Clinical Research Directory

Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices

The goal of this clinical trial is to investigate motor responses in healthy subjects and patients with movement disorders, brain and spinal cord injury, neuromuscular diseases, or cardiovascular diseases. This study aims to evaluate the effectiveness of traditional physical activities combined with innovative interventions such as cryotherapy, ultrasound therapy, laser therapy, transcranial magnetic stimulation (TMS), and transcranial direct current stimulation (tDCS). It will also assess the impact of proprioceptive stimuli provided by either the immersive virtual reality (CAREN), or visuo-cognitive-motor enhancement (S.V.T.A.), and music therapy. The main questions it aims to answer are: How do these interventions affect motor activities and their functional recovery? What are the temporal and spatial changes in activation sequences related to motor learning and maintenance? When there is a comparison group: Researchers will compare outcomes between different intervention arms (e.g., physical activity with advanced devices vs. traditional methods) to find out if the advanced interventions result in better motor control and functional recovery. Participants will: * Undergo various rehabilitation protocols including physical activity and advanced interventions. * Be assessed using different tool, such as fMRI, dtMRI, and NIRS to study in vivo neuroimaging and assess changes in brain function and connectivity.

A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease

The purpose of this study is to assess whether JNJ-64042056 affects the spread and build up of tau (a protein in brain) when compared with placebo, using brain scan (tau PET) to determine results from specific areas of the brain.

A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo in the treatment of psychosis in patients with AD.

A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease

The main purpose of this study is to evaluate the long-term effectiveness of donanemab plus usual care versus usual care alone in participants with early symptomatic AD. The study will employ a prospective, observational cohort design with participant management resembling real-world practice to the greatest extent possible via prospective assessments and linkage to historical and prospective electronic health records. The study will last about 273 weeks and may include up to 28 visits.

Does EVOO Induce Gene and Metabolic Changes in Healthy Subjects

Investigators' recent findings from the pilot clinical trial in MCI individuals demonstrated EVOO improved vascular function and memory. Yet, up to date, whether EVOO protects against AD in individuals with a family history of AD is unknown. Thus, in this study, the investigators will recruit healthy individuals with a family history of AD for participation. From eligible participants, blood samples for ApoE genotyping will be collected, followed by metabolomics, lipidomics, and transcriptomics analyses at baseline. Participants will be randomized into 2 groups (n=20 each); one group will receive EVOO daily (\~2 tablespoons, 30 ml) for 6 months, and the second group will not receive olive oil. Both group participants will receive educational information on brain health and how environmental factors such as lifestyle, diet, and exercise could impact brain health. After 6 months, another blood sample will be collected from the participants to evaluate the effect of EVOO on metabolites, lipids, and genes, and thus physiological pathways. The investigators will perform non-targeted and comprehensive metabolomics, lipidomics, and transcriptomics analyses. Examples of metabolites to be analyzed are antioxidative and anti-inflammatory metabolites, neurotransmission, mitochondrial, tryptophan, and purine metabolisms. Examples of lipidomics include sphingomyelins (SMs), cholesterol esters (ChEs), phosphatidylcholines (PCs), phosphatidylethanolamines (PIs), phosphatidylinositols (PIs), and triglycerides (TGs). Transcriptomics will be used to identify changes in mRNAs involved in different pathways contributing to AD, such as genes involved in inflammation and oxidative stress, in both ApoE-dependent and independent fashion.

