Clinical Research Directory

Percepta for Cognitive Optimization

This Phase 1, randomized, double-blind, placebo-controlled trial evaluates the cognitive and neurophysiological effects of a dietary supplement containing cat's claw (Uncaria tomentosa) bark extract and oolong tea extract, in adults aged 40-85 with self-reported mild cognitive impairment (MCI). The study employs a decentralized design leveraging remote monitoring technologies. Participants will self-administer the study supplement or a matched placebo daily for 6 months. The primary outcome is cognitive performance assessed by digital Montreal Cognitive Assessment (MoCA) at baseline, Month 3, and Month 6. Secondary outcomes include objective sleep and autonomic metrics from Oura Ring wearables (heart rate variability, sleep architecture) and self-reported brain health using the Brain Health Index. An exploratory sub-study will measure plasma biomarkers of neurodegeneration (pTau-217) at baseline and Month 6 in a subset of participants to explore potential mechanisms of action. The study aims to provide preliminary evidence for Percepta's efficacy in improving cognitive function and supporting brain health in individuals with MCI, while evaluating safety and biological plausibility through mechanistic biomarkers.

Crownlands Observing Progression With Neurons Study

The CROWN-I Study is an observational study to learn about molecular features of Alzheimer's disease (AD) and mild cognitive impairment (MCI). The primary objective is to identify the molecular and genetic modules that differentiate patient subtypes and predict progression of AD. Participants will visit clinical sites to donate samples multiple times and perform virtual and in-person clinical assessments.

Validation of Population Characteristics and Dosage Prescriptions for Cognitive Function Intervention Benefits of Different Doses of Tai Chi in Elderly Patients With Mild Cognitive Impairment: A Real-World Cross-Sectional Study

This is a companion real-world external validation study of two pre-registered parent randomized controlled trials (RCTs, protocol IDs: FujianUTCM-1 and FujianUTCM-2). We aim to validate the generalizability and clinical applicability of a pre-developed machine learning prediction model (for Tai Chi intervention cognitive benefit population characteristics and individualized dose prescription) in a real-world community-dwelling population.

Designing a Spatial Navigation Intervention Protocol Informed by Region-specific Brain Activation for Mild Cognitive Impairment

The goal of this one-arm clinical trial is to determine whether participants with mild cognitive impairment (MCI) can successfully navigate a virtual reality (VR) maze. The VR maze is designed as a training tool aimed at improving participants' spatial navigation abilities. Main Aims: 1. To determine whether at least 70% of older adults enrolled in the study can complete twenty-four 50-minute training sessions over a 4-month period. 2. To assess whether combining virtual reality with EEG recordings can be used to measure brain activation and changes in brain activation associated with spatial navigation learning. Participants will: 1. Walk in an open, unobstructed space while wearing VR goggles. 2. Explore up to fifty different virtual mazes in sequence and attempt to find their way through each one.

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

Optimising Exercise to Improve Physical and Cognitive Frailty in Mild Cognitive Impairment

This investigational research aims to understand the mechanism of delaying the progression of dementia through different types of exercise. Exercise plays a protective role by attenuating the progression of cognitive impairments in mild cognitive impairment (MCI), an early and reversible stage of dementia. However, how different types of exercise induce changes in physical frailty and cognitive function is understudied. The participants will be randomized to receive an exercise intervention program (cycling or strength training) for 12 weeks or a control group. The participants will be asked to perform certain cognitive and physical assessments at the start of the study, at the end of 12 weeks of exercise intervention, and 4 weeks after the end of the intervention. Below is the list of the assessments: * Patient Health Questionnaire-9 (PHQ-9) * World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0-12) * Self-report on sociodemographic characteristics, ethnicity, socioeconomic status, educational level, smoking status, alcohol intake, comorbidities, chronic medications, social activities, history of falls * body height, weight and fat percentage, heart rate, blood pressure, Dual-Energy X-Ray Absorptiometry (DEXA) scan: measurements to evaluate overall physical characteristics * handgrip strength: to evaluate musculoskeletal function * Stroop test: to evaluate information processing speed and executive cognitive control * n-back task: to evaluate working memory and executive function * Timed Up and Go (TUG) test: to measure balance * single-task gait: to measure walking ability * double-task gait: to measure walking stability and attention During Stroop test, n-back task, Timed Up and Go (TUG) test, single-task gait and double-task gait, the participants will be equipped with a mobile functional near-infrared spectroscopy (fNIRS) device over their forehead. This device is used to detect changes in blood flow in the front area of the brain. Their participation will last approximately 18 weeks (2 weeks of familiarization and assessment, 12 weeks of exercise intervention, and 4 weeks of follow-up).

