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AI · Alzheimer’s

Намерени 70 изпитвания за "Alzheimer’s" Стр. 2 от 4

Набира участници Фаза 3

A Double-blind Dual Study Assessing Safety and Efficacy of Buntanetap in Participants With Early AD

Early Alzheimers Disease

The goal of this clinical trial is to learn if buntanetap/Posiphen works to treat early Alzheimer's disease in adults aged 55-85. It will also learn about the safety of buntanetap/Posiphen. The main questions it aims to answer are: * Does buntanetap/Posiphen improve cognition as measured by ADAS-Cog13? * Does buntanetap/Posiphen improve function as measured by ADCS-iADL? * What medical issues do participants have, if any, when taking buntanetap/Posiphen? Researchers will compare buntanetap/Posiphen to a placebo (a look-alike substance that contains no drug) to see if buntanetap/Posiphen works to treat early Alzheimer's disease. Participants will: * Take buntanetap/Posiphen or a placebo every day for 18 months * Visit the clinic periodically for checkups, tests, and questionnaires (screening visits, enrollment, month 1, month 3, month 6, month 9, month 12, month 15, month 18), including a volumetric MRI at month 6 and month 18 * Complete pre- and post-clinic visit phone calls

Начало: 04.02.2025 Край: 01.06.2028 Възраст: 55–85 г.

United States Annovis Bio Inc. NCT06709014

Набира участници Фаза 2/3

A Study of a Potential Disease Modifying Treatment in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation

Alzheimers Disease Dementia Alzheimers Disease, Familial

The purpose of this research study is to test the study drug, referred to as remternetug, to determine its effectiveness for the study treatment of asymptomatic (at risk) Alzheimer disease in individuals with AD-causing mutations. This study will also investigate the effects of remternetug on biomarkers (measures of the disease including brain scans, blood and spinal fluid tests), examine safety data to identify any potential benefits or risks, and examine how well participants can tolerate remternetug. Stage 1 will determine if treatment with the study drug prevents or reverses amyloid beta (Aβ) accumulation compared with placebo in participants with dominantly inherited Alzheimer's disease (DIAD). Stage 2 will evaluate the effect of early anti-amyloid treatment on downstream biomarkers of AD in treated participants compared to external control groups.

Начало: 22.11.2024 Край: 01.08.2034 Възраст: от 18 г. Лечение

Argentina, Australia, Canada +11 Washington University School of Medicine NCT06647498

Набира участници Фаза 1

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

Alzheimer 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 2 doses of either LY3954068 or placebo administered into the spinal fluid. Participants will 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.

Начало: 15.08.2024 Край: 01.02.2027 Възраст: 50–85 г.

Japan, United Kingdom, United States Eli Lilly and Company NCT06297590

Набира участници Фаза 3

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)

Psychosis Associated With Alzheimer's Disease

This 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.

Начало: 11.07.2023 Край: 07.09.2027 Възраст: 55–90 г.

Argentina, Belgium, Brazil +28 Karuna Therapeutics, Inc., a Bristol Myers Squibb compa NCT05980949

Набира участници

Study to Evaluate the Efficacy and Safety of ATNC-MDD V1(TMS With Cognitive Training) in Mild Alzheimer's Dementia

Alzheimer's Disease Dementia Brain Diseases Central Nervous System Diseases +4

The study tests the effect of the ATNC MDD-V1 on Alzheimer patients' cognitive function. The ATNC MDD-V1 uses non-invasive stimulation of both magnetic and cognitive training.

Начало: 15.05.2023 Край: 30.06.2027 Възраст: 60–85 г.

South Korea Advanced Technology & Communications NCT06088121

Набира участници Фаза 3

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases +5

The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.

Начало: 10.10.2022 Край: 01.07.2028 Възраст: 60–85 г. Лечение

Argentina, Australia, China +5 Eli Lilly and Company NCT05508789

Набира участници

Retinal Hyperspectral Imaging in Neurodegenerative Diseases

Dementia Neurodegenerative Diseases Alzheimer Disease Parkinson Disease +4

Hyperspectral retinal imaging is a non-invasive imaging modality in which a series of images of the retina are captured using light of different wavelengths. The resulting "hypercube" of data provides a wealth of information about the retinal structure. Our group has developed evidence supporting a role for this technology in the detection of retinal amyloid beta in Alzheimer's disease. We are undertaking further studies to establish the role of this method in the assessment of people with dementia, or those at risk of Alzheimer's disease. In addition, we wish to test whether the approach may have value in other forms of dementia or neurodegenerative disease such as Parkinson's disease, Lewy-Body dementia or vascular dementia.

