Clinical Research Directory

Oral Motor and Cognitive Dual-Task Training (OMCDT) Program for Improving Oral and Cognitive Functions Among People With Oral Frailty

The goal of this clinical trial is to proposes a novel Oral Motor and Cognitive Dual-Task Training (OMCDT) program that combines both oral motor exercises and cognitive tasks to improve brain and oral function at the same time. It will also learn about the safety of drug ABC. The main questions it aims to answer is: Does the OMCDT training can improve the oral and cognitive functions? Participants will: Take the OMCDT training once a week for 32 weeks Visit the lab twice in the intervention period (16-week, 32-week) for checkups and tests

Temporal Interference Stimulation Combined With Tai Chi for Mild Cognitive Impairment

This study aims to evaluate whether individualized hippocampal transcranial temporal interference stimulation (tTIS) combined with Tai Chi training can improve cognitive function and dual-task performance in individuals with mild cognitive impairment. Participants will be randomly assigned to receive either active or sham individualized tTIS combined with Tai Chi training for 8 weeks. The study will also investigate changes in brain structure and function using neuroimaging and assess whether the intervention effects are maintained during follow-up.

Assessing Treatment With High-phenolic EVOO Supplements for Neurovascular Activity

The goal of this clinical trial is to determine whether the extra-virgin olive oil (EVOO) phenolic dietary supplement can improve memory function and modulate biomarkers among individuals with mild cognitive impairment (MCI). The main questions it aims to answer are: * Does dietary supplementation with EVOO phenolics improve cognitive function? * What would be the effect of the EVOO dietary supplement on other MCI-related biomarkers, including vascular function and biological pathways? Researchers will compare the EVOO dietary supplements with a placebo (a look-alike substance that contains no EVOO phenolics) Participants will: * Take EVOO dietary supplements or a placebo daily for 6 months * Visit the study site during the 6-month study for screening and testing.

Rural Veteran and Care Partner Walking Program

The purpose of this study is to determine the practicality/feasibility of a virtual physical activity intervention to improve daily steps for Veterans with mild cognitive impairment and their care partners living in rural areas. Participation includes: * Complete a 6-week walking program * Complete 2 testing visits (1 before and 1 after the 6-week walking program) consisting of various surveys and questionnaires * Complete a semi-structured interview on feasibility and feedback of the intervention * Potentially serve on an advisory board with the research team to assist with implementing the walking program adaptations

China HEalthy Aging and Dementia Study (HEAD)

The China HEalthy Aging and Dementia (HEAD) study is a large-scale, community-based, multi-center prospective cohort study covering eastern, northern, southern, and central-western regions of China. By integrating comprehensive clinical, neuroimaging, biospecimen, and multi-omics data, the study aims to advance the early prediction and diagnosis of Alzheimer's disease and related dementias (ADRD) and provide a foundation for future intervention studies in the Chinese population. The primary aims of the China HEAD study are as follows: 1. To establish a community-based prospective cohort by recruiting over 20,000 participants from eastern, northern, southern, western, and middle regions of China. 2. To build a comprehensive biobank by collecting demographic information, disease history, cognitive function, physical measures, electrophysiologic data, multimodal imaging data, as well as biospecimens and derived multi-omics data. 3. To conduct early prediction and diagnosis studies for ADRD and support future intervention studies based on the above-mentioned cohort and biobank.

Feasibility Study of 'SuperBrain BOOM' for Mild Cognitive Impairment Patients

The goal of this clinical trial is to learn whether a mobile-based personalized physical activity program called SuperBrain BOOM is safe and works to improve cognitive function, physical performance, mood, and quality of life in older adults (ages 50-85) with mild cognitive impairment (MCI). The main questions it aims to answer are: Can SuperBrain BOOM be safely and effectively used by people with MCI? Does the program help improve cognitive and physical function? Do participants stay engaged and complete the program as expected? Researchers will compare: A mobile intervention group using SuperBrain BOOM (on tablet or smartphone) A control group receiving usual care Participants will: Use a tablet or smartphone to follow a personalized physical activity program for 12 weeks Complete clinical assessments on cognition, physical ability, mood, and nutrition Be monitored for safety and program adherence using automatically collected data

Loneliness as Risk Factor for Dementia

This study aims to determine whether loneliness is associated with a higher incidence of dementia in older adults with a prior diagnosis of mild cognitive impairment after 12 months of follow-up.

