Alzheimer's disease clinical trials, in English

The 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.

NCT02649985 · Official ClinicalTrials.gov record · Brigham and Women's Hospital

Background: About 5 million adults in the U.S. have Alzheimer s disease or another adult-onset neurodegenerative disorder.

NCT04396873 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)

This study will look at whether nabilone is an effective treatment for agitation in Alzheimer's disease (AD) patients. Agitation is highly prevalent in patients with AD and is one of the most distressing and challenging-to-treat symptoms.

NCT04516057 · Official ClinicalTrials.gov record · Sunnybrook Health Sciences Centre

The primary objective of the Vanderbilt Alzheimer's Disease Research Center (VADRC) is to provide local and national researchers with access to a well-characterized and diverse clinical cohort, including participant referrals, biosamples, clinical data, and neuroimaging data. The VADRC Clinical Core will create an infrastructure to support research efforts of both local and national investigator studies to develop early detection, prevention, and treatment strategies for Alzheimer's disease.

NCT05372172 · Official ClinicalTrials.gov record · Vanderbilt University Medical Center

A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's Disease

NCT05925621 · Official ClinicalTrials.gov record · Beth Israel Deaconess Medical Center

The Effects of Successful OSA TreatmENT on Memory and AD BIomarkers in Older AduLts (ESSENTIAL) study is a 5-year, multicenter randomly assigned open-label trial that will screen 400 cognitively normal older adults recruited from well-established sleep clinics at 4 academic medical centers, with newly diagnosed moderate-severe OSA. An expected 200 OSA patients will be then randomly assigned to one of two groups: i) a 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an "effective" AHI4%\< 10/hour and AHI3A\<20/hour (see below); ii) a waitlist control group to receive treatment at the conclusion of the 3-month intervention period.

NCT05988385 · Official ClinicalTrials.gov record · California Pacific Medical Center Research Institute

The purpose of this research is to see how effective the Personalized obstructive sleep apnea (OSA) Treatment Adherence Model called PRAISE is in helping the patient stick to the physician recommended OSA treatment plan Positive Airway Pressure (PAP).

NCT06089161 · Official ClinicalTrials.gov record · University of Miami

This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group studies in patients with ADP * Substudy 1 (Phase 2) will evaluate how well it works and dose response of ACP-204 30 and 60 mg vs dummy treatment (placebo). * Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (ACP-204 30 and 60 mg, respectively) or a single dose from Part 1 vs dummy treatment (placebo).

NCT06159673 · Official ClinicalTrials.gov record · ACADIA Pharmaceuticals Inc.

The 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.

NCT06322667 · Official ClinicalTrials.gov record · Eisai Co., Ltd.

The goal of this clinical trial is to To demonstrate the Safety and how well it works of dcLVA Surgery for the Treatment of Alzheimer's Disease. Patients who meet the inclusion and who cannot join and consent to participate will be randomly assigned to either the experimental group (receiving dcLVA surgery plus standard medication) or the control group (receiving standard medication alone) Participants will: Undergo cognitive assessment and brain MRI assessment; Undergo a lumbar puncture; Undergo an injection of 20ml of gadodiamide contrast agent at a concentration of 0.5 mmol/L (1ml gadodiamide: 20ml 0.9% saline).

NCT06530732 · Official ClinicalTrials.gov record · Zhejiang Provincial People's Hospital

This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, compared with a dummy treatment, flexible-dose study evaluating the how well it works, safety, and tolerability of ITI-1284 compared with dummy treatment (placebo) in the treatment of psychosis in patients with AD.

NCT06540833 · Official ClinicalTrials.gov record · Intra-Cellular Therapies, Inc.

The main purpose of this study is to measure the long-term effectiveness of donanemab plus usual care versus usual care alone in participants with early symptomatic AD. The study will employ a prospective, watch-and-measure (no experimental treatment required) cohort design with participant management resembling real-world practice to the greatest extent possible via prospective assessments and linkage to historical and prospective electronic health records.

