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A Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease (AD) | Clinical Trials | Clareo Health

TERMINATEDPHASE3

A Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease (AD)

A Phase III, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease

NCT05256134•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

A study to evaluate the efficacy and safety of gantenerumab in amyloid-positive, cognitively unimpaired participants at risk for or at the earliest stages of AD. The planned number of participants for this study is approximately 1200 participants randomized in a 1:1 ratio to receive either gantenerumab or placebo (600 participants randomized to gantenerumab and 600 participants randomized to placebo).

Eligibility

Age

60 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Willing and able to comply with the study protocol and complete all aspects of the study \[including cognitive and functional assessments, physical and neurological examinations, MRI, CSF collection, genotyping, and positron emission tomography (PET) imaging\].
•Cognitively unimpaired with a screening clinical dementia rating global score (CDR-GS) of 0, and Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) \>=80.
•Evidence of cerebral amyloid accumulation.
•Participants who have an available person (referred to as a "study partner").
•Fluent in the language of the tests used at the study site.
•Adequate visual and auditory acuity, sufficient to perform neuropsychological testing (eye glasses and hearing aids are permitted).
•Agreed not to participate in other interventional research studies for the duration of this trial.
•For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 17 weeks after the final dose of study treatment.

Exclusion Criteria

•Any evidence of an underlying neurological or neurodegenerative condition that may lead to cognitive impairment other than AD.
•Clinical diagnosis of mild cognitive impairment (MCI), prodromal AD, or any form of dementia.
•History or presence of intracranial or intracerebral vascular malformations, aneurysm, subarachnoid hemorrhage, or intracerebral macrohemorrhage.
•History or presence of posterior reversible encephalopathy syndrome.
•History of ischemic stroke with clinical symptoms or an acute event that is consistent with a transient ischemic attack within 12 months of screening.
•History of severe, clinically significant (i.e., resulting in persistent neurologic deficit or structural brain damage) central nervous system (CNS) trauma (e.g., cerebral contusion).
•History or presence of intracranial mass lesion (e.g., glioma, meningioma) that could potentially impair cognition or lead to progressive neurological deficits.
•Infections that may affect brain function or a history of infections that resulted in neurologic sequelae \[e.g., human immunodeficiency virus (HIV), syphilis, neuroborreliosis, and viral or bacterial meningitis and encephalitis\].
•History of major depression, schizophrenia, schizoaffective disorder, or bipolar disorder.
•At risk for suicide.
+21 more criteria

Locations (63)

Banner Alzheimer?s Institute

Phoenix, Arizona, United States

Banner Sun Health Research Insitute

Sun City, Arizona, United States

Banner Alzheimer's Institute

Tucson, Arizona, United States

California Neuroscience Research Medical Group, Inc

Sherman Oaks, California, United States

JEM Research LLC

Atlantis, Florida, United States

Visionary Investigators Network - Neurology Aventura

Aventura, Florida, United States

Bradenton Research Center

Bradenton, Florida, United States

Brain Matters Research, Inc.

Delray Beach, Florida, United States

Neuropsychiatric Research; Center of Southwest Florida

Fort Myers, Florida, United States

ClinCloud, LLC

Maitland, Florida, United States

Key Dates

Start Date

April 19, 2022

Primary Completion Date

March 13, 2023

Completion Date

March 13, 2023

Last Updated

June 12, 2025

Enrollment

ACTUAL participants

Conditions

Alzheimers Disease

Interventions

Gantenerumab

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease (AD)

Inclusion Criteria

Exclusion Criteria

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

Screening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer's Disease Studies

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

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