The PorchLight Project

The proposed project is a fully embedded pragmatic trial (R01), following an R61 pilot collaboration with Lutheran Social Service of Minnesota (LSS-MN). For this project: a) the training program for Senior Companions that was developed in the R61 Phase will now be delivered as part of a routine onboarding process provided by LSS-MN to all senior support volunteers in half of their program regions across Minnesota; LSS-MN will offer the PorchLight Project program to all regions and volunteers in the state during the final months of the proposed NIA project, consistent with quality improvement approaches; and b) LSS-MN will administer regular surveys to volunteers, clients, and caregivers as part of ongoing tracking and quality improvement efforts. The University of Minnesota investigators will not collect data nor administer training, as these activities will be fully integrated into the workflow of LSS-MN. \[Note: Since it was learned that caregivers receiving services/affiliated with LSS-MN programming who receive surveys are for the most part not providing care to LSS-MN clients, as of fall 2024, UMN will no longer request and analyze data on LSS-MN caregivers.\] UNIVERSITY OF MINNESOTA INVOLVEMENT: The University of Minnesota and collaborating investigators outside of LSS-MN will only 1) assist in survey item selection, 2) randomize the LSS-MN regions for the initial phases of the real-world trial for evaluation purposes, 3) analyze the de-identified data shared by LSS-MN, and 4) disseminate the project results in scientific, practice, and policy outlets/contexts.

Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial

Our study intends to offer 'real world' evidence of a viable, sustainable means to mobilize primary care via a comprehensive strategy for detecting cognitive impairment and dementias, advancing next steps for referral, and participating in the care planning and management of affected patients and caregivers. We will conduct a clinic-randomized, pragmatic trial testing the effectiveness and fidelity of our NIH Toolbox-derived paradigm to improve early detection and management of cognitive impairment/dementia in primary care settings serving health disparate patient populations.

Tau PET Outcomes With Anti-amyloid Immunotherapies

This is an imaging study of patients with mild Alzheimer's disease receiving amyloid-targeting therapy and under the care of neurologists at Mayo Clinic in Rochester, MN.

The Gut - PRO Study

The purpose of this study is to assess the safety and feasibility of an oral probiotic supplement (PS) intervention in individuals with dementia or mild-cognitive impairment (MCI) due to Alzheimer's disease or at risk of dementia due to Alzheimer's disease (AD). 40 participants will be enrolled and can expect to be on study for up to 1 year.

Tricaprilin Phase 3 ALTER-AD (Alternative-Alzheimer Disease) Study

The purpose of this study is to evaluate the effects of tricaprilin (20 g twice a day) on cognition, global function, activities of daily living, resource utilisation, safety, and tolerability, in participants with mild to moderate AD dementia. This is a randomised, double-blind, placebo-controlled, parallel-group, multi-centre design in up to 535 participants.

Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Dementia

The purpose of this study is to investigate whether a blood pressure medication, spironolactone, can be tolerated by older African American adults that have memory and thinking problems, also called mild cognitive impairment (MCI). This study will also investigate the effect of spironolactone on memory and thinking abilities as measured by performance on cognitive tests, which are tests that measure memory and thinking skills. Participants will take spironolactone or a placebo for one year and will have 4 to 5 study visits during the study period.

OCT-Angiography and Adaptive Optics in Patients With Memory Impairment

Studies suggest an association between retinal abnormalities and NCD (Neuro Cognitive Disorders) whether they are linked to proven or prodromal Alzheimer's disease (aMCI : amnestic mild cognitive impairment), or to other neurodegenerative diseases such as frontotemporal dementia or Lewy body diseases. These retinal anomalies objectified by OCT-A (Optical coherence tomography angiography) and adaptive optics (AO) appear different depending on the pathologies and could therefore serve as markers in vivo of the pathophysiological processes underlying NCD. No study to date has studied the retina and its vessels in NCD using adaptive optics. In this pilot study, we are proposing a combination of two new ophthalmological imaging techniques (OCT-A and AO), which allow rapid in vivo analysis in a completely non-invasive way of the morphology of small vessels as well as architecture of the retina to better specify the retinal anomalies associated with NCD. We will compare the parameters in OCT-A and AO between patients with NCD and controls without NCD (with memory complaint or without) and will seek to determine if there are different profiles according to the causes of NCD.

