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 + 77 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts In this study, the investigators will be examining the effects of the deep repetitive transcranial magnetic stimulation (rTMS) using the H1 coil in patients over the age of 60 diagnosed with mild to early-moderate Alzheimer's disease (AD) or mild cognitive impairment (MCI) and comorbid Major Depressive Disorder (MDD) who have been unable to tolerate or failed to respond to antidepressant medications. The coil was designed to stimulate deeper regions of the left dorsolateral prefrontal cortex (DLPFC). Based on prior research, the investigators propose that active stimulation with the H1 coil for 4 weeks may result in significant remission rates and will be tolerable and safe.
PhaseNA
TypeInterventional
Age60 Years
WhereToronto, Ontario, Canada
SponsorRotman Research Institute at Baycrest
▾Tap for detailsClick for full details — eligibility, all locations, contacts Single-center Prospective Longitudinal Study of Taste in Patients With Cognitive Disorders at Different Stages of Severity (Isolated Cognitive Complaint, Minor or Major Neurocognitive Alzheimer-type Disorders) by Analysis of Gustatory Evoked Potentials
NCT05888961 · Cognitive Disorders
RecruitingThe aim of the MAPEG 2 study is to explore gustatory function and to follow its evolution in the 4 following groups of participants: * Healthy subjects * Participants with isolated cognitive complaint * Participants with minor neurocognitive disorder * Participants with mild and moderate Alzheimer-type major neurocognitive disorders For this purpose, we want to compare the results of the following tests: * Subjective taste tests (tasting solutions, answering food preference questionnaires), * Gustatory evoked potential (GEP) parameters, recorded by electrodes placed on the scalp, * And nutritional parameters (hormones of food intake by blood test, measurement of the global body composition). Identifying and following the evolution of early taste disorders in case of cognitive disorders could improve the diagnosis of Alzheimer\'s disease in two ways: * To allow an early diagnosis of Alzheimer\'s disease, and thus improve its management, * To define groups of subjects at risk of developing Alzheimer\'s disease in later years.
PhaseNA
TypeInterventional
Age18 Years
WhereDijon, France
SponsorCentre Hospitalier Universitaire Dijon
▾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 Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease
NCT05649514 · Neuropathology, Cognitive Decline, Sleep Disorder
RecruitingAlzheimer's disease (AD) is characterised by a progressive loss of memory and cognitive function. In the early stages of AD, there is a progressive accumulation of molecules: β-amyloid peptides (Aβ) in the brain. There is a link between the accumulation of Aβ peptides and the deterioration of sleep, but current knowledge does not confirmed this link. The objective of this study is to define whether there is a link between cognitive decline and sleep disorders. If a correlation is found, this could allow earlier treatment of sleep disorders in the longer term in order to slow the development of AD. Treatment protocols in the field of Alzheimer's disease (AD) are directed towards participants at risk of developing the disease, such as those who carry at least one ε4 allele on apolipoprotein E (APOE ε4). An individual with 2 ε4 copies has a 30-55% risk of developing AD with an age of onset around 68 years and a dose effect of the allele on risk and age of onset of symptoms.
PhaseNA
TypeInterventional
Age50 Years – 85 Years
WhereMontpellier, Hérault, France
SponsorUniversity Hospital, Montpellier
▾Tap for detailsClick for full details — eligibility, all locations, contacts Bumetanide in Patients With Alzheimer's Disease
RecruitingThis study aims to investigate bumetanide in patients with biologically confirmed Alzheimer's disease (AD). Bumetanide is a potent diuretic administered orally and is FDA approved for the treatment of edema and hypertension. Repurposing bumetanide as a medication for AD has been proposed based on data that demonstrated its ability to "flip" the APOE genotype-dependent transcriptomic signatures in AD mouse and cell culture models. Critically, this discovery was subsequently explored in Electronic Health Record cohorts, which revealed that among individuals over the age of 65, bumetanide exposure was significantly associated with a lower prevalence of AD in three independent datasets. Primary Objective: To evaluate the safety and tolerability of bumetanide when administered to participants with biomarker-confirmed Alzheimer's disease. Secondary Objective: To evaluate the clinical and biomarker effects of bumetanide in participants with mild cognitive impairment or mild dementia due to Alzheimer's disease.
