Alzheimer's disease clinical trials — recruiting now

The investigators propose a proof of concept RCT (randomized clinical trial), testing the efficacy of intranasal insulin (INI) with semaglutide, a combination therapy with strong biological plausibility to benefit impaired cognition through vascular mechanisms, in older adults with MetS (metabolic syndrome) and MCI (Mild Cognitive Impairment), who are enriched for cerebrovascular disease and at high dementia risk. The study will focus on cognitive and biological outcomes, allowing identification of relevant mechanisms.

A multicentre, interventional, multi-arm, multi-stage Phase 3 trial including randomisation, double blinding, placebo control evaluation of treatments for sustained clinical response (18 months) in symptomatic Alzheimer's Disease in a population representative of people with Alzheimer's disease in the UK.

The goal of this clinical trial is to demonstrate potential improvements in clinical trial methods relating to dementia and cognitive decline. The main questions it aims to answer are: * Can an intervention's outcome be better assessed by a latent variable ("δ") integrating cognitive performance with functional status? * Can latent biomarkers of δ guide the selection of an intervention that will modulate dementia severity? * Can a latent variable, derived from information collected remotely from caregivers, preselect subjects most likely to respond to the intervention? * Is the effect of the intervention in fact medicated by changes in the targeted biomarker? In this case, the biomarker will be a latent variable derived from several proteins measured in blood (i.e., so-called "adipokines"). The intervention will be donepezil, a medication approved for the treatment of Alzheimer's Disease, but only recently associated with adipokine changes. Participants with cognitive impairment and their caregivers will be interviewed by telephone and those newly prescribed donepezil by their provider for cognitive impairment will be recruited and enrolled. On the basis of the caregiver's report, the cognitively impaired subjects will be assigned to two groups based on a prediction of their response to donepezil. Researchers will compare those groups to see if dementia severity, as measured by δ, improves in predicted responders, and whether the change in the d-score is mediated by changes in adipokines.

The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment \[MCI\] to mild dementia due to AD).

The purpose of this study is to evaluate the safety and efficacy of the ExAblate Model 4000 Type 2.0 System as a tool to disrupt the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).

The Lived Experience Narratives in Dementia (LEND) research programme involves five work packages (WP). WP1 explores how people living with dementia use narratives and how narratives can impact them. Findings will support the development of LEND theory. WP 2-3 focus on developing the digital Online LEND Intervention, assessing its usability and acceptability, and conducting a feasibility study within NHS memory assessment and community services. Activities across the first three WPs include interviews, focus groups, user-testing sessions, engagement evaluation interviews, and a two-arm randomised feasibility trial using a range of outcome measures. Findings from this stage will inform refinement of the intervention and determine the feasibility of progressing to a future randomised controlled trial (RCT) of the Online LEND Intervention. WP4 is the Online LEND Intervention two-arm RCT. WP5 involves dissemination. The protocol for WP4 and 5 have not yet been developed and rely on results from WP1-3.

The study will examine whether 5mg melatonin (over the counter, OTC) over a 9-month period improves Alzheimer's disease (AD) biomarkers and cognitive function in two groups of individuals: those with mild cognitive impairment (MCI+) and those who are not (MCI-). AD biomarkers will be measured from cerebrospinal fluid (CSF) obtained from lumbar punctures. Cognitive function will be evaluated with routine neuropsychological tests. AS OF AUGUST 2024, THE LUMBAR PUNCTURE PROCEDURES FOR THIS CLINICAL TRIAL HAVE BEEN ELIMINATED. THAT IS, PARTICIPANTS ARE NO LONGER RECEIVING A LUMBER PUNCTURE. BUT ARE CONTINUING TO RECEIVE TWO SEPARATE BLOOD DRAWS FOR BIOMARKER TESTING.

EPICLA+ (Early-Stage Partners in Care Living Alone Plus) is a research project designed to assist people with early-stage memory loss who live alone in the community by providing early-stage related education and skill-training sessions, held via Zoom, designed to reduce stress, enhance well-being, manage challenges, and plan for the future. Researchers will gather feedback from individuals about their experience to continue to improve programs for early-stage memory loss.