NCT06566170 · Official ClinicalTrials.gov record · Eli Lilly and Company

This study wants to measure the safety and how well it works of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.

NCT06585787 · Official ClinicalTrials.gov record · Karuna Therapeutics, Inc., a Bristol Myers Squibb company

The diagnosis of Alzheimer's disease (AD) relies on the detection of protein biomarkers, particularly in cerebrospinal fluid (e.g., Aβ and phosphorylated Tau) or through brain imaging. The invasive nature of lumbar puncture and the numerous contraindications have driven the search for early and reliable diagnostic biomarkers for AD.

NCT06661564 · Official ClinicalTrials.gov record · University Hospital, Tours

The goal of this randomly assigned clinical trial it to test the how well it works of CuidaTEXT, the first Alzheimer's disease and Related Dementias (ADRD) caregiver support intervention to capitalize on text messaging, among Latinos. Researchers will compare those who receive the CuidaTEXT intervention to those who do not receive the intervention to see if CuidaTEXT effects Latino caregiver stressors and their negative consequences .

NCT06728436 · Official ClinicalTrials.gov record · University of Kansas Medical Center

As the population increases and aging intensifies, cognitive disorders represented by Alzheimer's disease (AD) not only pose a severe threat to public health but also bring significant social and economic burdens. Previously, treatment options for Alzheimer's disease were very limited, mainly providing symptomatic relief with few available medications.

NCT06741553 · Official ClinicalTrials.gov record · Second Affiliated Hospital, Zhejiang University, School of Medicine

Alzheimer'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.

NCT06871839 · Official ClinicalTrials.gov record · Cuibai Wei，Clinical Professor

The goal of this watch-and-measure (no experimental treatment required) study is to learn about the how well it works of Lecanemab treatment for early-onset familial Alzheimer's disease (AD) in patients under 65 years of age with a family history of AD. Participants will receive Lecanemab at a dosage of 10 mg/kg every two weeks for a total of 18 months and will undergo cognitive assessments, PET and MRI scans, blood/fluid tests and whole genome sequencing.

NCT06883019 · Official ClinicalTrials.gov record · RenJi Hospital

The purpose of this research is to investigate the long-term effectiveness and safety of new Alzheimer's disease treatments, particularly monoclonal antibody therapies like lecanemab and donanemab, as well as to enhance diagnostic methods for Alzheimer's disease by collecting real-world data from Korean Alzheimer's patients. The goal is to contribute to the precision of Alzheimer's treatment and to measure the impact of these new therapies and diagnostic techniques in clinical practice.

NCT06889818 · Official ClinicalTrials.gov record · Ewha Womans University Mokdong Hospital

This randomly assigned controlled trial study aims to evaluate a revised hearing care intervention for older adults with Alzheimer's Disease and Related Dementias (ADRD). The community-delivered hearing care intervention utilizes tailored strategies to assess impact on communication, neuropsychiatric symptoms (NPS), and care partner distress.

NCT06930560 · Official ClinicalTrials.gov record · Johns Hopkins University

The goal of the Alzheimer's Tau Platform (ATP) is to measure the safety and effectiveness of tau-directed therapies, alone or in combination with the anti-amyloid monoclonal antibody, donanemab, in adults aged 50-80 with late preclinical or early prodromal Alzheimer's disease. This platform trial allows for the simultaneous testing of multiple tau therapies under a shared master protocol.

NCT06957418 · Official ClinicalTrials.gov record · Paul S. Aisen

The goal of this study is to explore the how well it works and safety of near-infrared light combined with lecanemab in patients with mild Alzheimer's disease (AD). This study will employ a randomly assigned, neither you nor the study doctors know who gets the real treatment, sham-controlled method with an open-label extension phase.

