MILD ALZHEIMER’S DISEASE MedDRA version: 16.1 Level: HLT Classification code 10001897 Term: Alzheimer's disease (incl subtypes) System Organ Class: 100000004852
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult patients, 50 to 90 years of age, inclusive - Clinical diagnosis of probable mild Alzheimer disease based on NINCDS/ADRDA criteria - 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 5 months prior to randomization 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
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 abuse or dependence (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the efficacy of gantenerumab compared with placebo administered to patients by SC injection over 100 weeks as measured by the following co-primary endpoints (final outcome assessment 4 weeks after the final dose): • Cognition measured by the Alzheimer’s Disease Activity Scale-Cognitive (ADAS-Cog) (13-item) • Function assessed by the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL);Secondary Objective: 1. to evaluate the benefits of gantenerumab versus placebo administered to patients by SC injection over 100 weeks on slowing clinical decline and disease progression by assessing the following: • Time to clinically evident decline • Disease pathology biomarkers 2. Additional secondary endpoints · Global: Effect on severity of dementia and global measures of cognition and function · Cognition: Effect on cognition · Behavioar: Effect on behavioral and neuropsychological symptoms of AD · Other AD symptoms and effects: Effect of gantenerumab on health-related QoL, patient-individualized goal achievement (sites in English- and French-speaking countries only), on caregiver emotional well-being, on the amount of assistance patients with dementia require in performing daily activities;Primary end point(s): Mean change in Alzheimer's Disease Activity Scale-Cognitive subscale 13 (ADAS-Cog13) scores Mean change in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scores;Timepoint(s) of evaluation of this end point: - from baseline to Week 104 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: - from baseline to Week 104 - from baseline to Week 104 - from baseline to Week 104 - from baseline to Week 104 - from baseline to Week 104 - 152 weeks ;Secondary end point(s): - Change in biomarkers (t-tau, p-tau, Abeta 1-42 levels) in cerebral spinal fluid - Change in MRI volumetry, assessed on structural MRI - Change in Clinical Dementia Rating (CDR-SB/CDR-GS) - Change in neuropsychiatric behaviour: Neuropsychiatric Inventory (NPI) total and domain scores - Change in cognition: MMSE total score - Safety: Incidence of adverse events, serious adverse events and treatment discontinuations | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Germany, Guatemala, Hungary, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Russian Federation, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd.
Outcome results
None listed