A Study to Learn How Different Amounts of the Study Medicine Called PF-08161842 Are Tolerated and Act in the Body in Healthy and Older Adults

The purpose of this clinical study is to learn about the safety and effects of the study medicine (called PF-08161842) and how it is processed by the body. This is the first time PF-08161842 will be given to people. This study is seeking healthy adults: * 18 to 64 years of age or 65 to 85 years of age * Who are in generally good health * Who meet study conditions for body weight and body mass index (BMI) Participants will receive either PF-08161842 tablets or matching placebo tablets. Placebo tablets do not contain active medicine. In some study groups, participants will receive a single dose of study medicine. In other study groups, they will receive the study medicine for 14 days. The tablets will be taken by mouth at the study clinic. The investigators will compare the experiences of people receiving the study medicine with those of people who do not. This will help researchers determine if PF-08161842 is safe and how it affects the body. Participants will stay at the study clinic for several days so the study team can closely monitor their health. The study will include physical examinations, checks of blood pressure, heart rate, temperature, and breathing. It will also include blood and urine samples and heart tracing tests (ECGs). Researchers will assess how the body processes the study medicine. Some participants will also have lumbar punctures (spinal taps) to collect small samples of fluid from around the brain and spinal cord. The study team will monitor participants for any reactions throughout the study. For people receiving a single dose, the study will last for about 9 weeks. For those receiving multiple doses the study will last for about 11 weeks. This includes screening, study visits, clinic stay, and follow-up contact after the last dose.

A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease

The main purpose of this study is to evaluate the safety of LY3954068 in participants with early symptomatic Alzheimer's Disease (AD). The study will also investigate how much LY3954068 gets into the bloodstream and will test the effects of LY3954068 on markers of AD. The study will be comprised of two parts, A and B. Each enrolled participant in Part A will receive a single dose of LY3954068 or placebo (no active drug) given into the spinal fluid. Each participant in Part B will receive up to 4 doses of either LY3954068 or placebo administered into the spinal fluid. Participants may have the opportunity to join an optional bridging period to a separate potential study where participants would receive LY3954068. The study will last up to approximately 45 weeks for Part A, and 100 weeks for Part B, including the screening period.