Combating Alzheimer's Through Sleep and Exercise

The Combating Alzheimer's through Sleep and Exercise (CASE) study is an exploratory, hypothesis-generating trial designed to: (1) assess whether improvements in sleep are associated with improvements in cognitive performance and cardiovascular and metabolic health; (2) evaluate the effects of structured, moderate-level aerobic and anaerobic exercise on cognitive performance and cardiovascular and metabolic health; (3) examine the combined, potentially synergistic effects of both interventions on cognitive performance and cardiovascular and metabolic health; and (4) investigate the role of light exposure as a potential modulator of sleep parameters.

Aging Stereotypes and Prodromal Alzheimer's Disease

Because of the lengthening of life expectancy, more and more people are concerned with the effects of aging on their mental faculties (e.g., memory decline) and with the possibility of getting Alzheimer's Disease (AD) or other forms of dementia. This increasing awareness of AD has already resulted in a growing demand for neuropsychological testing. AD's research also emphasizes the need for early screening to improve the prediction of the disease progression and the efficacy of any future therapy. Such a drive to screen for pre-dementia raises the challenging issue of frontline identification of individuals in the preclinical or early clinical stages of AD. Mild Cognitive Impairment (MCI) is typically considered to be the prodromal state of AD, and is therefore at the core of the drive for early screening. Moreover, Pre-MCI so called SCI (Subjective Cognitive Impairment) can precede AD for 15 years. However, many individuals diagnosed with MCI do not convert to AD, some remaining stable and others even reversing back to normal (with rates of reversion to normal varying from 4.5% to as high as 53%). This over-diagnosis bias, which has been largely overlooked, is at the core of the present project at the interface of human and life sciences. Here, we argue that an important source of overdiagnosis in the prodromal state of AD comes from negative aging stereotypes (e.g., the culturally shared beliefs that aging inescapably causes severe cognitive decline and diseases such as AD) that permeate neuropsychological screening. There is ample evidence in the laboratory that such stereotypes contribute to the differences observed in the healthy population between younger and older adults in explicit memory tasks. Additionally, three pilot (lab) studies specifically conducted for the present ANR project showed that the threat of being judged stereotypically undermines the controlled use of memory of healthy older adults and simultaneously intensifies their automatic response tendencies, resulting in impaired memory performance. The present proposal goes several steps further by examining for the first time whether aging stereotypes are powerful enough to implicitly permeate the clinical neuropsychological testing and thus inflate memory deficits in older adults judged "at risk" (based on either epidemiological criteria or memory complaints), resulting in false-positive detection of SCI and MCI. This provocative hypothesis will be tested while 1) using biomarkers of neurodegeneration to distinguish false-positives from true MCI, and 2) using biomarkers of stress to examine whether and how aging stereotypes can lead to acute physiological stress during neuropsychological testing. This innovative project has the potential to offer new recommendations to improve the diagnosis accuracy of prodromal state of AD, with positive consequences for older people's wellbeing.

Fuzhou Aging Brain Health Initiative

The goal of this observational study is to learn about the pathophysiological characterization and evolutionary patterns of Alzheimer's disease (AD) in older adults in Fujian Province, China. The primary purposes are as follows: 1. establishment and follow-up of cohorts in the general population and populations with cognitive impairment; 2. investigation of risk factors and evolutionary patterns of AD pathological characteristics; 3. construction and validation of AD digital phenotypes based on multi-dimensional digital-intelligence screening; 4. exploration of AD-related risk genes and their mechanisms of action; 5. development of novel technologies for plasma biomarkers and PET imaging for the accurate diagnosis of AD.

InRAD Observational Study

The goal of this international observational study is to evaluate long-term disease outcomes and treatment safety in people with Alzheimer's disease (PwAD), by collecting real-world data from routine clinical practice across global clinical centers. The InRAD Registry Observational Study has several aims: * To collect medical information for many years from a large group of people with Alzheimer's disease. This will be used for research, which will support improved understanding about the disease. * To enable researchers to look at the effectiveness, usefulness and safety of treatments for Alzheimer's disease. * To enable researchers to answer similar research questions and compare results in many different areas of the world. People with Alzheimer's disease who meet the eligibility criteria and agree to participate in the Study will be asked to visit their doctor (e.g. psychiatrist, geriatrician, or neurologist) at least once a year, or as frequently as is needed for their care. During or after their appointments they may be offered assessments, tests, medications, and treatments as determined by their doctor and their team. This is an observational data collection.

