Clinical Research Directory

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.

Wearable Sensor for Early Detection and Monitoring of Cognitive Decline

This observational study will enroll approximately 100 participants evenly split by cognitive status (Cognitively Impaired vs Non-Cognitively Impaired), and involves four clinic visits over one year (at baseline, 3, 6, and 12 months), each followed by 7 days of remote monitoring to assess the long-term feasibility of PAMSys+ (Physical Activity Monitoring System).

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.

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.

The Role of METhanogens in the PROgression Of Parkinson's Disease and Related Neurological Conditions

Gut problems, such as constipation, can have an important impact on quality of life of people who have them, and have been associated with higher risk of developing neurological diseases such as Parkinson's or Alzheimer's disease. Recent studies suggest that gut problems may also have implications for the progression of these diseases, as constipation is a risk factor for faster Parkinson's and Alzheimer's progression. However, how constipation and brain diseases are linked is unknown. Previous research has suggested that gut changes may lead to inflammation, which could play a role in accelerating the progression of both movement and memory problems in Parkinson's and memory and thinking problems in people with cognitive impairment. Methane is a gas that is naturally produced by microorganisms in the gut. Levels of methane can be measured using a simple breath test. Higher methane levels in the breath are thought to be more common in people with Parkinson's disease (PwP) when compared to people without Parkinson's (healthy controls) and have been associated with gut symptoms, particularly constipation, as well as worse movement problems in PwP, although they are less understood in conditions that affect memory and thinking (like dementia or mild cognitive impairment). The investigators want to better understand the changes in the gut of PwP and people with cognitive impairment (e.g. mild cognitive impairment or dementia). They will compare breath methane levels in PwP, people with cognitive impairment, people with REM Sleep Behaviour Disorder (a sleep condition linked to a higher risk of developing Parkinson's) and healthy participants. Participants will be followed-up over time to assess how methane levels are linked to changes in the blood and the stools, gut function, and clinical symptoms. This study has 2 components: Component 1: observational study, where the study investigators will follow 200 participants over 2 visits, 18 months apart. The study will recruit 4 groups of people: 50 people with Parkinson's disease, 50 people at high risk of developing Parkinson's disease (people with REM Sleep behaviour disorder), 50 people with other conditions affecting cognition (e.g. dementia, mild cognitive impairment), and 50 healthy controls. Component 2: study with 15 people with Parkinson's, who produce high methane levels, to test whether a probiotic (Lactobacillus reuteri) affects how much methane is produced.

AI-CONECT: A Conversational AI for Early Dementia Prevention in Socially-Isolated Older Adults

This randomized controlled trial examines the mechanisms of conversational AI-based interventions for early dementia prevention in socially isolated older adults.

Mild Cognitive Impairment and Neuromodulation

This is a parallel, sham-controlled design of low-intensity focused ultrasound in patients with mild cognitive impairment (MCI). The study will evaluate safety, tolerability, and effects on cognitive function.

Comparative Effects of Integrated Versus Sequential Approaches to Dual-Task Training in Elderly With Mild to Moderate Cognitive Impairment

Mild and Moderate cognitive impairment is a condition characterized by a noticeable decline in cognitive abilities, including memory and thinking skills, which is greater than expected for an individual's age but does not significantly interfere with daily life. Early intervention is essential to prevent further cognitive decline and progression to dementia. Dual-task training has emerged as an effective rehabilitation approach that combines cognitive and motor tasks to enhance neuroplasticity and improve both physical and cognitive performance. This study is designed to investigate the effectiveness of dual-task training compared to conventional therapy in individuals with mild cognitive impairment. Participants meeting the inclusion criteria will be recruited and randomly allocated into intervention and control groups. The intervention group will receive structured dual-task training, which may include activities such as walking while performing cognitive tasks (e.g., counting, word recall), balance exercises combined with mental tasks, and functional activities requiring divided attention. The control group will receive standard rehabilitation or single-task training. The intervention will be conducted over a specified duration (e.g., several weeks), with sessions held multiple times per week. Outcome measures will be assessed at baseline and after completion of the intervention. The primary outcome will be cognitive function measured using the Mini-Mental State Examination (MMSE). Secondary outcomes may include balance, mobility, and functional performance. Data will be analyzed to determine the effectiveness of dual-task training in improving cognitive and functional outcomes. The results of this study may contribute to evidence-based rehabilitation practices and support the use of dual-task interventions in clinical settings.

