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Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD) | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of Gantenerumab in Patients With Early (Prodromal to Mild) Alzheimer's Disease

NCT03443973•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 116. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.

Eligibility

Age

50 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical criteria for probable AD dementia or prodromal AD (consistent with the NIAAA diagnostic criteria and guidelines for mild cognitive impairment)
•Evidence of the AD pathological process, as confirmed by CSF tau/A-beta42or amyloid PET scan
•Demonstrated abnormal memory function
•MMSE score greater than or equal to 22 (≥ 22)
•Clinical dementia rating-global score (CDR-GS) of 0.5 or 1.0
•Availability of a reliable study partner who accepts to participate in study procedures throughout the 2 years duration of study
•If receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to screening and until randomization
•For enrollment in the China extension, patients must have residence in mainland China, Hong Kong, or Taiwan and be of Chinese ancestry
•For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods

Exclusion Criteria

•Any evidence of a condition other than AD that may affect cognition
•History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder
•History or presence of clinically evident systemic vascular disease that in the opinion of the investigator has the potential to affect cognitive function
•History or presence of clinically evident cerebrovascular disease
•History or presence of posterior reversible encephalopathy syndrome
•History or presence of any stroke with clinical symptoms within the past 12 months, or documented history within the last 6 months of an acute event that is consistent with a transient ischemic attack
•History of severe, clinically significant CNS trauma
•History or presence of intracranial mass (e.g., glioma, meningioma) that could potentially impair cognition
•Presence of infections that affect brain function or history of infections that resulted in neurologic sequelae
•History or presence of systemic autoimmune disorders that potentially cause progressive neurologic disease with associated cognitive deficits
+14 more criteria

Locations (155)

Banner Alzheimer?s Institute

Phoenix, Arizona, United States

Barrow Neurological Institute

Phoenix, Arizona, United States

Banner Sun Health Research Insitute

Sun City, Arizona, United States

Health Initiatives Research, PLLC

Fayetteville, Arkansas, United States

Fullerton Neurology and Headache Center

Fullerton, California, United States

Neurology Center of North Orange County

Fullerton, California, United States

Irvine Center for Clinical Research

Irvine, California, United States

Desert Valley Research

Redlands, California, United States

Southern California Research LLC

Simi Valley, California, United States

Yale University School Of Medicine

New Haven, Connecticut, United States

Key Dates

Start Date

August 22, 2018

Primary Completion Date

September 23, 2022

Completion Date

November 28, 2022

Last Updated

January 17, 2024

Enrollment

975

ACTUAL participants

Conditions

Alzheimer 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: January 17, 2024Data 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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Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)

Inclusion Criteria

Exclusion Criteria

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