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Phase 3 Alzheimers Disease Trials

9 Phase 3 trials for Alzheimers Disease. Phase 3 trials are the final stage of testing before a treatment can be submitted for FDA approval.

What is a Phase 3 trial?

Phase 3 clinical trials study a treatment in large groups (hundreds to thousands of people) to confirm its effectiveness, monitor side effects, and compare it to standard treatments. These trials are the last major step before the FDA considers approving a new treatment.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.
RECRUITINGPhase 3NCT07011732

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With...

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.

Sponsor: Bristol-Myers SquibbEnrolling: 35220 locations
RECRUITINGPhase 3NCT07170150

A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease

The 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...

Sponsor: Hoffmann-La RocheEnrolling: 80020 locations
RECRUITINGPhase 3NCT05980949

Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis...

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...

Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb companyEnrolling: 80020 locations
RECRUITINGPhase 3NCT07234695

LEvetiracetam to Prevent Seizures in Symptomatic Alzheimer's Disease in Adults With Down Syndrome

The purpose of this study is to evaluate whether levetiracetam can prevent epileptic seizures in patients with Alzheimer's disease associated with Down syndrome. It will also...

Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauEnrolling: 1205 locations
RECRUITINGPhase 3NCT07142954

Epidemiology and Biomarker Study in Alzheimer's Disease

Study AACU determines rates of cognitive worsening in participants within elevated and not elevated plasma P-tau217 cohorts. Participation in AACU will last approximately 7 years.

Sponsor: Eli Lilly and CompanyEnrolling: 34003 locations
RECRUITINGPhase 3NCT06976216

A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease

Sponsor: Bristol-Myers SquibbEnrolling: 58620 locations
RECRUITINGPhase 3NCT05508789

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

Sponsor: Eli Lilly and CompanyEnrolling: 150020 locations
RECRUITINGPhase 3NCT06702124

A Phase 3 Study of Rotigotine in Combination with Rivastigmine in Mild to Moderate Alzheimer's Disease

This is a 24-week prospective, randomized, double-blind, placebo-controlled, multi-center phase III study evaluating efficacy and safety of rotigotine 4mg/24 hrs in combination...

Sponsor: I.R.C.C.S. Fondazione Santa LuciaEnrolling: 3481 location
RECRUITINGPhase 3NCT06937229

A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)

The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule...

Sponsor: Bristol-Myers SquibbEnrolling: 60020 locations