is a multicenter, longitudinal, low-intervention study conducted at IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy (UO1) and the Center for Research and Innovation in Dementia, Careggi Hospital, Florence, Italy (UO2). Eligible participants are adults with SCD, intact daily functioning, and Mini-Mental State Examination (MMSE) scores \>24. Exclusion criteria include neurological or systemic diseases, major psychiatric disorders, substance use, or prior head injury. Participants undergo: * Detailed medical and family history collection. * Comprehensive neuropsychological, personality, and independence in daily activities assessment * EEG recording in resting state. * Blood sampling for plasma biomarkers (Aβ42, Aβ40, p-tau181, p-tau217, t-tau, NfL, GFAP). * CSF biomarker analysis (Aβ42, Aβ40, p-tau, t-tau). * Genetic analysis of AD-related genes (PSEN1, PSEN2, APOE, TREM2, ABCA7, BDNF, HTT). * Speech recording and analysis using standardized tasks to extract features for automated evaluation. The study expects to create a machine learning-based predictive model combining biomarker, neuropsychological, EEG, speech, and genetic data to improve early detection and guide personalized patient care. Procedures: * Neuropsychological evaluations occur at baseline and two-year follow-up. * Language recordings are conducted in controlled settings using standardized picture description tasks. * EEG is recorded using 21-channel systems. * Blood and CSF samples are collected, processed, and stored at -80°C for subsequent analysis at respective institutional laboratories. * Plasma biomarkers are analyzed with Simoa technology; CSF biomarkers are analyzed using chemiluminescent enzyme immunoassay (CLEIA). * Genetic analyses employ PCR, high-resolution melting analysis (HRMA), sequencing, and capillary electrophoresis as appropriate for specific genes or polymorphisms. The study expects to create a machine learning-based predictive model combining biomarker, neuropsychological, EEG, speech, and genetic data to improve early detection and guide personalized patient care.

The Brain Health PRO Online Risk Factor Reduction Study to Prevent Dementia

This study will recruit participants at risk for dementia to participate in an online educational program called Brain Health PRO (BHPro). The BHPro intervention is designed to address modifiable risk factors for dementia through a 6-month, fully online, educational program conveying the best available evidence for lifestyle changes that can mitigate dementia risk, and foster engagement toward one's own brain health. Achieving lifestyle changes in a diverse Canadian population through online education would be a major achievement in dementia prevention in Canada, with widespread personal and socioeconomic benefits. Eligible participants will be randomly assigned to either start Brain Health PRO immediately or in 6 months (delayed-start control group). All participants will have the opportunity to have access to BHPro for 6 months during the course of the study and will have open access to all content for 12 months following the initial 6-month intervention. Participation will last from 18-24 months depending on group assignment.

Comprehensive Assessment of Neurodegeneration and Dementia

This is a longitudinal observational study recruiting individuals between the ages of 50 and 90 with different types of dementia as well as a comparison group without cognitive deficits. Participants are/will be recruited at sites across Canada and will undergo assessments, neuroimaging, and biological sample collection.

A Study Evaluating the Impact of P-tau217 Blood Biomarker Testing on Early Evaluation and Management of Patients Presenting With Cognitive Complaint

The purpose of the study is to measure the difference in the proportion of participants with prespecified patient management actions between a tested interventional group and a control group.

Comfortage - AD Prevention Strategies

Study is Interventional, cross-sectional, clinical trial without drug and without device

Sleep Apnea and Cognitive Function in Subjects With Subjective or Mild Cognitive Impairment

Obstructive sleep apnea (OSA) is recurrent episodes of partial or complete obstruction of the upper airway during sleep that causes intermittent hypoxia and sleep fragmentation and leads to cardiometabolic and neurocognitive sequelae. Chronic intermittent hypoxia, sleep fragmentation of OSA, and insufficient sleep have been significantly associated with higher risks of neurocognitive impairment, including mild cognitive impairment (MCI) and Alzheimer's disease. Thus, sleep and circadian function might be modifiable neurocognitive impairment factors. The significance of the study is to understand the relationships of MCI with sleep apnea and sleep-related symptoms, which helps pave the groundwork for further research.

Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment

Obstructive sleep apnea (OSA) is recurrent episodes of partial or complete obstruction of the upper airway during sleep that causes intermittent hypoxia and sleep fragmentation and potentially lead to cardiometabolic and neurocognitive sequelae. Chronic intermittent hypoxia, sleep fragmentation of OSA, and insufficient sleep have been significantly associated with higher risks of neurocognitive impairment, including mild cognitive impairment (MCI) and Alzheimer's disease. Thus, sleep and sleep apnea might be modifiable factors to neurocognitive impairment. Positive airway pressure (PAP) is the first line of treatment to maintain open airways for patients with OSA. Improving sleep, sleep apnea and circadian function could be a high-value intervention target to alleviate cognitive impairment and decline in subjects with mild neurocognitive impairment. Amyloid accumulation in brain tissue is a distinct feature of Alzheimers' disease, which is associated with potential impairment of neurocognition clinically. It predicts memory decline in initially cognitively unimpaired individuals. The study explores the associations between sleep apnea, cognitive function and cerebral imaging and the role of PAP therapy on neurocognitive trajectory in these patients with subjective cognitive impairment /mild cognitive impairment (SCI/MCI).