Начало: 11.10.2021 Край: 31.12.2028 Възраст: от 30 г. Друго

Australia Center for Eye Research Australia NCT07545473

Набира участници

TAS Test: Online Motor-cognitive Tests for Early Detection of Alzheimer's Disease

Alzheimer Disease Dementia Age-related Cognitive Decline

Global dementia prevalence is rising. Alzheimer's disease (AD), the most common cause, has devastating effects on people's quality of life. AD has a preclinical (pre-AD) period of 10-20 years when brain pathology silently progresses before any cognitive symptoms appear. Current tests for pre-AD are invasive, costly and unsuitable for screening at population level. Similar to screening for pre-diabetes and carcinoma in situ, it is important to detect AD at the preclinical stage in order to offer early interventions before the pathology progresses to the irrerversible degenerative stage. In the study, research will develop a new scalable test (TAS Test) by combining two innovative ideas: hand-movement tests to detect pre-AD \>10 years before cognitive symptoms begin; and computer vision so people can "self-test" online using home computers. This unique approach builds on recent discoveries that hand-movement patterns change in pre-AD. The research team will use exquisitely precise computer vision methods to automatically analyse movement data from thousands of participants, and combine this with machine learning of overall motor-cognitive performance. The project team has access to 3 well-phenotyped cohorts, \>10,000 existing participants and a cutting-edge assay for a blood AD biomarker, ptau181. The research team will develop a TAS Test algorithm to classify hand-movement and cognitive test data for pre-AD risk (p-taua181 levels) and determine TAS Test's precision to prospectively predict 5-year risks of cognitive decline and AD.

Начало: 05.03.2021 Край: 01.12.2030 Възраст: от 50 г.

Australia University of Tasmania NCT05194787

Набира участници

Remotely-supervised Neuromodulation in PPA

Primary Progressive Aphasia(PPA) Progressive Aphasia Progressive Aphasia in Alzheimer's Disease Logopenic Progressive Aphasia (LPA) +2

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.

Начало: 15.04.2026 Край: 01.08.2029 Възраст: от 40 г.

United States Maya Henry NCT07260253

Набира участници Фаза 1/2

FACE Phase II (a Stage II Trial)

MCI Subjective Cognitive Decline (SCD) Mild Behavioral Impairment

How to ensure adherence to computerized cognitive training in unsupervised circumstances (e.g., at-home, self-administered) in older adults at risk for Alzheimer's disease (AD) or AD related dementia (AD/ADRD) is understudied. The objective of the R33 study is to test a novel facial expression-based personalization engine (FPE) for monitoring and modulating real-time effective engagement, with an ultimate goal of enhancing long-term adherence in unsupervised cognitive training in older adults at risk for AD/ADRD. Here, Effective engagement is defined as the extent to which someone is actively engaged and performing with significant attention and enjoyment while training, addressing a balance between adherence and cognitive gains/plasticity from the training. Based on previous work, the hypotheses include that (1) mental fatigue revealed in facial expressions will reflect a trainee's degree of effective engagement, which can be modified by modulating task novelty; (2) the proposed FPE will ensure the effective engagement in cognitive training by monitoring trainee facial expressions and modulating training in response, promoting the trainee's long-term adherence to the training and cognitive plasticity. A Stage II intervention efficacy study will be conducted to compare effective engagement and adherence in unsupervised cognitive training between training programs with vs. without FPE in older adults at risk for AD/ADRD. The proposed FPE may assist in monitoring and improving effective engagement and adherence in older adults with unsupervised cognitive training. In the current application, FPE in a cognitive training program called speed of processing training will be tested. However, such FPE may be embedded to any computerized cognitive training in future studies to help address adherence related issues.

Начало: 31.10.2025 Край: 31.08.2028 Възраст: 60–89 г.