A Study of NTRX-07 in Participants With Alzheimer's Disease

1. Study Overview NeuroTherapia Inc. is conducting a clinical study to explore the safety and effects of a new drug called NTRX- 07. This drug targets people with mild cognitive impairment (MCI) or mild to moderate Alzheimer's disease (AD). The study's primary focus is on safety and how the drug interacts with the body over a short-term period of 28 days. This research is important as it aims to find new ways to manage symptoms and slow the progression of AD. 2. Key Objectives Primary Objective: * To assess the safety and tolerability of NTRX-07 in patients with AD. * Safety and tolerability will be measured by monitoring any side effects or adverse events in participants during and after the treatment period. Secondary Objective: * To study how NTRX-07 is processed by the body, including how it is absorbed, distributed, metabolized, and eliminated. * This includes measuring the drug levels in the blood and cerebrospinal fluid (CSF) over time. 3. Study Design • Type of Study: o A randomized, double-masked, placebo-controlled study. "Randomized" means participants are randomly assigned to receive either the actual drug (NTRX-07) or a placebo (an inactive substance). "Double-masked" indicates that neither the participants nor the researchers know who receives the real drug or the placebo, reducing bias and ensuring objective results. • Participants: * 48 individuals with MCI or mild to moderate AD. • Treatment Groups: * Participants will be split into two groups: 24 will receive NTRX-07, and 24 will receive a placebo. • Duration: * The study will last up to 7-10 weeks for each participant, including a 28-day period during which they take the drug or placebo daily. 4. Study Procedures • Screening Period: * Before starting the treatment, participants will undergo a screening period of up to 45 days. During this time, they will have tests to confirm their eligibility, including physical exams, blood tests, cognitive assessments, and brain imaging (MRI). • Treatment Period (28 days): * Participants will take the study drug or placebo daily for 28 days. During this period, they will visit the study center for evaluations, including safety checks, cognitive tests, blood and CSF sampling, and EEG tests (to measure brain activity). • Follow-Up: * After the treatment period, participants will have a follow-up visit 7 days later for final safety assessments. 5. Safety Monitoring and Assessments * The study's primary focus is on safety. Researchers will monitor participants closely for any adverse events, such as side effects, throughout the study. * Safety assessments will include monitoring vital signs (blood pressure, heart rate, temperature), conducting laboratory tests (blood and urine analysis), performing physical examinations, and using electrocardiograms (ECGs) to monitor heart health. 6. Exploratory Assessments • Although this study primarily focuses on safety, researchers will also conduct exploratory assessments to observe any potential positive effects of NTRX-07 on brain function and symptoms of AD. These will include: o Cognitive Testing: * Standard tests like the AD Assessment Scale-Cognitive Subscale (ADAS-cog) and the Mini-Mental State Examination (MMSE) will be used to evaluate any changes in cognitive function. o Brain Imaging: * MRI scans will help assess changes in brain structure and inflammation. o Biomarkers: * Blood and CSF samples will be analyzed for specific biomarkers related to inflammation, brain health, and AD progression. 7. Eligibility Criteria * Inclusion Criteria: * Individuals aged 65-88 with a confirmed diagnosis of MCI or mild to moderate AD. * Must have a caregiver who can assist with the study requirements. * Must be able to undergo specific procedures like MRI scans and CSF sampling. * Exclusion Criteria: * Individuals with other significant health conditions or history of neurological disorders other than AD. * Those currently participating in another clinical trial or have certain medication restrictions. 8. Importance of the Study AD is a progressive condition that affects memory, thinking, and behavior. Current treatments only manage symptoms temporarily, and there is an need for new therapies. NTRX-07 is a novel drug that has shown promise in animal studies, potentially reducing brain inflammation, clearing harmful proteins, and improving memory and learning. This study is an essential step toward understanding if NTRX-07 can offer a safe and effective treatment option for people with AD. 9. Summary This clinical trial is designed to test the safety and processing of a new drug, NTRX-07, in people with MCI or mild to moderate AD. Participants will be carefully monitored for any side effects while researchers also gather data on the drug's impact on brain function. If successful, this study could lead to more advanced trials and, ultimately, a new treatment option for those affected by AD.

Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD)

This multi-site study will be the first to evaluate the dose-dependent effects of t-PBM in amnestic Mild Cognitive Impairment (aMCI) and early Alzheimer's Disease (AD) (CDR of 0.5-1, FAST 1-4; age 65-85) in a randomized clinical trial of 8 weeks of t-PBM vs. sham. At baseline, all subjects will complete initial neuropsychological testing. To elucidate mechanisms of action of t-PBM, prior to treatment, subjects will undergo neuroimaging related to critical features of AD: tau 18F MK-6240 load (PET), measures of brain bioenergetics (31P-MRS), and functional connectivity (rs-fMRI). After undergoing target engagement testing (t-PBM session performed during fMRI to detect BOLD changes with active t-PBM), subjects will then be randomized to t-PBM/sham and complete 24 t-PBM/sham treatments, \~11 min per day, 3 days per week, for 8 weeks. t-PBM will be administered via continuous, 808 nm wavelength laser delivery to the forehead bilaterally (at standard EEG electrode positions F4, F3).

A Phase 2 Clinical Study of Simenafil Hydrochloride Tablets in the Treatment of Alzheimer's Disease

This study is a multicenter, randomized, double-Blind, placebo-controlled Phase 2 clinical study to evaluate the efficacy and safety of Simenafil Hydrochloride Tablets in the treatment of participants with Alzheimer's Disease

A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).

The main purpose of this study is to determine if participants who previously took donanemab get clinical benefit when they receive annual doses. For each participant, the study will last up to 2.5 years and will include 6 visits.

Triage Survey for Neurology Research Eligibility

TRIAGE-Neuro is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored neurology clinical trials.