Postsurgical Pain and Opioid Use in Older Adults: Effects of Mild Cognitive Impairment

Mild cognitive impairment (MCI) affects a substantial proportion of older adults undergoing major surgery and may alter pain processing, pain experience, and opioid use after surgery. This prospective observational cohort study will compare older adults with MCI and cognitively intact older adults undergoing major orthopedic and complex spine procedures. Participants will undergo preoperative assessment of cognitive function, quantitative sensory testing, heart rate variability, clinical pain, and biomarkers associated with Alzheimer's disease risk. Postoperative pain trajectories, opioid use, pain responsiveness, and cognitive outcomes will be evaluated for six months following surgery. The study aims to determine whether MCI is associated with differences in postoperative pain and opioid use outcomes and whether APOE4 status and plasma amyloid beta 42/40 ratio contribute to observed differences.

Deep Brain Stimulation Guided by Brain Mapping to Treat Cognitive Impairment

This trial is a 12-month safety and feasibility study, enrolling up to six participants. These participants will serve as their own controls, structured in multiple parts that follow an initial short-term stereo electroencephalography (SEEG) mapping period. During this trial we aim to demonstrate the safety of acute and chronic network-guided stimulation in Mild Cognitive Impairment by evaluating adverse effects, tolerability, and feasibility during both the short- term SEEG mapping phase and subsequent permanent DBS therapy. In addition to safety measures, therapeutic results as follows are to be tested for: (1) Develop patient-specific stimulation parameters for the treatment of MCI, as well as develop and test memory state classifiers by enrolling six individuals to undergo intracranial mapping (SEEG). We will use targeted memory tasks to generate neural data needed for state distinctions, and conduct a systematic parameter search to identify and develop optimal settings for each patient. (2) Assess efficacy of open loop stimulation by delivering a fixed open loop protocol based on the parameters discovered earlier, while SEEG electrodes remain in place, and testing the efficacy of the trained classifier to detect favorable brain states. (3) Evaluate chronic DBS therapy by implanting a permanent system in participants who show an acute beneficial response to assess long term outcomes. (4) Assess therapeutic outcomes and refine protocols by measuring reductions in memory-related impairment. The above findings will guide further refinement of the device and protocol.

Effects of Tadalafil on Cognition and Cerebral Hemodynamics in Elderly Patients With Mild Cognitive Impairment

The goal of this clinical trial is to determine if taking four weeks of a daily low dose of tadalafil is possible and safe in elderly males and females with mild cognitive impairment. Additionally, we aim to determine if this drug that improves blood flow can improve cognition and functionality of the blood vessels in the brain. The main questions the trial aims to answer are: 1. Will elderly patients with mild cognitive impairment be able to tolerate taking a daily, low dose (5 mg) of tadalafil? 2. Does 5 mg of daily tadalafil improve cerebral vasomotor reactivity (i.e. vascular function) and cognition? Participants will to: 1. Answer questions about your health 2. Take three short thinking and memory tests 3. Have your blood pressure and heart rate checked 4. Have an electrocardiogram 5. Fill out a thinking questionnaire 6. Fill out a suicidality questionnaire 7. Have a brain blood flow test 8. Get three blood tests throughout the study 9. Take tadalafil once daily 10. Monitor your blood pressure twice daily 11. Record any side effects 12. Return after 4 weeks and repeat testing

Remote Digital Assessments for Cognitive Disorders

Memory and thinking problems in older adults, including mild cognitive impairment (MCI) and Alzheimer's disease (AD), can be difficult to assess promptly because evaluation often depends on in-person specialist visits. MonitorCog-AI is a computer-based platform designed to provide a more accessible way to assess and monitor cognitive changes using standard computers or tablets. Artificial intelligence (AI) will be used to analyze the digital information collected by the platform and examine whether combining several types of measures improves assessment of cognitive impairment. The study will include 60 adults aged 50 years and older: 20 healthy adults, 20 adults with MCI, and 20 adults with AD. Participants will be assessed at baseline, 6 months, and 12 months. At each timepoint, participants will complete one clinical assessment and one digital assessment. The clinical assessment will include standard measures of memory and thinking, an assessment of daily functioning, and a brief recording of brain electrical activity. The digital assessment will take approximately 60-80 minutes and will assess five areas: cognition, eye movements measured using a webcam, language, speech, and fine-motor performance measured using a mouse. At baseline, the digital assessment will be completed in the clinic; at 6 and 12 months, it will usually be completed remotely at home. The study has three main goals. First, it will determine whether MonitorCog-AI is feasible, acceptable, easy to use, and not overly burdensome for repeated assessment. Second, it will examine how well AI-based analysis of the digital measures distinguishes healthy adults, adults with MCI, and adults with AD, and whether combining several types of digital information performs better than any single type alone. Third, it will examine how digital measures change over 12 months and whether these changes are related to changes in clinical measures of cognition and daily functioning.