United States Stanford University NCT07130669

Набира участници Фаза 3

CN012-0025: A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated with Alzheimer’s Disease (ADAGIO-3)

Agitation Associated with Alzheimer’s Disease

Trial status: Authorised Reported adverse events (AEs), TEAEs, serious AEs, and TEAEs leading to study withdrawal and deaths, AEs of special interest, Assessment of abnormal involuntary movements or restlessness, Body weight, Blood pressure and heart rate, Laboratory evaluations, Suicidal ideation, Assessment of cognition, Assessment of urinary retention. Incidence of any Treatment-Emergent Adverse Events (TEAEs).

Начало: 21.10.2025 Възраст: от 18 г.

Bulgaria, Croatia, Czech Republic +8 Bristol-Myers Squibb Services Unlimited Company 2024-519994-20-00

Набира участници Фаза 2

A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease

Alzheimer's Disease

This is a multicentre, randomized, double-blind, placebo-controlled, parallel group Phase II study to evaluate the efficacy and safety of VHB937 in participants with early AD followed by an Extension. The double-blind part is 72 weeks long, followed by an extension.

Начало: 07.08.2025 Край: 31.12.2030 Възраст: 50–85 г. Лечение

Australia, Canada, Czechia +9 Novartis Pharmaceuticals NCT07094516

Набира участници Фаза 3

A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled, Two-Stage Adaptive Design, Platform Trial of Investigational Treatments for Primary Prevention of Disease Progression in Dominantly Inherited Alzheimer’s Disease

Dominantly Inherited Alzheimer’s Disease (DIAD)

Trial status: Authorised Stage 1 and Stage 2: • Incidence and severity of TEAEs, o serious TEAEs, o serious drug related TEAEs, o TEAEs leading to discontinuation, o TEAEs resulting in death • ARIA noted by MRI • laboratory parameters • vital signs • ECGs (if done), Biomarker interim analyses may be used for dose-adjustment, remediation, or stopping a study drug arm for efficacy and/or futility. Biomarkers are specified for each drug based on mechanism of action and may include soluble biochemical measures (e.g., Aβ and tau), imaging measures of pathology (e.g., amyloid PET), and AD biomarker changes (e.g., atrophy measured by MRI, and neurodegeneration measured by NfL)., Remternetug arm specific Secondary end point Stage 1: Secondary efficacy endpoints include: • The proportion of participants who are amyloid positive (CL level ≥ 16.3) at the end of Stage 1, • Change in CSF pTau217/Tau217 ratio, • Change in CSF pTau231/Tau231 ratio, and • Change in CSF 3-repeat isoform of MTBR (MTBR-3R)., Remternetug arm specific Secondary end point Stage 2: Odds ratio between the treated group and the external control group (DIAN Obs and DIAN-TU-001 placebo) of being in the lower biomarker disease progression stage based on two-stage modeling of 6 biomarkers (CSF tau phosphorylated tau at residue 153 (pTau153)/Tau153 ratio, CSF pTau205/Tau205 ratio, CSF microtubule binding region of tau 243 amino acids long (MTBR-tau243), MRI hippocampal volume, CSF NfL, and MRI precuneus thickness)., Remternetug arm specific Secondary end point Stage 2: Other secondary endpoints for Stage 2 include: • Fluid and Imaging Biomarker Efficacy Endpoints o CSF pTau217/Tau217 ratio, CSF pTau231/Tau231, CSF MTBR-3R • Clinical and Cognitive Efficacy Endpoints o A cognitive composite derived as an average of these four tests: MAC-Q, Category Fluency (Animals), FCSRT-IR, WAIS-R Digit Symbol Substitution Test, and MMSE. o CDR-SB Stage 1: Defined in each drug-specific appendix; will be an assessment of biomarkers of early-stage disease (e.g., amyloid PET, soluble amyloid, soluble phospho-tau) compared with baseline in each treatment group, Stage 2: If applicable, will be defined in each drug-specific appendix, and will be an assessment of the change in progression of biomarkers representing tau, neurodegenerative, and inflammatory pathobiological events in the disease cascade for temporally different periods of the presymptomatic phases of the disease., Remternetug arm specific Primary end point Stage 1: The primary endpoint will only use data collected from Stage 1, and will be the change from baseline in brain Aβ plaque development as measured by centiloid (CL) [11C]-Pittsburgh compound B (PiB) PET.