Computerized Cognitive Training in Healthy Older Adults and Mild Cognitive Impairment

The overall objective of this study is to assess the effect of an adaptive computerized cognitive training program for executive functions (CogniFit platform) on improving these functions in older adults, both healthy and with mild cognitive impairment (MCI), as well as to examine the potential transfer effects of this training on memory. Additionally, determine the impact of the intervention on the emotional symptoms, behavioral disorders, or quality of life of the participants.

Expanding Access to Cognitive Health Biomarker Testing at Home

The goal of this observational study is to learn whether at-home blood biomarker testing for Alzheimer's disease risk is feasible and acceptable in older adults with cognitive concerns. The main questions it aims to answer are: * Can older adults with subjective cognitive concerns or possible mild cognitive impairment successfully complete a fully remote workflow that includes at-home capillary blood collection, overnight shipping, central laboratory analysis of phosphorylated tau-217 (p-tau217), and remote disclosure of results by a neurologist? * Is this remote at-home p-tau217 testing workflow acceptable to participants? Participants are adults aged 65 and older who participated in the SHUTi MIND parent study (NCT05565833) and report subjective cognitive concerns or screen positive for possible mild cognitive impairment. Participants will collect a small capillary blood sample at home, return the sample to a central laboratory by overnight shipping for p-tau217 analysis, receive their result during a remote visit with a board-certified neurologist, and complete online surveys at baseline, after results disclosure, and 6 months post-disclosure.

Creatine and Resistance Training in Older Adults With Mild Cognitive Impairment

The goal of this 26-week trial is to learn if creatine supplementation and resistance training (i.e., weightlifting; exercise that increases muscle mass), alone and together, impact cognition, brain health, and physical function in older adults with mild cognitive impairment. Previous studies have shown that resistance training improves cognition and brain health in older adults. Creatine is naturally occurring in the human body and is known to decline with age. Studies have shown that creatine increases muscle mass and bone density in older adults when supplemented. Some research has suggested that creatine may also improve cognition and brain health. However, little is known about how creatine supplementation affects the aging brain and body alone and when combined with resistance training, especially in those with known cognitive impairment. In this study, participants will be randomly assigned to one of four groups: 1) creatine and resistance training, 2) placebo and resistance training, 3) creatine and active control (balance and tone classes), or 4) placebo and active control. Participants in the creatine groups will take creatine every day during the study. Participants in the placebo groups will take a look-alike substance that contains no drug every day during the study. Participants in the resistance training groups will attend three 60-minute classes per week that target each major muscle group and will increase in difficulty during the study. Participants in the active control group will attend three 60-minute classes per week that will consist of balance, stretching, and range of motion exercises. This group accounts for variables such as physical training received by traveling to the training centres, social interaction, and changes in lifestyle secondary to study participation. Researchers will collect information before and after the 26 weeks to see if creatine supplementation and/or resistance training have any effects on cognition, brain health, and/or physical function. The investigators suspect that both creatine supplementation and resistance training will improve cognition, brain health, and physical function alone. However, it is thought that the combination of creatine supplementation and resistance training will improve cognition, brain health, and physical function more.

Instant Message-delivered Personalised Acceptance and Commitment Therapy (IMPACT) for Neuropsychiatric Symptoms in Persons With Mild Cognitive Impairment

This study aims to develop an automated instant message-delivered intervention (i.e., EMI) for people with mild cognitive impairment to reduce their NPS, and to investigate the feasibility and effectiveness of the intervention.

