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AI · Alzheimer’s

Намерени 70 изпитвания за "Alzheimer’s" Стр. 3 от 4

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Wellness Enhancement for Caregivers

Caregiver Burden

The purpose of this study is to test WECARE, a seven-week multimedia intervention designed to reduce psychosocial distress and provide education and support for caregivers. This study will include Chinese American family caregivers of persons living with Alzheimer's disease and related dementias. Participants will engage with digital learning materials and supportive resources over the course of the program. The goal is to determine whether this approach improves caregiver well-being and reduces stress related to caregiving.

Начало: 01.09.2026 Край: 01.10.2030 Възраст: 21–100 г.

George Mason University NCT07539350

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Amyloid Monoclonal Antibody Treatment in PD Patients With Coexistent AD Pathology

Parkinson Disease

This study aimed to determine the efficacy of amyloid clearance of lecanemab in patients with Parkinson's disease (PD) with amyloid co-pathology. Lecanemab, an anti-amyloid monoclonal antibody, was apporoved by the US FDA in July 2023 and in South Korea in May 2024, as a disease-modifying therapy based on its clinical efficacy and reduction of amyloid plaques in patients with early-stage Alzheimer's disease (AD). AD pathology is also common in PD, and approximately 35% of patients with PD dementia have co-existing AD pathology. Currently, no mediations have been developed to slow the progression of PD. Therefore, this study aimed to determine whether reducing the amyloid burden in patients with PD with co-exsistent AD pathology could potentially slow disease progression. To test it, patients with PD with mild cognitive impairment or early dementia, who were confirmed to have amyloid deposition through amyloid imaging, would be enrolled as a treatment arm, and the degree of reduction of amyloid plaque after 18 months of lecanemab administration would be investigated.

Начало: 01.05.2026 Край: 01.11.2030 Възраст: 50–90 г.

South Korea Yonsei University NCT07544953

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Caring for Dementia Caregivers in Ethnic Immigrant Communities

Stress and Well-being of Family Caregivers of Persons With Dementia

Many caregivers of people with Alzheimer's disease or other dementias-especially those in immigrant communities who don't speak English well-don't get access to helpful, proven support programs. This is especially true for Korean American caregivers. To address this, our team adapted an existing caregiver support program (called the Savvy Caregiver Program) to better fit Korean culture and language. This new version, called K-Savvy, is a 6-week online program taught in Korean. In an earlier small study, K-Savvy worked well: caregivers found it helpful, were willing to use it, and showed fewer symptoms of depression. Now, we want to study it more carefully to see how well it really works and why. Our study has two main goals: Goal 1: We will measure whether K-Savvy improves caregivers' well-being-specifically whether it reduces stress and depression and helps them feel more positive about caregiving. We will also look at why it works, focusing on whether it changes how caregivers think about their situation (for example, feeling less overwhelmed and more confident). Goal 2: We will talk directly with caregivers and program instructors to understand their experiences with K-Savvy. This will help us learn what worked well, what didn't, and why.

Начало: 01.05.2026 Край: 30.12.2030 Възраст: от 18 г.

United States University of Southern California NCT07550075

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Randomized Controlld Trial of Dementia Education Resources for Action

Alzheimer's Disease and Related Dementia

The goal of this intervention trial is to evaluate the effectiveness the online training program Dementia Education and Resources for Action (DERA) in improving Alzheimer's disease and related dementia-(ADRD) knowledge, stigma, and service-related self-efficacy among community health workers (CHWs). We hypothesize that participants who have completed the DERA will have improved ADRD knowledge and self-efficacy in related service and reduced stigma against ADRD and people affected.

Начало: 16.04.2026 Край: 31.08.2026 Възраст: от 18 г.