Начало: 30.06.2025 Възраст: от 18 г.

France, Germany, Italy +2 Washington University School Of Medicine 2024-517187-36-01

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A Postmarketing Study of LEQEMBI in South Korean Participants With Alzheimer's Disease

Alzheimer's Disease

The primary purpose of this study is to evaluate safety of LEQEMBI in the real-world clinical setting as reported by events of amyloid-related imaging abnormalities (ARIA)-edema (ARIA-E), ARIA-hemosiderin deposition (ARIA-H), symptomatic ARIA-E, symptomatic ARIA-H, and intracerebral hemorrhage (ICH) greater-than 1 centimeter (cm) in patients treated with LEQEMBI.

Начало: 24.02.2025 Край: 30.09.2029 Възраст: от 19 г.

United States Eisai Korea Inc. NCT06810960

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Mediators and Moderators of Auditory Training

Hearing Handicap

The goal of this clinical trial is to learn how Auditory Training (AT) may help people better understand speech in noisy environments. As people get older, it becomes harder for them to hear speech clearly when there is background noise. This can be frustrating, and it can affect their independence and quality of life. AT is often used to support people with and without hearing loss, especially when a person is not a good candidate for a hearing aid or when amplification from a hearing aid does not improve performance. The investigators want to gather reliable data to understand how AT works and what affects its success. The main questions the trial aims to answer are: * How do different types of sounds influence the effectiveness of auditory training? * Which auditory training approaches are most successful in improving speech understanding? * How do personal traits impact the results of auditory training? The investigators will study a large and diverse group of 1,260 participants, including both young and older adults, to evaluate various auditory training approaches. You will: * Take part in auditory training sessions that include different types of auditory tasks. * Complete tests that measure how well they understand speech in both quiet and noisy settings. * Complete surveys on personal data like demographics, hearing challenges and other factors to help researchers understand what might influence training results. The investigators will measure and compare the results of these approaches to find out which ones are most effective. This could help people who are at risk of cognitive decline, like those at risk for Alzheimer's disease.

Начало: 06.01.2025 Край: 31.05.2027 Възраст: 18–85 г.

United States Northeastern University NCT06812273

Набира участници Фаза 2/3

A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation

Alzheimers Disease Dementia Alzheimers Disease, Familial

The purpose is to evaluate the biomarker effect, safety, and tolerability of investigational study drugs in participants who are known to have an Alzheimer's disease (AD)-causing mutation. Stage 1 will determine if treatment with the study drug prevents or slows the rate of amyloid beta (Aβ) pathological disease accumulation demonstrated by Aβ positron emission tomography (PET) imaging. Stage 2 will evaluate the effect of early Aβ plaque reduction/prevention on disease progression by assessing downstream non-Aβ biomarkers of AD (e.g., CSF total tau, p-tau, NfL) compared to an external control group from the DIAN-OBS natural history study and the DIAN-TU-001 placebo-treated participants.

Начало: 22.11.2024 Край: 30.08.2034 Възраст: от 18 г. Лечение

Argentina, Australia, Canada +11 Washington University School of Medicine NCT05552157

Набира участници

Combating Alzheimer's Through Sleep and Exercise

Alzheimer Disease Dementia

The purpose of this research is to see how sleep and exercise affects dementia risk over time.

Начало: 01.03.2023 Край: 30.12.2028 Възраст: 45–80 г.

