Exploratory Clinical Study to Assess Safety and Efficacy of Xenon Gas Inhalation to Control Neuroinflammation
NCT06945614 · Healthy Volunteer Study
RecruitingThe goal of this clinical study is to evaluate safety of Xenon gas inhalation in healthy volunteers. This first phase safety clinical study is part of evaluation of the xenon gas inhalation as a therapy for neurodegenerative diseases, such as Alzheimer's disease. The investigators will administer xenon gas in low concentration to people via anesthetic machine, observe participants for sedation and any unexpected side effects, collect blood at each visit and measure the vital signs. There are four treatment groups in the study, which correspond with the duration of xenon gas treatment. Individual participation will last approximately 14 days over five visits: screening visit accompanied by the electrocardiogram, blood, and urine test; treatment visit for xenon gas inhalation treatment; and three follow up visits.
PhasePhase 1
TypeInterventional
Age55 Years – 75 Years
WhereBoston, Massachusetts, United States
SponsorGeneral Biophysics LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Acoramidis Transthyretin Amyloidosis Prevention Trial in the Young (ACT-EARLY) Study in Asymptomatic Carriers of a Pathogenic TTR Variant
NCT06563895 · Amyloidosis, Amyloid Cardiomyopathy, Transthyretin Amyloidosis
RecruitingTransthyretin amyloidosis (ATTR) is a disease where the normally occurring transthyretin (TTR) protein falls apart and forms amyloid, a sticky plaque-like substance that accumulates in different organs in the body and can cause damage to the organ. There are two ways that the TTR protein can fall apart. One way occurs as a person ages, where the normal TTR protein can fall apart and form amyloid that may no longer be sufficiently cleared by the body. This type of ATTR is known as wild-type ATTR (ATTRwt). The other way occurs when a person inherits a defective TTR gene that causes the TTR protein to spontaneously fall apart. This form of the disease is known as variant ATTR (ATTRv) and can be detected in adults by a genetic test of their TTR gene before they age. Amyloid build-up in the heart causes the heart wall to become thick and stiff and can result in heart failure and even death. Accumulation of TTR amyloid in the heart is known as transthyretin amyloid cardiomyopathy or ATTR-CM. Amyloid can also deposit in the nerve tissues leading to nerve problems. Accumulation of TTR in the nerves is known as transthyretin amyloid polyneuropathy or ATTR-PN. Acoramidis is an experimental drug designed to bind tightly to TTR in the blood and stabilize its structure, so it does not form the harmful amyloid plaques that can cause damage to organs. This study is intended to determine if treatment with acoramidis in participants with ATTRv who have not yet developed any symptoms of disease can prevent or delay the development of ATTR-CM or ATTR-PN disease. If adults with an inherited defective TTR gene are treated early before any of the symptoms of disease have developed, it may be possible to delay the onset or prevent the disease entirely.
PhasePhase 3
TypeInterventional
Age18 Years – 75 Years
WhereLa Jolla, California, United States + 102 more
SponsorEidos Therapeutics, a BridgeBio company
▾Tap for detailsClick for full details — eligibility, all locations, contacts Longitudinal Early-onset Alzheimer's Disease Study Protocol
RecruitingThe Longitudinal Early-onset Alzheimer's Disease Study (LEADS) is a non-randomized, natural history, non-treatment study designed to look at disease progression in individuals with early onset cognitive impairment. Clinical, cognitive, imaging, biomarker, and genetic characteristics will be assessed across three cohorts: (1) early onset Alzheimer's Disease (EOAD) participants, (2) early onset non-Alzheimer's Disease (EOnonAD) participants, and (3) cognitively normal (CN) control participants.
Phase—
TypeObservational
Age40 Years – 64 Years
WhereSun City, Arizona, United States + 22 more
SponsorIndiana University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Gamma Light and Sound Stimulation to Prevent Dementia in Cognitively Normal People at Risk for Alzheimer's Disease
NCT05776641 ·
Alzheimer Disease, Family Members
RecruitingAlzheimer'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.
PhaseNA
TypeInterventional
Age55 Years – 90 Years
WhereBoston, Massachusetts, United States + 1 more
SponsorMassachusetts General Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)
RecruitingThis is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.
PhasePhase 3
TypeInterventional
Age55 Years – 90 Years
WhereHomewood, Alabama, United States + 428 more
SponsorKaruna Therapeutics, Inc., a Bristol Myers Squibb company
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).
NCT07602582 ·
Alzheimer Disease, Dementia, Plaque, Amyloid
RecruitingThe 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.