NCT06992804 · Official ClinicalTrials.gov record · Xuanwu Hospital, Beijing

The study will be conducted in 2 blinded parts (Part 1 and Part 2). In Part 1, study participants who are mutation carriers will receive active donanemab and non-mutation carriers will receive dummy treatment (placebo)-donanemab for up to 18 months (76 weeks), with a minimum treatment period of 9 months.

NCT06996730 · Official ClinicalTrials.gov record · Banner Health

This study wants to measure the how well it works and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.

NCT07011732 · Official ClinicalTrials.gov record · Bristol-Myers Squibb

The goal of this clinical trial is to investigate motor responses in healthy subjects and patients with movement disorders, brain and spinal cord injury, neuromuscular diseases, or cardiovascular diseases. This study aims to measure the effectiveness of traditional physical activities combined with innovative interventions such as cryotherapy, ultrasound therapy, laser therapy, transcranial magnetic stimulation (TMS), and transcranial direct current stimulation (tDCS).

NCT07066137 · Official ClinicalTrials.gov record · IRCCS Centro Neurolesi Bonino Pulejo

The goal of this watch-and-measure (no experimental treatment required) study is to valuate the sensitivity and specificity of different blood biomarkers for monitoring and assessing Aβ-PET-confirmed mitigation of amyloid pathology by lencanumab treatment in subjects treated with lencanumab.

NCT07153848 · Official ClinicalTrials.gov record · First Affiliated Hospital of Zhejiang University

Background: About 5 million adults in the United States have age-related brain disorders. These include Alzheimer disease (AD), mild cognitive impairment (MCI), and other dementias.

NCT07169630 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)

The goal of this international watch-and-measure (no experimental treatment required) study is to evaluate long-term disease outcomes and treatment safety in people with Alzheimer's disease (PwAD), by collecting real-world data from routine clinical practice across global clinical centers. The InRAD Registry watch-and-measure (no experimental treatment required) Study has several aims: * To collect medical information for many years from a large group of people with Alzheimer's disease.

NCT07213700 · Official ClinicalTrials.gov record · Stichting International Registry for Alzheimer's Disease and other Dementias Foundation

Trial to measure the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ARO-MAPT-SC compared to dummy treatment (placebo) in adult healthy volunteers and in participants with early Alzheimer's disease (AD), defined as mild cognitive impairment due to AD and mild AD dementia, as well as primary tauopathies, including microtubule associated protein tau -related frontotemporal dementia (MAPT-FTD) and progressive supranuclear palsy- Richardson syndrome (PSP-RS).

NCT07221344 · Official ClinicalTrials.gov record · Arrowhead Pharmaceuticals

The goal of this clinical trial is to measure the safety and how well it works of EXV-802 and EXV-801 in treatment of agitation in participants with Alzheimer's Disease dementia.

NCT07284472 · Official ClinicalTrials.gov record · Exciva GmbH

This study is being conducted to understand changes in brain activity following administration of two different drugs (Psilocybin and Dextromethorphan) in older adults with low well-being. The main questions it aims to answer are, does psilocybin: 1.

NCT07386730 · Official ClinicalTrials.gov record · Jennifer Mitchell

Persons living with dementia (PLWD) are at significantly increased risk for falls, which are the leading cause of emergency department (ED) visits in this population and contribute to serious injuries, functional decline, and caregiver burden. GAPcareAD is an ED-initiated, caregiver-inclusive intervention designed to address fall risk at the point of care.

NCT07563270 · Official ClinicalTrials.gov record · University of Colorado, Denver

The goal of this prospective, multicenter, watch-and-measure (no experimental treatment required) cohort study is to measure the screening performance of blood-based biomarkers for Alzheimer's disease (AD) in a real-world community screening setting, and to establish the population baseline levels and reference intervals of these biomarkers in Chinese older adults. The main questions it aims to answer is: What is the clinical screening value of blood biomarkers (phosphorylated tau 217 to amyloid β 42 ratio \[pTau217/Aβ42\] and glial fibrillary acidic protein \[GFAP\]) for AD among community-dwelling older adults?