PhasePhase 2
TypeInterventional
Age50 Years – 85 Years
WhereStanford, California, United States
SponsorStanford University
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Oral EX039 in Subjects with Mild Alzheimer's Disease
RecruitingThis is a phase 2, randomized, double-blind, placebo-controlled study of oral EX039 as add-on to Acetylcholine Esterase Inhibitors in subjects with mild Alzheimer's disease.
PhasePhase 2
TypeInterventional
Age50 Years – 80 Years
WhereTaipei, Taiwan
SponsorExcelsior
▾Tap for detailsClick for full details — eligibility, all locations, contacts dTMS for Subjective Cognitive Decline
NCT06095063 ·
Alzheimer Disease, Subjective Cognitive Decline
RecruitingDeep transcranial magnetic stimulation (dTMS) is a brain stimulation technique that involves generating a brief magnetic field in a coil that is placed on the scalp. The magnetic field passes through the skull and induces a weak electrical current in the brain that briefly activates neural circuits at the stimulation site. The Brainsway dTMS H7-Coil is able to target an area of the brain that has been shown in studies to be linked to greater resilience to cognitive decline. In this study, the investigators will combine dTMS with cognitive training in older adults with subjective cognitive decline (SCD) and examine the effect of this treatment on memory, other cognitive abilities, and mood. In addition, the investigators will examine the combined effects of dTMS and cognitive training on brain activity as measured using electroencephalography (EEG). Approximately 30 older adults from ages 55 to 70 with SCD and a positive family history of Alzheimer's disease will be enrolled in this study.
PhaseNA
TypeInterventional
Age55 Years – 70 Years
WhereToronto, Ontario, Canada
SponsorRotman Research Institute at Baycrest
▾Tap for detailsClick for full details — eligibility, all locations, contacts The Effects of Social Isolation and Social Interaction on the Risk of Dementia Progression and Brain Function in SCD (Subjective Cognitive Decline, SCD)
NCT06335836 · Social Isolation, SCD, Subjective Cognitive Decline
RecruitingThe goal of this clinical trial is to learn about the effects of social isolation and social interaction on the risk of dementia progression and brain function in SCD 1. To explore the association between social isolation and lonely SCD populations and the occurrence and progression of MCI and AD through cross-sectional studies, cohort studies and randomized controlled trials of SCD; 2. To clarify the correlation between different carrier states, resting brain function connectivity characteristics, and dual-task walking ability of APOEε4 allele and the progression of SCD to MCI and AD during the cognitive progress of people with SCD affected by social isolation; 3. Establish a predictive model of cognitive decline from SCD to MCI and AD, and apply it to the SCD population to carry out individualized interventions; 4. Confirm the protective effect of social interaction on cognitive level and brain function in SCD patients.
Phase—
TypeObservational
Age45 Years – 85 Years
WhereNanjing, China, Jiangsu, China
SponsorThe First Affiliated Hospital with Nanjing Medical University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Links Between Self-awareness and Sociocognitive Processes in Neurodegenerative Diseases
NCT07531732 · Frontotemporal Dementia, Behavioral Variant,
Alzheimer Disease RecruitingThis monocentric, non-interventional study (SELFSOC) investigates the relationship between self-awareness and social cognition in patients with behavioral variant frontotemporal dementia (bvFTD) and Alzheimer's disease (AD). The primary objective is to assess metacognitive efficiency related to social cognitive performance using a computerized facial emotion recognition task combined with confidence judgments. Metacognitive indices (including Mratio) will quantify the correspondence between subjective and objective performance. Thirty-four participants (17 bvFTD, 17 AD; age 50-80; MMSE ≥20) will complete two study visits involving tasks assessing emotion recognition, theory of mind, and memory.