George Mason University NCT07545577

Предстои набиране Фаза 2

Study to Evaluate the Effect of HT-4253 for the Prevention of Alzheimer's Disease in APOE4 Carriers

Alzheimers Disease

Primary Objectives: To demonstrate that HT-4253 improves the amyloid risk profile by transitioning biomarker-positive APOE4 carriers from a positive, high risk APS2 score to a negative, low risk APS2 score. Secondary Objectives: * To assess the effects of HT-4253 on tau related blood biomarker progression over the study period. * To assess the effects of HT-4253 on amyloid related blood biomarker progression over the study period. * To assess the safety and tolerability of HT-4253 in the UAE population.

Начало: 03.04.2026 Край: 20.08.2027 Възраст: 50–75 г.

United Arab Emirates Halia Therapeutics, Inc. NCT07399171

Предстои набиране Фаза 1

A Phase 1 Study to Assess the Safety and Effects of Single and Multiple Doses of KS101 in Healthy Volunteers

Healthy Participants Alzheimer Disease Chronic Kidney Disease

This study is the first clinical trial involving study drug KS101. The goal of this clinical trial is to investigate whether KS101 is safe, whether it causes side effects, and how KS101 is broken down in the body, in healthy participants. This information will be used to learn more about KS101 and to determine the most effective dose for age related diseases such as chronic kidney disease and Alzheimer's Disease, with the fewest unwanted side effects. There are 3 parts to this study. In Part 1, participants will take KS101 or a placebo once and will stay in the study centre for a 4-night inpatient stay. Participants will return for outpatient visits on Days 8 and 29. In Part 2, participants will take KS101 twice, once after a meal and once without a meal and will stay in the study centre for a 7-night inpatient stay. Participants will return for outpatient visits on Days 11 and 32. In Part 3, participants will take KS101 or a placebo once daily for 5 days and will stay in the study centre for an 8-night inpatient stay. Participants will return for outpatient visits on Days 12 and 33.

Начало: 30.08.2025 Край: 06.08.2026 Възраст: 18–55 г. Лечение

Australia Klotho Sciences Australia Pty Ltd. NCT07143331

Активно (без набиране) Фаза 2

Study to Assess Safety and Efficacy of PRI-002 in Patients With MCI to Mild Dementia Due to Alzheimer's Disease (AD)

Mild Cognitive Impairment Due to Alzheimer's Disease Alzheimer's Disease, Early Onset

Alzheimer's disease (AD) is the most common form of dementia. In the brains of people with AD, certain small substances stick together. This leads to changes in thinking and behaviour. The company PRInnovation is developing a new treatment for Alzheimer's disease, called PRI-002. It is thought that PRI-002 can cut the sticked substances back into small pieces. That would reduce the effects of Alzheimer's disease. In the current study the investigators examine whether PRI-002 is safe and effective in participants with mild cognitive impairment (MCI) or mild dementia due to AD.

Начало: 01.12.2023 Край: 30.06.2026 Възраст: 55–80 г.

Czechia, Germany, Italy +3 PRInnovation GmbH NCT06182085

Активно (без набиране) Фаза 2/3

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation (DIAN-TU)

Alzheimers Disease Dementia Alzheimers Disease, Familial

To assess the safety, tolerability, biomarker, cognitive, and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug improves disease-related biomarkers and slows the rate of progression of cognitive or clinical impairment.

Начало: 22.12.2021 Край: 01.07.2028 Възраст: 18–80 г. Лечение

Argentina, Australia, Brazil +13 Washington University School of Medicine NCT05269394

Активно (без набиране) Фаза 3

AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid

Preclinical Alzheimer's Disease Early Preclinical Alzheimer's Disease

The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial). This study will also evaluate the long-term safety and tolerability of lecanemab in participants enrolled in the Extension Phase.

Начало: 14.07.2020 Край: 16.01.2031 Възраст: 55–80 г. Лечение

Australia, Canada, Japan +4 Eisai Inc. NCT04468659

Активно (без набиране) Фаза 2/3

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001

Alzheimers Disease Dementia Alzheimers Disease, Familial

The purpose of this study is to assess the safety, tolerability, biomarker, cognitive and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive/clinical impairment or improves disease-related biomarkers.