A Prospective Cohort Study of Multimodal Biomarkers and Progression From Mild Cognitive Impairment to Dementia

This prospective, longitudinal observational cohort study will examine clinical, cognitive, blood-based, and neuroimaging features across the cognitive continuum. It will also assess whether these measures can distinguish disease stages and predict progression from mild cognitive impairment (MCI) to dementia. The study will enroll 600 participants. These will include 200 individuals without cognitive impairment, 200 with MCI, and 200 with dementia. The MCI group will comprise participants with Alzheimer disease-related MCI and non-Alzheimer disease-related MCI. The dementia group will be further characterized by clinical subtype (Alzheimer disease-related versus non-Alzheimer disease-related). At baseline, participants will undergo clinical evaluation, neuropsychological assessment, blood collection, and multimodal magnetic resonance imaging. Neuropsychological assessment, blood collection, and magnetic resonance imaging will be repeated at 12 months. No treatment will be assigned. The analyses will compare biomarker profiles across the study groups and examine relationships among blood biomarkers, neuroimaging findings, and cognitive performance. Clinical, cognitive, genetic, blood-based, and neuroimaging measures will then be integrated to develop diagnostic and risk-prediction models.

CMN LIFU for Enhanced Glymphatic Clearance in Amyloid-Positive MCI

The goal of this clinical trial is to learn if a wearable ultrasound device, called ATTN201, is safe and easy to use. The study is for adults ages 65 and older who have mild cognitive impairment (MCI) and a buildup of a protein called amyloid in the brain. Amyloid buildup is an early sign of Alzheimer's disease. The ATTN201 device sends low-intensity sound waves to a deep area of the brain that helps control sleep. The aim is to boost deep-sleep brain waves. These brain waves may help the brain clear away waste, including amyloid. The main questions it aims to answer are: 1. What, if any, issues do participants have when using the ATTN201 device? 2. Can participants complete the full study schedule? Researchers will compare focused ultrasound to unfocused ultrasound. Unfocused ultrasound is a look-alike treatment. It feels and sounds the same but is not aimed at the brain target. The comparison will show if the focused treatment changes sleep brain waves, blood markers of Alzheimer's disease, or memory and thinking. Participants will: * Visit the study site for memory and thinking tests, blood draws, a health check, and MRI scans of the brain * Record their sleep at home for at least 5 days with a sleep diary, a watch-like sensor, and a headband that measures brain waves * Be assigned by chance to focused or unfocused ultrasound * Take part in 10 nap sessions over 2 weeks while wearing the device, at the study site or at home * Return for a final visit to repeat the first tests, and may return for an optional visit 3 months later

Digital Lifestyle Coaching for Alzheimer's Disease Prevention in APOE4 Carriers

Wellderly Brain is a randomized, direct-to-participant trial evaluating whether a virtually delivered, multidomain lifestyle coaching intervention can favorably impact plasma biomarkers of Alzheimer's disease (AD) in adults aged 60-80 with APOE4 positivity or elevated polygenic risk. Participants are recruited through 23andMe and enrolled via the MyDataHelps platform. Following genetic eligibility screening, 1,200 participants will be randomized to either a digital lifestyle coaching arm (UCardia) or an education-only control arm. The intervention consists of 16 virtual coaching sessions delivered over 52 weeks. All participants will wear an Oura Ring for continuous health monitoring and provide dried blood samples at baseline, 6 months, and 12 months for plasma p-tau217 and proteomic profiling via the NULISAseq CNS Disease Panel. Saliva samples will be collected for epigenetic aging analysis. The study duration is 14-16 months per participant.