Phase—
TypeObservational
Age50 Years – 80 Years
WhereParis, France
SponsorAssistance Publique - Hôpitaux de Paris
▾Tap for detailsClick for full details — eligibility, all locations, contacts Improving Prognostic Confidence in Neurodegenerative Diseases Causing Dementia Using Peripheral Biomarkers and Integrative Modeling
NCT06529744 · Dementia,
Alzheimer Disease, Dementia With Lewy Bodies
RecruitingTo develop a model to predict disease progression in a large cohort of patients across a variety of neurodegenerative diseases, including Mild Cognitive Impairment (MCI) and dementia due to any neurodegenerative disease, including Alzheimer's Disease (AD), Lewy Body Disease (LBD), Vascular Disease (VaD) and Frontotemporal lobar degeneration (FTLD).
Phase—
TypeObservational
Age30 Years – 95 Years
WhereNorth York, Ontario, Canada + 3 more
SponsorUniversity Health Network, Toronto
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab
RecruitingThe primary purpose of this study is to investigate the characteristics of amyloid related imaging abnormalities (ARIA) and investigate the treatment continuation status (e.g., continuation, interruption) after the onset of ARIA in routine clinical practice in participants treated with lecanemab.
Phase—
TypeObservational
Age18 Years
WhereHiroshima, Japan + 2 more
SponsorEisai Co., Ltd.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Neurodegeneration and Neuronal Fluctuations in Lewy Body Disease and Alzheimer's Disease
NCT06057909 · Lewy Body Disease,
Alzheimer Disease, Healthy
RecruitingThe purpose of this research study is to investigate how the brain, memory, thinking, and motor behavior change both in individuals with movement and/or cognitive disorders, as well as healthy individuals. Researchers will look at measurements of memory, thinking, brain wave and muscle activity, daily functioning, and brain scans to learn more about brain disorders such as Alzheimer disease and Lewy body disease.
Phase—
TypeObservational
Age50 Years – 95 Years
WhereScottsdale, Arizona, United States
SponsorMayo Clinic
▾Tap for detailsClick for full details — eligibility, all locations, contacts Tau Networks in Psychotic Alzheimer's Disease
RecruitingThis research project aims to understand the brain mechanisms behind the manifestation of psychotic symptoms in Alzheimer´s disease (AD), and nature of the unique relationship with tau pathology. Amongst the cognitive manifestations of psychosis are impairments related to frontal circuits (social cognition, working memory and executive function deficits). The investigator's previous work suggests a role of tau pathology (one of the hallmarks of AD neuropathology) in the manifestation of psychosis in AD. However, the cerebral mechanisms that underly this association remain poorly understood. The overarching aim of the study is is to investigate the mechanisms by which tau network pathology may promote the presentation of psychosis in AD.
Phase—
TypeObservational
Age65 Years – 85 Years
WhereManhasset, New York, United States
SponsorNorthwell Health
▾Tap for detailsClick for full details — eligibility, all locations, contacts Georgia Memory Net Anti-Amyloid Monoclonal Antibody Registry
RecruitingThe purpose of this registry is to compile information on patients who are receiving FDA-approved anti-amyloid mAbs in the course of their clinic visits in the Emory Cognitive Neurology Clinic and in Georgia Memory Net Memory Assessment Clinics.