Начало: 01.12.2012 Край: 01.07.2028 Възраст: 18–80 г. Лечение

Argentina, Australia, Brazil +12 Washington University School of Medicine NCT01760005

Активно (без набиране) Фаза 3

A Study of Remternetug (LY3372993) in Early Alzheimer's Disease (TRAILRUNNER-ALZ 3)

Alzheimer's Disease

The purpose of this study is to measure the difference in time to developing or worsening memory, thinking, or functional problems due to Alzheimer's disease occurring in participants receiving study drug compared to placebo. Participation could last up to 255 weeks including screening, a double-blind treatment period, and a double-blind observation period. In addition, eligible participants who receive placebo during the double-blind treatment period may choose to extend their study participation to receive open-label remternetug in an extension period.

Начало: 24.10.2024 Край: 01.10.2030 Възраст: 55–80 г. Лечение

Australia, Canada, China +7 Eli Lilly and Company NCT06653153

Активно (без набиране) Фаза 2

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

Preclinical Alzheimer's Disease

The purpose of this study is to assess the effect of JNJ-64042056 on cognitive decline, as measured by Preclinical Alzheimer's disease Cognitive Composite 5 (PACC-5) compared with placebo.

Начало: 22.07.2024 Край: 16.07.2032 Възраст: 55–75 г. Лечение

Australia, Belgium, France +6 Janssen Pharmaceutica N.V., Belgium NCT06544616

Активно (без набиране) Фаза 3

DIAN-TU Amyloid Removal Trial (ART) in Dominantly Inherited Alzheimer's Disease

Alzheimer's Disease Dementia Alzheimer's Disease, Familial

This is an open label study to treat dominantly inherited Alzheimer's disease (DIAD) mutation carrier participants from the DIAN-TU-001 gantenerumab Open Label Extension (OLE) period with lecanemab to determine the effects of amyloid removal on age of onset and clinical progression compared to external controls, if amyloid plaque as measured by amyloid PET can be fully removed in DIAD, and the effects of amyloid removal on biomarkers of disease progression.

Начало: 10.06.2024 Край: 01.06.2030 Възраст: от 18 г. Лечение

Australia, United Kingdom, United States Washington University School of Medicine NCT06384573

Активно (без набиране) Фаза 2/3

Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease

Dementia Moderate Dementia, Mild Alzheimer Disease

Xanamem® is being developed as a potential treatment for symptomatic, early stages of Alzheimer's Disease (AD) and Major Depressive Disorder (MDD). This XanaMIA Phase 2b/3 study is to investigate the safety, tolerability, and efficacy of Xanamem in in mild or moderate dementia due to AD. Trial participants will be randomized to either receive 10mg of Xanamem once daily or a placebo for 36 weeks at a 1:1 ratio in a double-blinded fashion. Participants who have completed the main trial will be eligible to participate in an open-label phase, which involves treatment with 10mg Xanamem once daily for a treatment period of up to a maximum of 108 weeks. The OLE is intended to finish when all participants have completed at least 60 weeks of treatment and a follow-up visit 4 weeks later.

Начало: 12.04.2024 Край: 01.02.2028 Възраст: от 50 г. Лечение

Australia, United States Actinogen Medical NCT06125951

Активно (без набиране) Фаза 2

Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease

Alzheimer Disease, Early Onset

The purpose of this study is to assess the effectiveness, safety, and tolerability of BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's Disease.

Начало: 20.03.2024 Край: 18.03.2027 Възраст: 50–80 г. Лечение

Australia, Belgium, Canada +7 Bristol-Myers Squibb NCT06268886

Активно (без набиране) Фаза 2

Efficacy and Safety of GSK4527226 [AL101] in Participants With Early Alzheimer's Disease

Alzheimer's Disease

The aim of this study is to assess the efficacy and safety of GSK4527226 in participants with early Alzheimer's Disease (AD) (including mild cognitive impairment \[MCI\] and mild dementia due to AD) of 2 dose levels of GSK4527226 compared to placebo.