PhasePhase 3
TypeInterventional
Age55 Years
WherePhoenix, Arizona, United States + 58 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)
RecruitingResearchers want to know if the study treatment called MK-2214 works to slow certain changes in the brains of people with Alzheimer's disease (AD). AD is a type of dementia that can cause loss of memory, communication (such as speech), and decision-making skills. It can limit a person's ability to do daily tasks. MK-2214 is a study treatment designed to slow down AD. The goals of the study are to learn: * If MK-2214 slows the spread of tau in the brain compared to placebo. Tau is a protein that accumulates in AD \& damages brain cells. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of a study treatment. * About the safety of MK-2214 and if people tolerate it
PhasePhase 2
TypeInterventional
Age50 Years – 85 Years
WhereIrvine, California, United States + 78 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
RecruitingThe purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
PhasePhase 3
TypeInterventional
Age60 Years – 85 Years
WhereLong Beach, California, United States + 115 more
SponsorBristol-Myers Squibb
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia
NCT06651567 · Agitation Associated With Alzheimer's Dementia
RecruitingThis is a multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of the efficacy, safety, and tolerability of ITI-1284 in patients with agitation associated with Alzheimer's dementia
PhasePhase 2
TypeInterventional
Age55 Years
WhereAnaheim, California, United States + 69 more
SponsorIntra-Cellular Therapies, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts TMS for Cognitive Decline in Aging and Preclinical AD
NCT06956300 · Prodromal Alzheimer's Disease, Preclinical Alzheimer's Disease, Healthy Aging
RecruitingIn this research study we want to learn more about the effects of non-invasive brain stimulation on motivation, memory, and brain-network function in cognitively unimpaired older adults and individuals with preclinical Alzheimer's disease. This study will use a form of non-invasive brain stimulation called repetitive Transcranial Magnetic Stimulation (rTMS). rTMS will slightly alter activity in an area of your brain that controls cognition. Changes resulting from this stimulation will be measured with behavioral tests, as well as by taking brain images with Magnetic Resonance Imaging (MRI). Participants will come in for one baseline visit followed by 10 days of daily rTMS study visits (Monday through Friday) and an evaluation visit. Then, there will be a 2-week break. After this break, they will return for another baseline visit, an additional 10 days of rTMS, and a final evaluation visit.
PhaseNA
TypeInterventional
Age40 Years – 99 Years
WhereBoston, Massachusetts, United States
SponsorMassachusetts General Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study To Assess The Feasibility Of Indivi Mobile Application In Monitoring Cognitive Performance In Aging Population
NCT07174869 · Mild Cognitive Impairment (MCI),
Mild Alzheimer Disease RecruitingThe 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.
Phase—
TypeObservational
Age50 Years – 90 Years
WhereBoston, Massachusetts, United States
SponsorIndivi AG
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
RecruitingThis study is to test LHP588 in persons who have mild to moderate Alzheimer's disease (AD) who have shown progressive mental decline in the last year and who have P. gingivalis (Pg) infection. P. gingivalis infection has been linked to the development of dementia. LHP588 is designed to target the P. gingivalis bacterium, to potentially help to halt or slow down the progression of AD and its symptoms. A saliva test will be done to determine P. gingivalis infection. Tests for AD include standard questionnaires such as MMSE and a blood test for pTau217. Treatment will be blinded, meaning the participant and the doctor will not know if the participant is receiving LHP588 or placebo. The total time for participation in the study may be up to 64 weeks. This includes a screening period (to ensure the participant is suitable for the study and the study is suitable for the participant) of up to 12 weeks, a treatment period of up to 48 weeks, and a safety follow-up period of 4 weeks after the last dose of the study drug to check the participant's overall health. Treatment is a once-a-day capsule. Caregiver participation is required. The study requires the participant to visit the study center (with the caregiver) at least 20 times within 64 weeks (this does not include any unplanned visits that may be recommended by the study doctor). In addition, the study doctor or clinic staff will contact the participant via phone at least 1 time.
PhasePhase 2
TypeInterventional
Age55 Years – 80 Years
WherePhoenix, Arizona, United States + 38 more
SponsorLighthouse Pharmaceuticals, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
RecruitingThe 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).
PhasePhase 3
TypeInterventional
Age50 Years – 90 Years
WherePhoenix, Arizona, United States + 149 more
SponsorHoffmann-La Roche
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
RecruitingThe 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).
