a study of gantenerumab in participants with mild alzheimer disease

Conditions: Alzheimer's Disease

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 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