The Combined Multicomponent Intervention Specifically in Rural Community Older Adults at High Risk for Mild Cognition Impairment

This project aims to test whether a combined multicomponent (CM) program - including health education, cognitive training, and traditional Chinese exercises - is feasible and effective for rural older adults who are at high risk of mild cognitive impairment (MCI). The program is designed to help maintain or improve cognitive function and overall well-being.

Predictors Of Cognitive Decline Using Digital Devices

The overall aim of this study is to find out if people with cognitive difficulties will wear and use different types of digital technology, and if they will allow data from that technology and their clinical profile to be collected. Participants will be patients in Essex Memory clinic and their partners/carers. The digital technology used will include a smartwatch, a sleep headband and two smartphone applications, which have been selected as part of the Early Detection of Neurodegenerative Disease (EDoN) initiative. The investigators will also investigate how the digital data can be analyzed together with routinely captured clinical data using machine learning models, a complex type of statistical analysis. The aim of the wider EDoN initiative is to combine digital and clinical data to develop machine learning models which can predict individuals' risk of developing dementia decades before the onset of symptoms.

Safety And Tolerability Of Gamma Glutamylcysteine (GGC) Oral Supplementation In MCI Patients

The goal of this study is to evaluate the safety and tolerability of Gamma Glutamylcysteine (GGC) supplement at different doses (400mg/day or 800mg/day or 1200mg/day) when administered orally to patients with MCI over 3 months. This study is designed to generate preliminary clinical safety data to inform the feasibility and design of larger controlled trials.

Speech-Based Artificial Intelligence for Detection of Dementia in Danish Patients (DetectAI)

The goal of this observational study is to learn if an artificial intelligence (AI)-based speech analysis tool can identify which patients with memory problems need specialist evaluation at a memory clinic. The main questions it aims to answer are: Can the AI model accurately distinguish between patients who need referral to a memory clinic (those with dementia or Mild Cognitive Impairment) and patients who don't (those with normal cognition or memory problems from other causes like depression)? Which speech patterns and cognitive test features are most useful for making this distinction? Researchers will compare speech recordings and cognitive test results from patients diagnosed with dementia or MCI to those from patients with normal cognition or non-neurodegenerative cognitive impairment to see if the AI model can reliably predict who needs specialist dementia care. Participants will: Complete standard cognitive tests at the memory clinic Perform structured speech tasks while being audio-recorded Receive their usual clinical evaluation and diagnosis from memory clinic specialists The results of this study will help develop a tool that can assist doctors in making faster, more accurate decisions about which patients need specialist dementia evaluation, potentially leading to earlier diagnosis and better patient outcomes.

Ketogenic Diet to Reduce Osteoarthritis Pain in MCI

Osteoarthritis and mild cognitive impairment are common conditions that share underlying biological processes related to metabolism and inflammation. This study will examine whether a well-formulated ketogenic diet influences pain, physical function, and cognitive outcomes in adults with osteoarthritis and mild cognitive impairment. Participants will follow a supervised ketogenic dietary intervention, with assessments conducted before and after the intervention to evaluate changes in symptoms and related biological markers. The goal of this study is to better understand shared mechanisms between joint pain and cognitive health and to explore whether a ketogenic dietary approach may support symptom management in these populations.

e-ALIGN: A Patient Portal-based Intervention to Align Medications With What Matters Most

The overarching goal of this study is to pilot an intervention in which older adults with mild cognitive impairment and dementia and the older adult's care partners are identified in primary care and provided with educational materials through the patient portal to engage the participant in deprescribing. The multicomponent intervention, e-Align, includes delivery of educational information through the patient portal, and a pharmacist-led intervention to align medications with patient and care partner goals and reduce use of central nervous system (CNS) potentially inappropriate medicines (PIM). This work will establish the preliminary data, methods, and partnerships to undertake a multisite embedded pragmatic clinical trial. The resulting triadic-based behavioral intervention will promote patient and care partner engagement, and foster care that aligns with patients' values, and promote improved health and well-being outcomes for people with cognitive impairment and the patient's care partners through deprescribing.