United States University of Miami NCT04855630

Набира участници Фаза 1

PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease

Parkinson's Disease Dementia Alzheimer's Disease ALS +1

Background: About 5 million adults in the U.S. have Alzheimer s disease or another adult-onset neurodegenerative disorder. Many studies have found that inflammation in the brain contributes to these diseases. Researchers want to find a better way to measure this inflammation. Objective: To learn whether COX-1 and/or COX-2 is elevated in the brains of individuals with neurodegenerative brain disease compared to healthy volunteers. Eligibility: Adults age 18 years and older in good general health who have an adult-onset neurodegenerative dementia, such as AD, FTD, corticobasal syndrome, Huntington s disease, or MCI, ALS and healthy adult volunteers enrolled in protocols 01-M-0254 or 17-M-0181. Design: Participants will be screened with medical history, physical exam with vital signs, and lab tests. They will have a neuropsychological testing. Their heart function will be measured. Participants will have a magnetic resonance imaging (MRI) scan. The MRI scanner is a metal tube surrounded by a strong magnetic field. Participants will lie on a table that slides in and out of the tube. The machine makes noise. Participants will get earplugs. Participants will have 2 PET scans. They will be injected with the study drugs through an intravenous catheter placed in an arm vein. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. A plastic mask will be molded to their head to keep them from moving. A thin plastic tube will be put into an artery at the wrist or elbow crease area. This will be used to draw blood during the scan. Participants will have 2-5 study visits. Participation lasts 1 week to 4 months, depending on scheduling.

Начало: 17.08.2021 Край: 03.10.2030 Възраст: 18–99 г.

United States National Institute of Mental Health (NIMH) NCT04396873

Набира участници Фаза 2

A Novel Drug for Borderline Personality Disorder

Borderline Personality Disorder

Borderline Personality Disorder (BPD) is one of the most prevalent psychiatric disorders with high morbidity and mortality. It affects the lives of millions worldwide and is often highly incapacitating, leading to significant psychosocial dysfunction. Moreover, nearly all patients have experienced suicidal ideation and about 10% actually commit suicide, a rate almost 50 times higher than in the general population. Mostly young women are at greater risk for the disorder and are three times more likely to be diagnosed with BPD than men. BPD aetiology is complex and could be explained by both biological and environmental factors. Among the environmental factors, sexual or physical abuse, parental divorce, loss or illnesses are identified as the most common ones. These factors can induce dysfunctional behaviours, which might cause emotional dysregulation, high impulsivity and frequent self- injurious behaviour. However, there are no pharmacologic interventions that are known to be specifically effective to treat BPD. Therapeutic options for this devastating disorder is still far from adequate for treating acute illness episodes, relapses, and recurrences and in restoring premorbid functioning. In addition, some patients are unable to tolerate existing therapies for BPD, which leads to either frequent changes in medications or to non-adherence. Therefore there is an urgent need for the development of more rapidly effective treatments for BPD. A growing body of evidence suggests that glutamatergic neurotransmission, in particular N-methyl-D-aspartate (NMDA) subtype may play a role in the pathophysiology of multiple psychiatric disorders. This has led to various clinical trials with glutamate modulating drugs. The trial drug is an uncompetitive NMDA receptor antagonist approved for Alzheimer's disease is increasingly being studied in a variety of non-dementia psychiatric disorders. Results from these studies have proved that the trial drug was safe and well tolerated and has the potential for use in the treatment of psychiatric disorders. To date, there are no published data on the use of trial drug in the treatment for BPD. Therefore, the investigators intend to study the efficacy of this novel drug as an addition to ongoing therapy with atypical antipsychotics in patients with Borderline Personality Disorder. This study will recruit 150 BPD patients. The patients will be randomly allocated to receive either the study medication (20mg/ day) or placebo via oral administration for twelve weeks. To observe the efficacy of the trial treatment, all participants will be assessed at various time intervals for different borderline and cognitive symptoms.

Начало: 01.01.2015 Край: 01.12.2025 Възраст: 18–65 г. Лечение

Australia The Alfred NCT02097706

Предстои набиране Фаза 2/3

To Evaluate the Efficacy, Safety, and Tolerability of Dronabinol Oral Solution for Agitation in Patients With Alzheimer's Disease

Agitation in Dementia

This study tests a medication called dronabinol in people with Alzheimer's disease. First, participants go through up to 4 weeks of screening. Then, over 2 weeks, the dose of the study drug is slowly increased. For the next 10 weeks, participants stay on either dronabinol or a placebo. After finishing this part of the study, participants can join a 6-month extension where everyone receives dronabinol. Those already on the drug stay on their same dose, while those who were on placebo gradually increase their dose over 2 weeks. All participants take dronabinol for the rest of the extension, then complete a final safety check 4 weeks after stopping the medication. Usual medical treatments are continued throughout the study.

Начало: 01.05.2026 Край: 01.08.2028 Възраст: 50–90 г. Превенция

Australia Benuvia Therapeutics Inc. NCT07422311

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