A Study of Gantenerumab in Patients with Mild Alzheimer Disease

Inclusion criteria: ‐ Adult patients, 50 to 90 years of age, inclusive ‐ Clinical diagnosis of probable mild Alzheimer disease based on NINCDS/ADRDA criteria or major NCD due to AD of mild severity, whether or not receiving AD approved medication ‐ Availability of a person ('caregiver') who in the investigator's judgment has frequent and sufficient contact with the patient, and is able to provide accurate information regarding the patient'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, doses must have been stable for at least 3 months prior to screening ‐ Agreement not to participate in other research studies for the duration of this trial and its associated substudies Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 900 Exclusion criteria: ‐ Dementia or 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 MILD ALZHEIMER’S DISEASE MedDRA version: 18.1 Level: HLT Classification code 10001897 Term: Alzheimer's disease (incl subtypes) System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] Product Name: Gantenerumab Product Code: Ro 490‐9832/F12 Pharmaceutical Form: Solution for injection in pre‐filled syringe INN or Proposed INN: gantenerumab CAS Number: n/a Current Sponsor code: RO4909832 Other descriptive name: human anti‐Aß antibody Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 105‐ Pharmaceutical form of the placebo: Solution for injection in pre‐filled syringe Route of administration of the placebo: Subcutaneous use Product Name: Gantenerumab Product Code: Ro 490‐9832/F14 Pharmaceutical Form: Solution for injection in pre‐filled syringe INN or Proposed INN: gantenerumab CAS Number: n/a Current Sponsor code: RO4909832 Other descriptive name: human anti‐Aß antibody Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 225‐ Pharmaceutical form of the placebo: Solution for injection in pre‐filled syringe Route of administration of the placebo: Subcutaneous use Product Name: Gantenerumab Product Code: Ro 490‐9832/F10 Pharmaceutical Form: Solution for injection INN or Proposed INN: gantenerumab CAS Number: n/a Current Sponsor code: RO4909832 Other descriptive name: human anti‐Aß antibody Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ Main Objective: Double‐blind treatment period (Part 1): To evaluate the efficacy of gantenerumab administered to patients by