Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
50–90
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | A Study of Gantenerumab in Participants With Mild Alzheimer Disease