Phase—
TypeObservational
Age50 Years – 90 Years
WhereAlbany, Georgia, United States + 7 more
SponsorEmory University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease
NCT05949047 · Caregivers, Emotions, Emotion Regulation
RecruitingAlzheimer's Disease (AD) and Alzheimer's Disease-Related Dementias (ADRD) not only exact a heavy toll on patients, they also impose an enormous emotional, physical, and financial burden on unpaid, often family, caregivers. The strain of providing care for a loved one diagnosed with AD, often across several years, is associated with elevated depression risk and poorer overall health. Emotion regulation skills represent an ideal target for psychological intervention to promote healthy coping in ADRD caregivers. The project seeks to use an experimental medicine approach to test the efficacy and biobehavioral mechanisms of a novel, relatively brief, targeted, scalable, smartphone-based cognitive emotion regulation intervention aimed at improving psychological outcomes (i.e., reducing perceived stress, caregiver burden, and depressive symptoms) in ADRD unpaid primary caregivers as well as examine potential benefits of the caregiver intervention on quality of life in care recipients. Cognitive reappraisal is the ability to modify the trajectory of an emotional response by thinking about and appraising emotional information in an alternative, more adaptive way. Reappraisal can be operationalized via two primary tactics: psychological distancing (i.e. appraising an emotional stimulus as an objective, impartial observer) and reinterpretation (i.e., imagining a better outcome than what initially seemed apparent). The project will investigate the efficacy and underlying biobehavioral mechanisms of a novel, one-week cognitive reappraisal intervention in this population, with follow-up assessments at 2 weeks, 4 weeks, and 3 months. ADRD unpaid primary caregivers will be randomly assigned to receive training in either distancing, reinterpretation, or a no regulation natural history control condition, with ecological momentary assessments of self-reported positive and negative affect, remotely- collected psychophysiological health-related biomarkers (i.e., heart rate variability data) using pre-mailed Polar H10 chest bands, and health-related questionnaire reports. Distancing training is expected to result in longitudinal reductions in self-reported negative affect, longitudinal increases in positive affect, and longitudinal increases in HRV that are larger than those attributable to reinterpretation training and no-regulation control training.
PhaseNA
TypeInterventional
Age18 Years
WhereHouston, Texas, United States
SponsorBryan Denny
▾Tap for detailsClick for full details — eligibility, all locations, contacts Longitudinal Cognitive Assessment by BoCA
NCT04114994 ·
Alzheimer Disease, Mild Cognitive Impairment, Vascular Dementia
RecruitingThe Boston Cognitive Assessment (BoCA) is a self-administered online test intended for longitudinal cognitive monitoring. BoCA uses random not-repeating tasks to minimize learning effects. BoCA was developed to evaluate the effects of treatment in longitudinal clinical trials and available gratis to individuals and professionals.
Phase—
TypeObservational
Age50 Years
WhereMiami, Florida, United States
SponsorAlzheimer's Light LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts The Clinical Study of Synaptic Plasticity-based Lencanumab for the Treatment of Early Alzheimer's Disease
NCT06871839 · Alzheimer's Disease, Lecanemab, Functional Magnetic Resonance Imaging
RecruitingAlzheimer's disease (AD) manifests itself in cognitive decline, impaired ability to perform daily life, and a variety of behavioral and psychiatric symptoms, seriously endangering the health of the elderly. The prevalence and disability rates of AD in China remain high, and the lack of effective treatment options has brought a heavy burden to patients and their families. Early intervention is regarded as an effective strategy to improve clinical symptoms, delay disease progression and maintain current quality of life. The humanized monoclonal antibody lencanemab (Lecanemab) was approved by the U.S. FDA in July 2023 for the treatment of mild cognitive impairment or mild dementia caused by AD, and was officially approved in January 2024 in China. Lencanemab highly targets soluble and insoluble neurotoxic β-amyloid (Aβ) proteins, reducing pathogenic Aβ plaque deposition and preventing its formation in the brains of AD patients, thus reducing neurotoxicity and improving patients' cognitive functions. In addition, lencanumab may also play a neuroprotective role by modulating synaptic plasticity and regulating neural network activity in brain neurons. However, there is a lack of clinical studies to prove this mechanism. In this study, we will enroll consecutive patients with early AD treated with lencanemab infusion as well as those receiving conventional anti-dementia therapy, and comprehensively assess the effects and intrinsic molecular mechanisms of lencanemab on synaptic function and neural networks using magnetic resonance imaging, molecular imaging positron emission tomography (PET), neuropsychological assessment, and analysis of blood cerebrospinal fluid samples.
Phase—
TypeObservational
Age50 Years – 90 Years
WhereBeijing, China
SponsorCuibai Wei,Clinical Professor
▾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 (MINDSET 2)
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
WhereFullerton, California, United States + 123 more
SponsorBristol-Myers Squibb
▾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
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