Biomarker-based Trial of NPC-1 for Alzheimer's Pathology

This early phase, open label, single arm clinical trial will determine the intraindividual safety, tolerability and effects of NPC1 (parthenolide and ipriflavone) on blood-based biomarkers of Alzheimer's disease (AD) pathology among adults with subjective cognitive decline, mild cognitive impairment, or Alzheimer's disease and objective indicators of seeding AD pathology

Study of Bedroom Environment Sleep Intervention at Home for Older Adults Living Alone With Memory Concerns

This is an eight-week pilot research study designed to test whether simple changes to the bedroom environment along with brief sleep hygiene strategies, can improve sleep in older adults who live alone, have memory concerns, and experience insomnia symptoms. Older adults may be eligible to participate. The intervention will take 8 weeks, which includes 1-2 in-person visits from the research team at the participant's residence (evaluate the bedroom environment, install participant-agreed bedroom changes, deliver target sleep hygiene strategy) and 2 virtual or telephone calls (support environmental and sleep hygiene strategies) over 8 weeks. Sleep and environment data will be collected at screening/baseline, mid-intervention (4-week) and post-intervention (8-week)

Transcranial Direct Current Stimulation Combined With Tai Chi for Dual-Task Mobility and Cognitive Function in Older Adults With Cognitive Decline

This randomized clinical trial evaluated the effects of transcranial direct current stimulation (tDCS) combined with Tai Chi on dual-task mobility, cognitive function, and physical function in older adults with mild cognitive impairment or self-reported memory concerns. Participants were randomly assigned to receive either Tai Chi combined with tDCS or Tai Chi alone for 8 weeks. Assessments were conducted at baseline and at Weeks 8, 20, and 32. Outcome measures included dual-task Timed Up and Go (DT-TUG) time, single-task TUG, dual-task cost, Montreal Cognitive Assessment-Basic (MoCA-B), Digit Span Test, balance, gait, lower-extremity function, health-related quality of life, sleep quality, anxiety, and depressive symptoms.

Evaluation of a PMT Rehabilitation Nursing Plan for the Older Adults With MCI to Promote Cognitive Health

With the aging of the population, the number of older adults with mild cognitive impairment (MCI) has increased year by year, which has caused serious social and family burdens. At present, the existing drug treatment effect is limited. Studies show the application value of non-drug treatment in the older adults with mild cognitive impairment. Psychomotor Therapy (PMT) is now widely used in European countries and has formed an independent scientific system. Therefore, this topic pays attention to older adults with mild cognitive impairment, intending to promote cognitive stimulation, using PMT methods to build a rehabilitation nursing plan. Relying on older adults care institutions, older adults with mild cognitive impairment in a certain period were divided into a control group (CG) and an experimental group (EG). Older adults will be engaged in a 12-week PMT rehabilitation nursing plan involving relaxation and breathing exercises, face exercises, hand exercises, and mind exercises to promote cognitive health. SPSS 28.0 software was used to analyze data. The comparison of scores of various scales are based on paired t-test statistical methods. The P value \<0.05 will be considered to indicate statistically significant with 95% confidence interval (CI). The rehabilitation effect of the two groups was evaluated according to cognitive assessments (Montreal Cognitive Assessment, MoCA), psychological assessment (Positive and Negative Syndrome Scale, PANSS), and emotional assessment (Hamilton Depression Rating Scale, HAMD-17; Hamilton Anxiety Rating Scale, HAMA-14) . The expected findings of this study may be useful for cognitive rehabilitation plans for the elderly in care institutions, rehabilitation hospitals, communities, and families.

Digital STEADI Efficacy

The aging of the U.S. population, combined with health care workforce shortages and insufficient access to effective fall prevention and exercise programs, has contributed to a high burden of fall-related injuries in older adults, especially in those with Mild Cognitive Impairment (MCI), a precursor of Alzheimer's dementia (AD) and related dementias (ADRD). There is an urgent need for scalable, evidence-based interventions that can be delivered efficiently in the home setting. This study aims to evaluate the efficacy and impact of a comprehensive digital fall prevention program (Digital STEADI) delivered through a technology platform with two conversational agents that leverage generative artificial intelligence (gen-AI) with human oversight to increase program access, enhance adherence to clinical fall prevention protocols and best practices, and reduce fall risk among community-dwelling older adults.

To Evaluate the Safety and Efficacy of RP902 Tablets

The purpose of the study is to evaluate the preliminary efficacy of RP902 Tablets in participants with Alzheimer's disease (AD)-derived mild cognitive impairment (MCI) and provide a design basis for the Phase III study. This Phase II study plans to enroll 360 participants and will be conducted at approximately 50 sites in China. The study consists of a Screening Period (up to 4 weeks) and a double-blind treatment period (48 weeks). After completing the 48-week double-blind treatment period, participants may choose to continue into an extension treatment period (96 weeks) or undergo safety follow-up (4 weeks after the last dose).