The "Let's Talk Tech" Tool to Support Decision Making About Technology Use

The goal of this research is to educate people about different technologies to support care at home when someone is experiencing memory difficulties. "Let's Talk Tech" is a new tool to educate people about technologies commonly used to support care and monitor safety, and help families talk about their feelings about them to understand each other's perspectives. The goal of this clinical trial is to learn if "Let's Talk Tech" helps people feel more prepared to make decisions about technologies. Researchers will compare Let's Talk Tech to usual care (no intervention) to see if Let's Talk Tech increases peoples' preparedness and confidence to make decisions about technologies. All participants will: * Use the Let's Talk Tech web application together with their study partner that takes up to an hour or do nothing. * Complete two surveys. The second survey will be taken within 2 weeks of the first. One participant in each pair will also take a 3rd short survey 3 months after the first.

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.

A Clinical Study Evaluating the Diagnostic Performance and Safety of PET for the Deposition of Aβ Plaques in the Brain of Participants With Normal Cognitive Function, MCI and AD Using [18F]Fluorbetazine Injection

A multicenter phase III clinical study evaluating the diagnostic performance and safety of PET for the deposition of Aβ plaques in the brain of participants with normal cognitive function, MCI and AD using \[18F\]Fluorbetazine injection.

Safety Assessment of H2 Inhalation in Patients With Mild Cognitive Impairment

An open-label, one-arm, single-center clinical study tested safety and efficacy of one hour daily dosage of H2 gas in a form of inhalation. Dosage is administered during morning hours every working day according to detailed instructions to study participants. Primary objective: To verify the safety of hydrogen gas inhalation on a sample of patients with mild cognitive impairment (according to the objective opinion of the physician) and diagnosed mild to moderate form of dementia, as well as to verify cognitive abilities via tests from prof. MUDr. Aleš Bartoš, Ph.D. - ALBA (Amnesia Light and Brief Assessment) and POBAV (Naming of pictures and their equipment). Secondary objective: To assess the effect on specific health indicators (e.g. inflammation, antioxidant capacity, metabolism) by blood sampling as well as blood pressure/pulse measurement and BMI. Primary endpoint: Inhalation Safety, Questionnaire - Subjective Assessment (ALBA and POBAV). Secondary endpoints: Biochemical indicators (e.g. inflammation, antioxidant status), blood analysis and BP/Pulse + BMI. Study population: 50-80 years old participants with mild cognitive declin in overall good health condition. Inclusion criteria: * patients diagnosed with mild cognitive impairment (MCI) with an overall good health condition * generally good health, with the ability to perform daily * activities independently (modified Rankin score 0-2, Barthel index minimum 70 points) * age between 50 and 80 years, ensuring inclusion of individuals within the typical risk range for cognitive decline * a reliable study partner or caregiver who can provide accurate information about the participant's cognitive and functional abilities throughout the study * stable medical condition, without major fluctuations in health status that could interfere with cognitive assessments * signed informed consent, ensuring that participants understand the study protocol and potential risks Exclusion criteria: * pregnancy or lactation, as the safety of hydrogen inhalation therapy in these populations has not been established * use of medications or investigational treatments that could significantly affect cognitive function or interfere with study outcomes * history of severe psychiatric disorders such as major depression, bipolar disorder, or schizophrenia, which may independently influence cognitive performance * history of cerebrovascular events, including recent stroke or transient ischemic attack, which may confound cognitive outcomes * severe cardiovascular diseases, including uncontrolled hypertension, recent myocardial infarction, or heart failure, that could pose additional risks during the study * chronic kidney disease (stage 3 or higher), as impaired renal function may alter systemic metabolism and affect the study's findings * significant respiratory disorders, such as severe chronic obstructive pulmonary disease (COPD) or restrictive lung diseases, that could impact the safety of hydrogen inhalation * known hypersensitivity or allergic reactions to materials used in the hydrogen delivery system, such as nasal cannulas or facial masks * recent participation in another clinical trial within the past 90 days, to prevent potential interactions and ensure unbiased study results Duration of the study for each participant: 24 weeks (12 weeks of hydrogen inhalation + 12 weeks withou hydrogen inhalation) This pilot study is not designed for formal hypothesis testing; its purpose is to gather descriptive safety data and estimate effect sizes for future research. We will enroll 30 participants to gather enough information on safety, tolerability, and feasibility. The primary analysis will concentrate on the frequency and severity of adverse events (AEs/SAEs) and ALBA + POBAV scores to evaluate cognitive changes. Descriptive statistics will summarize adverse events, vital signs, and lab results. In the secondary analysis, we will assess variations in biochemical markers (inflammation, antioxidant capacity, metabolism) and physiological metrics (blood pressure, pulse, BMI) using paired t-tests or Wilcoxon signed-rank tests, depending on how the data is distributed. Any missing safety data will be conservatively imputed, and multiple imputation techniques will be utilized for efficacy measurements. While there is no formal interim analysis planned, continuous safety monitoring will be carried out. Results will be shared through summary statistics, tables, and appropriate graphical representations, offering preliminary insights into the feasibility and potential advantages of molecular hydrogen inhalation therapy.

