A Study of Gantenerumab in Participants With Mild Alzheimer Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT02051608

Run by

Hoffmann-La Roche

People needed

389

Starts

2014-03-27

Expected to finish

2021-04-16

Last updated by the study team

2023-02-10

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Impaired hepatic function
• PET imaging substudy, in addition to above:
• Prior participation in other research study or clinical care within the last year such that the total radiation exposure would exceed the local or national annual limits
• Part 2 Participants who have been discontinued from the study

Where it is running

• 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
• University of South Florida — Tampa, Florida, United States
• Alzheimer's Research and Treatment Center — Wellington, Florida, United States
• Indiana University — Indianapolis, Indiana, United States
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
• Louisiana Research Associates — New Orleans, Louisiana, United States
• Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research — Kalamazoo, Michigan, United States
• Millennium Psychiatric Associates, LLC — St Louis, Missouri, United States
• Alzheimer's Research Corporation — Paterson, New Jersey, United States
• Ocean Rheumatology — Toms River, New Jersey, United States
• Nathan Kline Institute — Orangeburg, New York, United States
• Richmond Behavioral Associates — Staten Island, New York, United States
• Alzheimer's Memory Center — Matthews, North Carolina, United States
• Richard H Weisler, MD — Raleigh, North Carolina, United States
• Central States Research — Tulsa, Oklahoma, United States
• Abington Neurological Associates — Abington, Pennsylvania, United States
• Banner Sun Health Research Insitute — Sun City, Arizona, United States

Full record on ClinicalTrials.gov

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