The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort (TRC), and up to 550 participants in total including co-enrolled in the Alzheimer Biomarkers Consortium - Down Syndrome (ABC-DS) study. Participants enrolled in the TRC-DS will undergo longitudinal cognitive and clinical assessment, genetic and biomarker testing, as well as imaging and biospecimen collection. Using these outcome measures, researchers will analyze the relationships between cognitive measures and biomarkers of Alzheimer's disease (AD) to identify endpoints for AD clinical trials in DS that best reflect disease progression. To learn more about the study and participating sites, visit our study website at: https://www.trcds.org/. TRC-DS is collaborating with the Alzheimer's Disease Biomarker Consortium-Down Syndrome (ABC-DS) to allow study participants to be concurrently enrolled in both ABC-DS and TRC-DS, referred to as "co-enrollment". ABC-DS is a longitudinal, observational research study that is overseen at University of Pittsburgh Coordinating Center. ABC-DS participants who express interest in potentially joining a clinical trial in the future and who meet TRC-DS eligibility criteria, may choose to co-enroll in TRC-DS at an ABC-DS Site. Co-enrolled participants will adhere to the ABC-DS protocol and schedule of activities, but agree to share their data with the TRC-DS team and to receive invitations for future participation in clinical trials. Fore more information on ABC-DS please visit https://www.nia.nih.gov/research/abc-ds or http://abcds.pitt.edu/.

The New York Stem Cell Foundation (NYSCF) Research Institute is performing this research to accelerate diverse disease research using cells from the body (such as skin or blood cells) to make stem cells and other types of cells, conduct research on the samples, perform genetic testing, and store the samples for future use. Through this research, researchers hope to identify future treatments or even cures for the major diseases of our time.

The goal of this clinical trial is to learn whether home-based brain stimulation combined with virtual speech-language therapy can improve communication abilities in adults with logopenic variant primary progressive aphasia (lvPPA), a language disorder most often caused by Alzheimer's disease. The main questions the study aims to answer are: * Is combining remotely supervised transcranial direct current stimulation (tDCS) with virtual speech-language therapy feasible and acceptable for people with lvPPA? * Does this combined treatment lead to improvements in communication compared to speech-language therapy with sham (placebo) stimulation? * Do individual brain characteristics help predict who benefits most from this treatment? Researchers will compare participants who receive active tDCS plus virtual speech-language therapy to participants who receive sham (placebo) tDCS plus virtual speech-language therapy to see if active brain stimulation enhances communication outcomes. Participants will: * Complete speech-language therapy sessions delivered by video visit. * Receive either active or sham tDCS that is remotely supervised and completed at home. * Complete language and cognitive testing before and after treatment. * Undergo brain imaging and other assessments to help understand treatment response.

A prospective and retrospective cohort study of about five years will be performed on blood and cerebrospinal fluid samples taken for diagnostic reasons from recruited patients within the Neuromed Neurology Unit. Subjects with other chronic neurodegenerative diseases such as Amyotrophic lateral sclerosis (ALS), Alzheimer's disease (AD) and Parkinson's disease (PD), and healthy subjects subjected to blood sampling and / or lumbar puncture for clinical reasons will be recruited As control groups.

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.

The standard or usual workup for cognitive impairment, including Alzheimer's Disease, may include brain amyloid PET with PET/CT or PET/MR imaging. Amyloid PET is the standard imaging that was requested for you by your referring physician. This imaging can visualize your brain. With the development of new therapies for Alzheimer's disease which require amyloid PET imaging, there will be a significant increase in the number of PET scans needed to provide care to all patients. There are likely not enough PET scanners in Canada to meet this demand. Therefore, we are searching for comparable alternatives. One of the imaging devices that was introduced in the clinic is the Radialis PET imager (or RPI). Health Canada, the regulatory body that oversees the use of devices in Canada, has not approved the sale or use of the Radialis PET imager. Health Canada has allowed the Radialis PET imager to be used in this study. We would like to see whether the images obtained for the brain are comparable to those obtained from a PET/CT or PET/MRI scanner. It is a new type of PET imaging device for patients undergoing a PET scan and has been used in Canada for research. RPI is experimental, meaning that this PET scan is not used routinely in patients' care. In comparison to the standard PET devices, RPI is smaller and mobile, meaning it can be moved around easily for use. Also, it can be installed in imaging centers at a lower cost. These advantages make RPI an interesting alternative to the standard PET. However, the performance of this new imaging device has not been tested in Amyloid PET imaging in particular. As you may know, in a PET scan, we inject a radioactive material (called tracer) which can circulate in your body and visualize specific areas in your body. In amyloid PET we inject an amyloid tracer that goes to the brain and lights up certain regions of the brain. RPI was previously tested for other PET tracers and was shown to be comparable to standard PET devices. Thus, by changing the PET material (to Amyloid), we are pursuing the same aim: comparison of RPI with standard PET devices and see whether it can provide comparable images of the brain.