A Study To Assess The Feasibility Of Indivi Mobile Application In Monitoring Cognitive Performance In Aging Population

The goal of this observational study is to evaluate the functionality and usability of Indivi mobile application-based cognitive activities in people with mild cognitive impairment/mild Alzheimer's disease (PwMCI/AD) and healthy controls (HC). This application uses a dynamic difficulty adjustment (DDA) system that customizes the level of the cognitive activities to each user. The main questions it aims to answer are: * Does the DDA system reach a stable difficulty level at the same rate for both PwMCI/AD and HC? * Is the stable difficulty level reached by the DDA system different for PwMCI/AD compared to HC? Researchers will also compare cognitive activities results and other aspects of the mobile application's performance to see if the application can validly distinguish between the two groups. Participants will use the Indivi mobile application, with its embedded DDA system, for a 6-week period.

Alzheimer's Disease Research Center (ADRC) PET Component Study

The purpose of this study is to further engage and characterize Alzheimer's Disease Research Center (ADRC) participants through additional research opportunities, particularly PET imaging. Amyloid and Tau PET imaging will be collected in 24 participants per year, for a total of 120 participants over five years. All participants will be followed longitudinally, including through potential transitions from normal aging to mild cognitive impairment (MCI) and Alzheimer's disease and related dementias (ADRD).

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.

Safety Of Nrtis for Alzheimer's Therapeutic Advancement in Singapore Study

Recent studies have identified an association between Alzheimer's Disease (AD) and an expansion of DNA content in the brain (prefrontal cortex). This additional DNA content appears to be derived from reverse transcriptase (RT) activity that incorporates genomic cDNAs (gencDNAs) into chromosomes, resulting in multiple copies of full length and shorter cDNAs involving many genes - including the causal AD gene amyloid precursor protein (APP). Accumulation of these APP gencDNAs is associated with AD. This identifies RT as a promising therapeutic target for the attenuation of AD progression through existing reverse transcriptase inhibitors (RTi's) that have been widely used for treating HIV and hepatitis B. Since this class of drugs has been in the clinic for over 3 decades, there are significant data supporting their post-approval safety for long-term use. However, this has not been specifically addressed in the target population - patients with mild cognitive impairment (MCI), particularly women - who are underrepresented in HIV datasets. This proposed Phase I safety trial will perform a Special Population Study in a cohort of MCI patients who may benefit from the intervention. This study aims to (1) evaluate the safety and tolerability of standard dose FTC or Descovy for 3 months in MCI patients; (2) as secondary aims, collect preliminary data on clinical effects of standard dose FTC or Descovy compared to placebo for 3 months on cogntiive function in MCI patients; and (3) collect preliminary data on clinical effects of standard dose FTC or Descovy compared with placebo on AD-associated inflammatory markers. Participants will be randomized into either Descovy or FTC arms in equal numbers, and receive either active drug or placebo. Participants will orally ingest 1 capsule or tablet (depending on drug arm) daily for the 3 month participation period. The investigators hypothesise that MCI are not at increased risk of adverse effects due to administration of standard dose FTC or Descovy.