Начало: 20.10.2023 Край: 23.11.2026 Възраст: 50–85 г. Лечение

Argentina, Australia, Canada +13 GlaxoSmithKline NCT06079190

Активно (без набиране) Фаза 3

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)

Psychosis Associated With Alzheimer's Disease

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.

Начало: 28.08.2023 Край: 09.12.2026 Възраст: 55–90 г.

Belgium, Chile, China +8 Karuna Therapeutics, Inc., a Bristol Myers Squibb compa NCT06126224

Активно (без набиране)

Sleep Disturbance and Emotion Regulation Brain Dysfunction as Mechanisms of Neuropsychiatric Symptoms in Alzheimer's Dementia

Alzheimer Disease Mild Cognitive Impairment Neuropsychiatric Symptoms Sleep Disturbance

Recent findings suggest that sleep disruption may contribute to the generation and maintenance of neuropsychiatric symptoms including anxiety, depression, agitation, irritation, and apathy while treating sleep disruption reduces these symptoms. Impairments in the neural systems that support emotion regulation may represent one causal mechanism mediating the relationship between sleep and emotional distress. However, this model has not yet been formally tested within a sample of individuals with or at risk for developing Alzheimer's Disease (AD) This proposal aims to test a mechanistic model in which sleep disturbance contributes to neuropsychiatric symptoms through impairments in fronto-limbic emotion regulation function in a sample of individuals at risk for developing, or at an early stage of AD. This study seeks to delineate the causal association between sleep disruption, fronto-limbic emotion regulation brain function, and neuropsychiatric symptoms. These aims will be achieved through a mechanistic, randomized 2-arm controlled trial design. 150 adults experiencing sleep disturbances and who also have cognitive impairment with the presence of at least mild neuropsychiatric symptoms will be randomized to receive either a sleep manipulation (Cognitive Behavioral Therapy for Insomnia CBT-I; n=75) or an active control (n=75). CBT-I improves sleep patterns through a combination of sleep restriction, stimulus control, mindfulness training, cognitive therapy targeting dysfunctional beliefs about sleep, and sleep hygiene education. Neuropsychiatric symptoms, fronto-limbic functioning, and sleep disruption will be assessed at baseline and at the end of the sleep manipulation through functional Magnetic Resonance Imaging (fMRI), clinical interviews, PSG recordings, and self-report questionnaires. Neuropsychiatric symptoms (anxiety and depression) and sleep disturbance (actigraphy, Insomnia Severity Index, and sleep diaries) will be assayed at baseline and each week throughout the sleep manipulation to assess week-to-week changes following an increasing number of CBT-I sessions. Wristwatch actigraphy will be acquired from baseline to the end of the sleep manipulation at week 11. Neuropsychiatric symptoms and sleep will be assessed again at six months post-manipulation.

Начало: 31.08.2021 Край: 30.11.2026 Възраст: 50–90 г.

United States Stanford University NCT04100057

Активно (без набиране) Фаза 1/2

Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease

Alzheimers Disease

The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of multiple-ascending intravenous (IV) doses of RO7126209 in participants with prodromal or mild to moderate Alzheimer's disease (AD), who are amyloid positive based on amyloid positron emission tomography (PET) scan.

Начало: 15.03.2021 Край: 30.06.2030 Възраст: 50–85 г. Лечение

Australia, Canada, Chile +6 Hoffmann-La Roche NCT04639050

Активно (без набиране) Фаза 3

A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

Alzheimer Disease

The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease. Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab. Trial participants who were dosed with donanemab in the main study will be enrolled to a 3-year follow up addendum. No study drug will be administered during this follow up.

Начало: 19.06.2020 Край: 01.11.2028 Възраст: 60–85 г. Лечение

Australia, Canada, Czechia +6 Eli Lilly and Company NCT04437511

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