NCT07570719 · Official ClinicalTrials.gov record · Kuang XiaoJun

The main purpose of this study is to measure the effects of donanemab (LY3002813) versus dummy treatment (placebo) in Chinese participants who are at risk for decline of memory, language and physical ability to perform activities of daily living from Alzheimer's disease (AD). The study drug will be administered intravenously (IV) (into a vein in the arm).

NCT07571161 · Official ClinicalTrials.gov record · Eli Lilly and Company

The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.

NCT07589595 · Official ClinicalTrials.gov record · Eli Lilly and Company

This study wants to see how LY3439539 affects certain proteins found in the spinal fluid of participants with Alzheimer's disease. Participation in the study will last approximately 9 months with visits about once a month.

NCT07598370 · Official ClinicalTrials.gov record · Eli Lilly and Company

The 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.

NCT07602582 · Official ClinicalTrials.gov record · Eli Lilly and Company

This research proposal outlines a multi-center, randomly assigned, trial. Patients diagnosed with early-to-moderate Alzheimer's Disease will be recruited.

NCT07604896 · Official ClinicalTrials.gov record · First Affiliated Hospital of Wenzhou Medical University

Alzheimer's disease (AD) is the most common cause of dementia. Despite major research efforts, effective treatments that slow or stop disease progression remain limited.

NCT07651319 · Official ClinicalTrials.gov record · The Methodist Hospital Research Institute

This is a randomly assigned, compared with a dummy treatment Phase 2 study to measure the how well it works and safety of SAR448851 in early Alzheimer's disease (AD) participants. this study wants to measure how well it works and safety with once daily oral SAR448851 compared to dummy treatment (placebo) in participants with mild cognitive impairment due to AD or mild AD dementia and with evidence of cerebral amyloid pathology.

NCT07688213 · Official ClinicalTrials.gov record · Sanofi

This study aims to measure the therapeutic how well it works of Lecanemab in patients with Alzheimer's disease. The researchers will use a novel detection method based on mesoporous gold electrode surface-enhanced electrochemiluminescence (ECL) to monitor specific biomarkers in the patients' plasma.

NCT07688460 · Official ClinicalTrials.gov record · The Fourth Affiliated Hospital of Zhejiang University School of Medicine

This study will measure the how well it works and safety of trontinemab in participants with biomarker evidence of Alzheimer's Disease (AD) pathology but with no cognitive or functional impairment, who are at risk for progression to mild cognitive impairment (MCI) due to AD or dementia due to AD.

NCT07717411 · Official ClinicalTrials.gov record · Hoffmann-La Roche

Background: Normal aging, as well as dementias such as Alzheimer s disease, can cause changes in the brain that affect memory, attention, and thinking. Researchers want to know if regular mental tasks (cognitive training) can improve brain function in older adults.

NCT07721467 · Official ClinicalTrials.gov record · National Institute on Aging (NIA)

To describe the incidence and severity of known side effects, including amyloid-related imaging abnormalities-edema (ARIA-E), ARIA microhemorrhage and hemosiderin deposit (ARIA-H), and intracerebral hemorrhage greater than 1 cm in diameter in participants treated with LEQEMBI during routine clinical practice, summarizing the data overall and by apolipoprotein E4 variant (APOE4) genotype, concomitant antithrombotic therapy, and baseline magnetic resonance imaging (MRI) findings (comorbid cerebral amyloid angiopathy \[CAA\]). The secondary purpose of this study is, To describe progression to the next stage of Alzheimer's Disease (AD), stratified by ARIA and intracerebral hemorrhage greater than 1 cm.

NCT07762092 · Official ClinicalTrials.gov record · Eisai Limited

This study aims to compare the effects of RO7568282 versus a dummy treatment (placebo) in people in the early stages of Alzheimer's disease (AD).