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.

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.

Gamma tACS to Improve Cognitive Function in Mild Cognitive Impairment

Mild cognitive impairment (MCI) is a decline in memory and thinking that exceeds normal aging but does not substantially disrupt daily life, and it raises the risk of developing dementia. Effective treatments for its cognitive difficulties are few. This study tests whether transcranial alternating current stimulation (tACS), a non-invasive method that delivers a weak oscillating electrical current through scalp electrodes, can improve thinking and memory in older women with MCI. The current oscillates at 80 Hz, a frequency in the gamma range, because gamma brain rhythms support memory and attention and are disrupted in MCI. Thirty older women with MCI are randomly assigned to receive either active 80 Hz tACS or sham (placebo) stimulation. Participants and the person delivering the stimulation do not know the group assignment. Both groups complete the same cognitive tests before and after the sessions, measuring overall cognitive status, planning, visuospatial working memory, and reaction speed. The aim is to determine whether active 80 Hz tACS improves cognitive performance more than sham stimulation.

Innovative Cognitive Impairment Case Finding and Engagement for Diverse Participation in Alzheimer's Disease Care, Treatment, And Research

Recent studies have highlighted the potential use of electronic health record (EHR) data for scalable and less biased identification of people who may have or be at risk of developing MCI or ADRD at the population level.8,9 Using data from the EHR in advance of PC visits can systematically identify patients with undetected MCI and ADRD. At Indiana University (IU), researchers developed a Passive Digital Marker (PDM) to enable early detection of ADRD with an 80% accuracy for one-year and three-year prediction horizons.8,9 Despite the accuracy of the PDM, the feasibility, acceptability, and overall effectiveness of its use for early detection of ADRD in PC remains unclear. Building on this innovative tool and the ongoing engagement in IUH PC for early detection of ADRD, we propose a project to test the acceptability and feasibility of implementing the PDM in IUH PC to identify people with and at risk of MCI and ADRD and measure if we can increase patient engagement in research and evidence-based follow-up care with the IUH Brain Health Navigator (BHN). The BHN, is primary care based registered nurse with special training to conduct additional assessments of patients following a positive ADRD screen to identify possible underlying causes of cognitive impairment and assist the PCP to facilitate the patient's next steps for diagnostic assessment.

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).

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

cMIND AI Web Tool Usability Study (Hong Kong)

This study is testing a new web-based tool that uses artificial intelligence (AI) to help older adults in Hong Kong check how healthy their Cantonese-style meals are for brain health. The tool is based on the cMIND diet, a Chinese-adapted version of a known healthy eating pattern that may support memory and thinking skills. Participants will use the web app to take photos of their usual meals for at least 10 days over two weeks. The AI will automatically identify ingredients and give a score showing how well the meal follows the cMIND diet. The study will also ask participants to complete a short questionnaire and a brief interview to find out how easy and useful the tool is for older adults. The purpose of this small study is to see whether the AI tool is user-friendly and acceptable for older people. Results will help improve the tool for future use to support healthy ageing and brain health.

Cognitive Training and Neuroplasticity in Mild Cognitive Impairment: COGIT-2 Trial

Effective, clinically meaningful treatments are lacking for patients with mild cognitive impairment (MCI), which is associated with increased risk of transition to dementia. Cognitive training represents an important therapeutic strategy. In a previous study, crossword puzzles were found to be superior to computerized cognitive training on the primary cognitive outcome and function with decreased brain atrophy. Building on these findings, this study will evaluate and compare the impact of high dose crosswords (4 puzzles per week) to low dose crosswords (1 puzzle per week) and a health education control group on the cognition and function of participants.