A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)

The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.

Adaptation and Normalization of a Verbal Episodic Memory Test in French Sign Language

To date, neuropsychological assessment of deaf signing persons is complicated by a lack of resources, especially the absence of tools available in French Sign Language (LSF). This is due to perceptual and cultural differences, and in particular the linguistic differences between French and LSF. This lack of resources significantly hinders access to care for deaf patients, as neuropsychological assessment is often a key clinical criterion in the diagnosis of certain neurological pathologies (Alzheimer's disease in particular) and enables coherent care plans to be drawn up, for example in the aftermath of strokes or traumatic brain injuries. In particular, episodic memory (which refers to the ability to memorise information anchored in a specific context) is a cognitive domain that is sensitive to pathologies such as Alzheimer's disease, but it is not currently possible to assess it with deaf signing patients. The aim of this study is to create a memory assessment test adapted to a deaf population that expresses in LSF and to normalize this test on this same population. The aim is to provide a diagnosis assessment tool, which currently does not exist in France, to improve access to care for deaf people. This project could then be extended to the creation of tests for other cognitive domains (executive functions, attention, social cognition, etc.) and to prospects for cognitive remediation. The 16-item Free and Cued Recall test (RL-RI 16) is the best choice because it is easy to use and accurate enough to assess each stage of episodic memory. These qualities make it a decisive tool in certain differential diagnosis.

Alzheimer's Tau Platform: Master Protocol

The goal of the Alzheimer's Tau Platform (ATP) is to evaluate the safety and effectiveness of tau-directed therapies, alone or in combination with the anti-amyloid monoclonal antibody, donanemab, in adults aged 50-80 with late preclinical or early prodromal Alzheimer's disease. This platform trial allows for the simultaneous testing of multiple tau therapies under a shared master protocol. This means that multiple investigational products will be tested simultaneously or sequentially. Each investigational product will be tested in a regimen. The main questions the platform trial aims to answer are: * Does a tau-directed therapy, alone or in combination with donanemab, reduce tau buildup in the brain compared to donanemab alone? * Does a tau-directed therapy, alone or in combination with donanemab, slow disease progression based on brain imaging, fluid biomarkers, and measures of memory and thinking? Participants will: * Be randomized to a treatment regimens, each containing different tau therapies. The exact number of treatment regimens that will active at the time of screening will change over time. * Receive donanemab or placebo for 6 months, followed by 24 months of tau therapy alone or in combination with donanemab. * Undergo regular cognitive testing, brain scans (MRI/PET), and biomarker assessments over 30 months Participants will have an equal chance to be randomized to all regimens that are active at the time of screening. Once randomized to a regimen, participants will be randomized to one of three arms: (1) tau therapy alone, (2) a combination of donanemab and tau therapy, or (3) donanemab alone. New regimens will be continuously added as new investigational products become available. The Alzheimer's Tau Platform Trial will enroll additional participants as each new regimen becomes available. ATP will launch with one regimen: Regimen A: AADvac1. In the future, Regimen B ("Tau2") will launch with a second tau directed therapy.

Evaluation of Imaging Characteristics of [18F]PI-2620 PET in AD and PSP Patients Using High and Low Specific Activity

This is an open-label study without randomisation. All eligible patients will receive two administrations of the investigational imaging agent \[18F\]PI-2620 at a radioactive dose of 185 MBq, one with high specific activity (≤ 5 µg tracer mass dose), another one with low specific activity (40-50 µg tracer mass dose).

Alzheimer's Tau Platform: Regimen A - AADvac1

The Alzheimer's Tau Platform (ATP) is a multi-center platform trial to evaluate the safety and effectiveness of tau-directed therapies, alone or in combination with donanemab, in adults aged 50-80 with late preclinical or early prodromal Alzheimer's disease. Regimen A will evaluate the safety and efficacy of AADvac1, alone or in combination with donanemab.