Alzheimer's disease (AD) is characterized by significant memory loss, toxic protein deposits (amyloid and tau) in the brain, and changes in the gamma frequency band on EEG. Gamma waves are important for memory, and in patients with AD, there are fewer gamma waves in the brain. The Tsai lab found that boosting gamma waves in AD mouse models using light and sound stimulation at 40Hz not only reduced amyloid and tau in the brain, but also improved memory. A light and sound device was developed for humans that stimulates the brain at 40Hz that can be used safely at home. The goal of this study is to see if using this device can prevent dementia in people who are at risk for developing Alzheimer's disease.

The German Dementia Registry (DEMREG) is a large-scale national prospective biomarker-based study for cognitive impairment and dementia, providing an integrated clinical research platform for research studies.

The prevalence of major neurocognitive disorders (MNCDs), particularly Alzheimer's disease, among older adults is increasing. These individuals and their caregivers often face challenges due to inefficient and poorly coordinated care transitions, negatively impacting patients, caregivers, healthcare professionals, and the healthcare system itself. To address this, the Quebec Ministry of Health and Social Services has released Phase 3 of its Ministerial Guidance on Major Neurocognitive Disorders, aiming to enhance care coordination between primary healthcare professionals and those living with MNCDs and their caregivers. Quebec's healthcare system comprises various organizations providing care and services to individuals with MNCDs. Each organization faces unique challenges hindering improvement initiatives. However, common obstacles persist: inadequate communication systems for sharing vital information, lack of access to data for measuring care transition quality, and the absence of patient/caregiver satisfaction assessments to inform service enhancements. Additionally, organizations require support in managing change. This need for improvement, coupled with the aspiration for a patient-centered learning health system (LHS), motivated the Institut national d'excellence en santé et services sociaux (INESSS), the Centre intégré de santé et de services sociaux de Chaudière-Appalaches (CISSS CA), and the research team to collaborate on adapting a proven continuous improvement program: the CoMPAS+ MNCD Program. The Program will involve reflecting on best practices and identifying local challenges within participating Family Medicine Groups (FMGs) to propose and implement solutions. The CONSTELLATIONS Living Lab project has been tasked with co-developing, implementing, and evaluating the Program's impact on care transitions over two years. These findings will inform decision-makers and stakeholders about the Program's adaptability to the Chaudière-Appalaches region, guiding local and provincial decision-makers on healthcare system improvements and emphasizing the importance of supporting an LHS.

Early Age-Related Hearing Loss Investigation (EARHLI) is a single site study that will randomize late middle age adults to either a hearing intervention (including hearing aids) or a health education intervention. Participants will be followed for 1 year. This study will provide information on reducing cognitive decline in those at risk for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD).

The overall objective of this pilot study is to assess the feasibility of a RCT comparing Lōvu-augmented with usual prenatal care at UU. This would be a critical next step toward the long-term goal to identify technology-based interventions to improve maternal mental health in the Intermountain West. The investigator's central hypothesis is that Lōvu will be both feasible and have high patient and clinician satisfaction, and that Lōvu-generated data will be a promising substrate for AI-based mental health risk stratification.

The goal of this study is to better understand if, in patients with mild to moderate hearing loss who are also experiencing mild cognitive impairment (MCI) or Alzheimer's disease and related dementias (ADRD), Over-the-Counter (OTC) hearing aids: 1. improve communication 2. Whether the magnitude of benefit depends on the patient's level of cognitive disability, 3. Whether alternative remediation (such as targeted communication strategies) offer similar benefits. Participants and a communication partner will be randomized into an OTC first or Communication Strategies first arm, where participants will receive communication strategy information customized for those with cognitive impairment.