Telemedicine Self-examination of Speech and Memory for Rapid Detection of Cognitive Impairments Using Machine Learning Methods

Early cognitive disorders diagnosis is becoming increasingly important due to population aging. The most common causes include Alzheimer's disease and frontotemporal dementia. These diseases are also manifested by changes in speech. NLP allows us to identify and classify these changes. The project aims to develop a web application for self-assessment and automated detection of cognitive disorders from speech. The application will have a form of a dialogue system using machine learning methods. The novelty of this approach is the possibility of an efficient self-assessment of a wide spectrum of the Czech population from their homes and an automated evaluation of test results. Early detection can be followed by a more detailed diagnosis and adequate treatment.

Genetic Studies of Early-onset Dementia

The aim of this study is to identify genetic factors that contribute to risk and progression of early-onset dementia (loss of memory function before the age of 70 years) across all ethnic groups, including Alzheimer's Disease, mild cognitive impairment and other dementias.

Personalized Digital Training for COGnitive FITness in Mild Cognitive Impairment

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.

Impacts of Kebbi Robot Intervention for Older Adults With Mild Dementia

The goal of this clinical trial is to examine the immediate and sustained effects of an intensive Kebbi robot intervention on cognitive functions, heart rate variability (HRV), and psychological changes for older adults with mild dementia in long-term care (LTC). The main questions it aims to answer are: * Are intensive Kebbi robot interventions effective in improving cognitive functions, HRV, and psychological changes for older adults with mild dementia in LTC? * What are the participants\' experiences and perceptions after intensive Kebbi robot interventions? Researchers will compare intensive Kebbi robot interventions to a control group (receiving usual activity) to see if they are effective in improving cognitive functions, HRV, and psychological changes in older adults with mild dementia in LTC. Participants will: * Participants in the intensive Kebbi robot interventions will receive 30 minutes, thrice weekly, for 12 weeks. Participants in the control group will receive the usual activity. * The outcome measures will be conducted at three time points: before the intervention (T0), immediately after the end of the intervention (T1), and one month after the end of the intervention (T2). * Outcome measurements include the cognitive outcomes: Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Finger Tapping Test (FTT); heart rate variability (HRV); psychological changes: the Geriatric depression scale-short form (GDS-SF), the UCLA Loneliness Scale Version 3 (UCLA- Version 3), and the Friendship scale.

Multicomponent Intervention to Improve Cognitive Abilities in Older Adults With Mild Cognitive Impairment

The research aims to investigate the effectiveness of a new short-term multicomponent intervention to promote the bio-psycho-social-spiritual health of older adults with MCI to improve their cognitive abilities. In this study, the multicomponent intervention consists of healthy lifestyle psychoeducation and cognitive stimulation. This study is a double-blind, clustered, randomized, controlled, four-arm parallel group study. 200 eligible older adults with MCI are openly recruited into activity groups in local elderly centres. The activity groups are randomly allocated to three intervention groups (i.e., multicomponent intervention, cognitive stimulation and lifestyle psychoeducation) and a control group in a 1:1:1:1 ratio. The participants with MCI are blinded on group allocation and kept uninformed which type of intervention they are receiving. An investigator, blinded to group allocation and intervention, assess outcomes using standardized assessment tools before and after the intervention and after 3 months.

