A Study of Gantenerumab in Participants With Mild Alzheimer Disease

• Status: Completed
• Trial end date: 2021-04-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Antibodies, Monoclonal

Criteria

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

• 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