PhasePhase 3
TypeInterventional
Age50 Years – 90 Years
WhereBirmingham, Alabama, United States + 142 more
SponsorHoffmann-La Roche
▾Tap for detailsClick for full details — eligibility, all locations, contacts Cognitive Neurology Unit Clinical Registry
RecruitingA Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's Disease
Phase—
TypeObservational
Age50 Years – 95 Years
WhereBoston, Massachusetts, United States
SponsorBeth Israel Deaconess Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Use of a Mobile Brain-Body Imaging Approach to Evaluate the Effects of Rhythmic Auditory Stimulation on Gait and Brain Function in Alzheimer's Disease
NCT07659964 ·
Alzheimer Disease (AD), Mild Cognitive Impairment (MCI)
RecruitingAlzheimer's Disease (AD) is associated with impairments in both gait and cognition, significantly increasing fall risk. Falls are a leading cause of injury-related disability in older adults, and individuals with AD experience a nearly threefold higher rate of falls compared to neurotypical older adults. There is an urgent need for fall prevention interventions tailored to the unique deficits of individuals with AD. Converging evidence suggests that interventions aiming to reduce fall risk in AD should target both gait and cognition. Rhythmic music interventions, such as Rhythmic Auditory Stimulation (RAS) can harness global brain activation and auditory-motor entrainment to facilitate high-intensity exercise to alleviate AD-related neurocognitive and gait dysfunction. This study aims to assess the neural correlates of gait dysfunction in people with AD, evaluate if baseline neurocognitive impairment is predictive of the effects of RAS, and evaluate RAS benefits for individuals with AD.
PhaseNA
TypeInterventional
Age50 Years – 90 Years
WhereBoston, Massachusetts, United States
SponsorBoston University Charles River Campus
▾Tap for detailsClick for full details — eligibility, all locations, contacts The goal of this clinical trial is to learn if mindfulness meditation can improve outcomes in older adults with and without cognitive impairment. The main questions it aims to answer are: 1. How does mindfulness impact thinking and memory? 2. How does mindfulness influence brain function and structure? 3. How does mindfulness affect daily function and quality of life? Researchers will compare all outcomes to one other groups. In one group, individuals will participate in a mindfulness class intervention; in the other group, individuals will not engage in any active interventions immediately, but will be placed on a waitlist for the mindfulness intervention. Researchers will compare all outcomes between the groups groups to determine whether the mindfulness interventions leads to greater improvement compared to no intervention (waitlist group). Participants will: * Be randomly assigned to participate in the mindfulness intervention, or no immediate intervention (waitlist) * Complete paper-and-pencil cognitive testing, surveys, computerized tasks, and neuroimaging measures (EEG and MRI) before and after the intervention Outcomes will be assess at baseline, 2 months, 4 months and 6 months.
PhaseNA
TypeInterventional
Age50 Years – 100 Years
WhereBoston, Massachusetts, United States
SponsorVA Boston Healthcare System
▾Tap for detailsClick for full details — eligibility, all locations, contacts PET Brain Imaging in Multiple Sclerosis, Alzheimer's Disease, and Other Neurological and Neuropsychiatric Diseases
RecruitingThe specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2. A pilot substudy aims to establish the non-inferiority of \[F-18\]PBR06 as compared with Carbon-11 \[C-11\] labeled "Peripheral Benzodiazepine Receptor 28" (PBR28) PET in patients with RRMS. Hypothesis: The working hypothesis is that there is microglial activation in multiple sclerosis and Alzheimer's disease as compared to healthy controls and that the pattern/ regional distribution of microglial activation is different in Multiple Sclerosis (MS) versus AD and correlates with disease severity and comorbidities. In addition, the investigators hypothesize that \[F-18\]PBR06-PET scans will be at least as good as \[C-11\]PBR28-PET scans, the current gold standard.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years – 85 Years
WhereBoston, Massachusetts, United States
SponsorBrigham and Women's Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Assess Fibrin in Brains With AD/ADRD
NCT05336695 ·
Alzheimer Disease, Dementia of Alzheimer Type
RecruitingThe goal of this project is to quantify brain fibrin content using 64Cu-FBP8-PET in the brains of subjects ranging from cognitively normal to clinically diagnosed with ADRD to evaluate potential regional differences.
PhasePhase 1 / Phase 2
TypeInterventional
Age55 Years – 90 Years
WhereBoston, Massachusetts, United States
SponsorMassachusetts General Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Triage Survey for Neurology Research Eligibility
RecruitingTRIAGE-Neuro is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored neurology clinical trials.
Phase—
TypeObservational
Age18 Years
WhereBoston, Massachusetts, United States + 2 more
SponsorAdams Clinical
▾Tap for detailsClick for full details — eligibility, all locations, contacts