A Multifocal tDCS-EEG Protocol for Improving Symptoms of Mild Cognitive Impairment and Early Dementia

The goal of this clinical trial is to learn if an integrated protocol using multifocal non invasive brain stimulation and brain recording combined with cognitive training is effective in treating cognitive and affective symptomatology in patients with mild cognitive impairment and early stages of dementia. The main questions it aims to answer are: * Does multifocal non-invasive brain stimulation reduce cognitive and affective symptoms in patients with mild cognitive impairment and early stages of dementia? * Do some specific factors, such as education and cognitive reserve, affect the extent of the possible outcomes achievable from the intervention? * Do electrophysiological measures contribute identifying responders and non-responders to the treatment? Researchers will compare real non-invasive brain stimulation to a placebo stimulation (reproducing the same feeling of stimulation without actually stimulating the brain) combined with cognitive rehabilitation on general cognition measures and depression symptoms. Participants will * Undergo two treatment cycles (real stimulation or placebo over frontal and temporal ares of the left hemisphere) combined with cognitive training twice a week for two months. * Complete neuropsychological evaluations before the first rehabilitation cycle and at the end of each rehabilitation cycle. Caregivers will provide information on functional daily living activities for their relatives.

Culturally Familiar Nostalgic VR Cognitive Training for Older Adults

This randomized controlled trial investigates the effects of a nostalgia-based cognitive training intervention delivered via Virtual Reality (VR) on emotional well-being and cognitive functioning among community-dwelling older adults (≥65 years) in northern Taiwan, specifically targeting those with mild cognitive impairment (MCI) or mild dementia. The study, conducted at National Taiwan Normal University, aims to assess whether engaging older adults in nostalgic VR experiences can enhance nostalgia proneness, life satisfaction, and psychological well-being, while also reducing depressive symptoms and improving cognitive functions. Participants who meet inclusion criteria (aged 65+, capable of communicating in Mandarin or Taiwanese, without severe psychiatric conditions, with sufficient vision/hearing) will be randomly assigned to either the experimental group receiving the "Brain Health Nostalgic VR Program" or a control group engaged in routine weekly activities. Each session, scheduled twice weekly, spans 25-35 minutes in total, including setup, support, and breaks, while the actual VR usage time is 15-25 minutes depending on individual tolerance. Research staff will provide close support and safety monitoring during all sessions. Pre- and post-intervention outcomes will be measured using standardized assessments: Southampton Nostalgia Scale (SNS), Short-Form Life Satisfaction Index (LSI-SF), Geriatric Depression Scale (GDS-15), Short-Form Chinese version of Ryff's Psychological Well-being Scale (PWB-18), and the Montreal Cognitive Assessment Taiwan Version (MoCA-T). The study emphasizes participant safety and data confidentiality throughout its duration. Findings aim to demonstrate VR's potential as a non-invasive, preventive strategy for cognitive decline and mental health enhancement among older populations.

Exploring the Impact of Dementia Prevention Programs Using Robots as Intervention Tools on Community Elderly

The purpose of this study is to intervene in the cognitive functions of the community elderly through the "Robot Dementia Prevention Course" training. It is expected that through the eight-week course design activities, the cognitive functions, social activities, emotional management (such as alleviating depression), well-being, reduce loneliness and can be achieved, thereby preventing or delaying cognitive decline. This study is a quasi-experimental design. It adopts pre-test and post-test methods for the experimental group and the control group. Before the intervention of the "Robotic Dementia Prevention Course", the community elderly were given a pre-test. After receiving an 8-week course (two months), the first post-test will be conducted, and three months later, the second post-test (post-post-test) will be conducted to analyze the delay effect. The experimental group conducted a two-month "Robot Dementia Prevention Course" intervention. The research subjects were 40 people. Each group of 5 people was assigned a Kebbi robot. The course intervention was divided into 8 groups. The Kebbi robot mainly taught and communicated with the elderly interactively. There is a well-trained teaching assistant in the class to enhance the learning effect of the elderly. The two classes per week are about 2 hours long, with 50 minutes of course knowledge introduction, 10 minutes of rest, 50 minutes of interaction with Kebbi Artificial Intelligence-based board games, and 10 minutes of prize-based quizzes after class. They are held once a week, with a total of 8 weeks of courses (duration two months), classes were taken in the elderly's original care center or long-term care base; the control group did not receive any course intervention. Statistical methods were analyzed using SPSS version 23.0, and descriptive statistics, paired t tests, generalized estimating equations, etc. were used to test the changes before and after the intervention.