Uppsala-Dalarna Dementia and Gait Project

UDDGait™ is a multidisciplinary research project with the overreaching goal of providing an aid for early identification of cognitive impairment and risk of dementia development, thereby providing a basis for adequate symptom relieving and health promoting interventions. A new concept is investigated for this purpose: a "dual-task-test", which implies the combination of a well-established mobility test (Timed Up-and-Go, TUG) with a simultaneous verbal task (i.e. TUG dual-task, TUGdt). This type of test has been judged as a potential aid for early identification of dementia disease. More research is needed to further examine the test's validity, reliability and predictive capacity. The overall aim is to investigate if TUGdt is useful as an aid for prediction of dementia disease. To ensure the results, the aim is also to evaluate the test's measurement properties and to generate normative reference values of healthy control persons.

Testing the Cog-Fun Aging Program for Older Adults With Subjective Cognitive Decline

The goal of this clinical trial is to learn if the Cog-Fun Aging program helps older adults with Subjective Cognitive Decline (SCD) manage memory challenges and improve their daily lives. The main questions it aims to answer are: * Does the program help participants better understand their cognitive challenges in daily life? * Do participants report using more effective strategies to manage their memory difficulties? * Does the Cog-Fun Aging program reduce negative emotions and self-perceptions related to SCD? Researchers will compare participants who complete the Cog-Fun Aging program with those who do not to determine the program's effectiveness. Participants will: Take part in a 10-week program with weekly sessions. Learn about SCD and how it affects daily life. Practice and monitor strategies to manage memory difficulties.

Effects of a Computerised Cognitive Stimulation Versus Stimulating Leisure Activities

The aim of the study is to evaluate, at the level of global cognition, cognitive neuroconstructs, memory, verbal fluency, ADLs, IADLs, symptoms of depression and anxiety, the effectiveness of a personalised and adapted computerised cognitive stimulation programme (GI1) implemented from Primary Care versus stimulating leisure activities (GI2), in older adults aged 50 years and over with mild cognitive impairment and subjective cognitive impairment living in the community.

Natives Engaged in Alzheimers Research - 'Ike Kupuna

This study will conduct a group randomized trial to test the effects of a hula-based intervention in improving vascular risk factors for ADRD and cognitive complaints and function over 12 months.

CogT pSOPT Intervention Study

(JUSTIFICATION: This is the R33 stage of an NIH funded R21/R33 study. R21 stage (IRB-61727) was focused on intervention development; R33 stage will focus on pilot testing the effect of the intervention. The R21 phase was not considered a NIH defined clinical trial; R33 will be considered a NIH defined clinical trial) The purpose is to develop and test the effect of a "personalized" computer-based cognitive training program. The personalized program tailors the difficulty of the training tasks using a participant's biofeedback (i.e., heart rate) and cognitive performance. Such a personalization will ensure that the participant can perform at his/her ideal training capacity. Participants will be randomized into one of 2 groups and each group will play a different version of computerized training game and have ECG collected to allow subject blinding.

Gait as Predictor of Dementia and Falls. The Gait and Brain Cohort Study

Motor slowing and cognitive slowing are more prevalent as we age. Importantly, the presence of both in an older person increases their risk of having dementia by ten times. Currently, there are no clinically meaningful predictors of progression to dementia in people with mild cognitive impairment (MCI). The main hypothesis is that subtle variations in gait while performing a simple cognitive task is a reliable, easy to perform, and feasible methodology to detect those older adults at higher risk of progression to dementia and also, at higher risk of further mobility decline and falls. Rationale. The Canadian population is aging. According to recent estimates, the proportion of the population aged 65 and older will increase rapidly from 13% in 2005 to 25% by 2031. This increase in proportion is accompanied by a considerable amount of disability and subsequent dependency which has major effects on both the quality of life of older adults and their caregivers, and on the Canadian health care system. An important goal of geriatric medicine is to reduce the gap between life expectancy and disability-free life expectancy by reducing disability and dependency in the later years of life. A substantial portion of this disability stems from two major geriatric syndromes: cognitive impairment and mobility limitation. The ultimate manifestations of these syndromes are dementia and falls. Interestingly, these manifestations often coexist in elderly people: falling is a common geriatric syndrome affecting about a third of older adults each year, and dementia affects about a third of Canadians aged 80 and over. Together, dementia and falls are responsible for much of the discomfort, disability, and health care utilization in older adults and each will become more prevalent as older Canadians are expected to number approximately $9 million by 2031. The combined direct cost of dementia and falls for the Canadian Health System is over $4.9 billion per year. Establishing reliable and easy to obtain predictors to accurately identify MCI patients at highest risk of progressing to dementia is essential first, to determine who will benefit from additional and/or invasive testing and second, to implement preventative strategies, including cognitive training, physical exercises, and aggressive vascular risk factors correction to delay progression. Even a modest one-year delay in dementia incidence could save Canada $109 billion over 30 years.

Long Term Prospective Study of Tai Chi Intervention to Delay the Progression of Subjective Cognitive Impairment

This study evaluates the effects of 3 years-Tai Chi exercise intervention on cognitive function in subjects with subjective cognitive impairment (SCI). Participants will be randomized into the Tai chi training group and the control group.