NCT07781657 · Official ClinicalTrials.gov record · Hoffmann-La Roche

The purpose of this Master Protocol is to support multiple studies looking at whether it is safe and how hard side effects are to live with of different drugs in healthy participants and participants with Alzheimer's disease, and if they remove clumps of protein (amyloid plaque) in the brain in participants with Alzheimer's Disease. Participants will enroll into either A1D-MC-AT01 (NCT07787182) or A1D-MC-AT02 (upcoming).

NCT07787169 · Official ClinicalTrials.gov record · Eli Lilly and Company

The primary purpose of this study is to measure the safety of lecanemab-irmb 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 cm in participants treated with lecanemab-irmb. The secondary purpose of this study is to: measure the safety of lecanemab-irmb in the real-world clinical setting as reported by events of seizures, anaphylaxis, central nervous system (CNS) ischemic event, and death.

NCT07821658 · Official ClinicalTrials.gov record · Eisai Inc.

The aim of the study is to measure the clinical and biological how well it works, as well as predictors of how well it works, of a home-based intervention combining transcranial alternating current stimulation (tACS) with individualized computerized cognitive training in patients with mild Alzheimer's disease (AD). In neurodegenerative diseases, including AD, neurodegeneration is accompanied by alterations in brain oscillatory activity.

NCT07839650 · Official ClinicalTrials.gov record · IRCCS Centro San Giovanni di Dio Fatebenefratelli

The goal of this clinical trial is to learn if a wearable ultrasound device, called ATTN201, is safe and easy to use. The study is for adults ages 65 and older who have mild cognitive impairment (MCI) and a buildup of a protein called amyloid in the brain.

NCT07866768 · Official ClinicalTrials.gov record · University of California, San Francisco

VIZAMYL (flutemetamol F 18 injection) is a drug used during Positron Emission Tomography (PET) brain scans. It helps doctors detect the presence of amyloid protein, which is associated with Alzheimer's disease and other conditions affecting memory or thinking.

NCT07873463 · Official ClinicalTrials.gov record · GE Healthcare

This multicenter study aims to characterize the language profiles of patients with various neurodegenerative diseases, including Alzheimer's disease (AD), Primary Progressive Aphasia (PPA), behavioral variant Frontotemporal Dementia (bvFTD), Dementia with Lewy Bodies (DLB), and Parkinson's disease (PD), using artificial intelligence (AI) models. By analyzing speech and language data collected during remote neuropsychological assessments, the researchers intend to identify objective linguistic biomarkers suitable for early and differential diagnosis, overcoming the limitations of traditional, invasive, and costly diagnostic tools.

NCT07906769 · Official ClinicalTrials.gov record · Istituti Clinici Scientifici Maugeri SpA

The I-FACE project aims to develop and validate a battery to assess famous-face recognition in people with neurodegenerative diseases and stroke. It will examine face naming, familiarity, and semantic knowledge, establish norms for the Italian population, and test how well the measures identify recognition difficulties in patients with frontotemporal dementia, Alzheimer's disease, and stroke.

NCT07911878 · Official ClinicalTrials.gov record · Istituti Clinici Scientifici Maugeri SpA

The goal of this multicenter retrospective watch-and-measure (no experimental treatment required) study is to learn about the real-world safety and clinical effectiveness of disease-modifying therapy (DMT) in adults with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or AD dementia. The main questions it aims to answer are: What are the safety outcomes of DMT, including amyloid-related imaging abnormalities (ARIA), side effects, and infusion reactions (IRRs)?

NCT07923812 · Official ClinicalTrials.gov record · Fudan University

This summary focuses on the acoustic stimulation part of the study. The goal of this treatment study is to learn if acoustic stimulation during sleep works to improve cognitive function in patients with Alzheimer's disease.

NCT07924657 · Official ClinicalTrials.gov record · Xuanwu Hospital, Beijing