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 Human Mesenchymal Stem Cells & Monoclonal Antibodies in the Treatment for Mild Cognitive Impairment or Early Alzheimer's Disease.
NCT07512362 · Mild Cognitive Impairment,
Early Alzheimer's Disease, AD-MCI
RecruitingThe purpose of this study is to test if adding one infusion of (Human Mesenchymal Stem Cells) hMSCs to the treatment with standard of care (SOC) monoclonal antibodies (mAb) will stabilize the rate of cognitive and functional decline associated with mild Alzheimer's Disease.
PhasePhase 2
TypeInterventional
Age55 Years – 90 Years
WhereMiami, Florida, United States
SponsorBernard (Barry) Baumel
▾Tap for detailsClick for full details — eligibility, all locations, contacts ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease
RecruitingThe purpose of this study is to evaluate the safety and efficacy of the ExAblate Model 4000 Type 2.0 System as a tool to disrupt the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).
PhaseNA
TypeInterventional
Age50 Years – 85 Years
WhereDelray Beach, Florida, United States + 9 more
SponsorInSightec
▾Tap for detailsClick for full details — eligibility, all locations, contacts Human Mesenchymal Stem Cells (hMSC) in Behavioral Problems Due to Alzheimer's Disease.
NCT06781333 ·
Alzheimer Disease, Agitation in Dementia
RecruitingThe purpose of this research study is to test if adding one infusion of mesenchymal stem cells to the current treatment with antipsychotic medication may help control behavioral problems in people with a diagnosis of moderate to severe Alzheimer's disease.
PhasePhase 2
TypeInterventional
Age55 Years – 90 Years
WhereMiami, Florida, United States
SponsorBernard (Barry) Baumel
▾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 Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type
NCT06052254 · Agitation
RecruitingThe primary objective of this study is to evaluate the efficacy of DMTS on frequency and severity of agitation associated with dementia of the Alzheimer's type, compared with placebo.
PhasePhase 2
TypeInterventional
AgeAny
WhereDaytona Beach, Florida, United States + 5 more
SponsorTeikoku Pharma USA, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Development of a Database to Investigate Digital and Blood-Based Biomarkers and Their Relationship to Tau and Amyloid PET Imaging in Older Participants Who Are Cognitively Normal (CN), Have Mild Cognitive Impairment (MCI), or Have Mild-to-Moderate AD Dementia
RecruitingBio-Hermes-002 is a 120-day cross-sectional study that will result in a blood, CSF, retinal, digital, MRI, and PET brain imaging biomarker database that can be used to determine the primary objective. Digital biomarkers and blood-based biomarkers will be tested to determine whether a meaningful relationship exists between biomarkers alone or in combination with tau or amyloid brain pathology identified through PET images.
Phase—
TypeObservational
Age60 Years – 90 Years
WhereAtlantis, Florida, United States + 25 more
SponsorGAP Innovations, PBC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Clinical Trial on Agitation in Alzheimer's Dementia
NCT05543681 ·
Alzheimer Disease, Agitation,Psychomotor, Care Giving Burden
RecruitingThe purpose of this study is to assess the efficacy of the oral medication IGC-AD1, a THC-based (Delta-9-Tetrahydrocannabinol) formulation administered twice a day on Agitation in patients with mild to severe dementia from Alzheimer's.
PhasePhase 2
TypeInterventional
Age60 Years
WhereMaitland, Florida, United States + 30 more
SponsorIGC Pharma, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Screening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer's Disease Studies
RecruitingThis study is a pre-screening process used to assess participants' potential eligibility for Roche interventional Alzheimer's disease studies.
PhasePhase 3
TypeInterventional
Age50 Years – 90 Years
WhereBirmingham, Alabama, United States + 210 more
SponsorHoffmann-La Roche
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
RecruitingThe purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.
PhasePhase 3
TypeInterventional
Age55 Years – 90 Years
WhereChandler, Arizona, United States + 291 more
SponsorKaruna Therapeutics, Inc., a Bristol Myers Squibb company
▾Tap for detailsClick for full details — eligibility, all locations, contacts Alzheimer's Disease Treatment With Combination of 40Hz Light and Cognitive Therapy
NCT03657745 ·
Alzheimer Disease, Mild Cognitive Impairment, Dementia
RecruitingElectrical activity in the brain known as "gamma" brainwaves help connect and process information throughout the brain. These gamma waves are diminished in Alzheimer's disease. New research in Alzheimer's disease mouse models shows that exposure to light flickering at the rate of 40 flashes per second or 40Hz increased gamma brainwaves and led to clearing of beta amyloid plaques in the brain, a key abnormality in Alzheimer's disease. This project will test the ability of a novel iPad App (AlzLife https://www.alz.life/) that delivers light therapy at 40 Hz combined with cognitive therapy to improve cognition, function, and quality of life in Alzheimer's disease.
Phase—
TypeObservational
Age50 Years
WhereMiami, Florida, United States
SponsorAlzheimer's Light LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type
NCT05397639 · Agitation, Alzheimer's Type Dementia
RecruitingThis study will be conducted to evaluate the efficacy, safety, tolerability, and pharmacokinetics of masupirdine compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.
PhasePhase 3
TypeInterventional
Age50 Years – 90 Years
WhereAnaheim, California, United States + 43 more
SponsorSuven Life Sciences Limited
▾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 Late Onset Alzheimer's Disease
RecruitingThe goal of this study is to is to focus on the genetic influences on Alzheimer's Disease (AD) risk. The investigators are looking for families and/or individuals (affected or unaffected) of any ethic background (African American, Caucasian, and Hispanics) with a family history of AD and willing to participate.
Phase—
TypeObservational
Age55 Years
WhereWashington D.C., District of Columbia, United States + 11 more
SponsorColumbia University
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)
RecruitingThis is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease. The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason or relapse and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.
PhasePhase 3
TypeInterventional
Age55 Years – 90 Years
WhereHomewood, Alabama, United States + 128 more
SponsorKaruna Therapeutics, Inc., a Bristol Myers Squibb company
▾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 A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)
RecruitingThis 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.
PhasePhase 3
TypeInterventional
Age55 Years – 90 Years
WhereChandler, Arizona, United States + 153 more
SponsorKaruna Therapeutics, Inc., a Bristol Myers Squibb company
▾Tap for detailsClick for full details — eligibility, all locations, contacts ACP-204 in Adults With Alzheimer's Disease Psychosis
RecruitingThis is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP * Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first. * 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 placebo. Substudies 2A and 2B will be performed independently of each other and will commence after enrollment of Part 1. All 3 substudies will be analyzed independently of each other. Each substudy individually will consist of a screening period (up to 49 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).
PhasePhase 2 / Phase 3
TypeInterventional
Age55 Years – 95 Years
WhereChandler, Arizona, United States + 144 more
SponsorACADIA Pharmaceuticals Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Personalized Obstructive Sleep Apnea Treatment and Effects on Alzheimer's Disease Biomarkers and Cognition Among Blacks
NCT06089161 · Sleep Apnea
RecruitingThe 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).
PhaseNA
TypeInterventional
Age60 Years – 85 Years
WhereMiami, Florida, United States
SponsorUniversity of Miami
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
NCT07589595 · Cognitive Dysfunction, Lewy Body Disease, Synucleinopathies
RecruitingThe 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.
PhasePhase 2
TypeInterventional
Age55 Years – 85 Years
WhereChandler, Arizona, United States + 71 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts