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A Study of Gantenerumab in Participants With Mild Alzheimer Disease | Clinical Trials | Clareo Health

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A Study of Gantenerumab in Participants With Mild Alzheimer Disease

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Gantenerumab in Patients With Mild Alzheimer's Disease; Part II: Open-Label Extension For Participating Patients

NCT02051608•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer disease. Participants will be randomized to receive either gantenerumab subcutaneously every 4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if on stable dose for 3 months prior to screening. Part 2 is an open-label extension (OLE). A positron emission tomography (PET) imaging substudy will be conducted within the main study. Eligible participants who provide separate informed consent will undergo PET imaging scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain amyloid load over time.

Eligibility

Age

50 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Clinical diagnosis of probable mild Alzheimer disease (AD) based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria or major NCD based whether or not receiving AD approved medication
•Cerebral spinal fluid (CSF) result consistent with the presence of amyloid pathology
•Availability of a person ('caregiver') who in the investigator's judgment has frequent and sufficient contact with the participant, and is able to provide accurate information regarding the participant's cognitive and functional abilities
•Fluency in the language of the tests used at the study site
•Willingness and ability to complete all aspects of the study
•Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)
•If currently receiving approved medications for AD, the dosing regimen must have been stable for 3 months prior to screening
•Agreement not to participate in other research studies for the duration of this trial and its associated substudies
•PART 2 - All participants who have been randomized and are actively participating in the study are eligible for Part 2

Exclusion Criteria

•Dementia or neurocognitive disorder (NCD) due to a condition other than AD, including, but not limited to, frontotemporal dementia, Parkinson disease, dementia with Lewy bodies, Huntington disease, or vascular dementia
•History or presence of clinically evident vascular disease potentially affecting the brain that in the opinion of the investigator has the potential to affect cognitive function
•History or presence of stroke within the past 2 years or documented history of transient ischemic attack within the last 12 months
•History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease with associated cognitive deficits
•History of schizophrenia, schizoaffective disorder, or bipolar disorder
•Alcohol and/or substance use disorder (according to the DSM-5) within the past 2 years (nicotine use is allowed)
•History or presence of atrial fibrillation
•Within the last 2 years, unstable or clinically significant cardiovascular disease (e.g., myocardial infarction, angina pectoris, cardiac failure New York Heart Association Class II or higher)
•Uncontrolled hypertension
•Chronic kidney disease
+4 more criteria

Locations (131)

Banner Sun Health Research Insitute

Sun City, Arizona, United States

Territory Neurology and Research Institute

Tucson, Arizona, United States

ATP Clinical Research, Inc

Costa Mesa, California, United States

Pacific Research Network - PRN

San Diego, California, United States

California Neuroscience Research Medical Group, Inc

Sherman Oaks, California, United States

Meridien Research

Brooksville, Florida, United States

Brain Matters Research, Inc.

Delray Beach, Florida, United States

Neuropsychiatric Research; Center of Southwest Florida

Fort Myers, Florida, United States

Miami Jewish Health Systems; Clinical Research

Miami, Florida, United States

Accelerated Enrollment Solutions

Orlando, Florida, United States

Key Dates

Start Date

March 27, 2014

Primary Completion Date

April 16, 2021

Completion Date

April 16, 2021

Last Updated

February 10, 2023

Enrollment

389

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

Placebo

DRUG

Gantenerumab

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

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: February 10, 2023Data 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 of Gantenerumab in Participants With Mild Alzheimer Disease

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

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