A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER, EFFICACY AND SAFETY STUDY OF GANTENERUMAB IN PATIENTS WITH MILD ALZHEIMER’S DISEASE; PART II: OPEN-LABEL EXTENSION FOR PARTICIPATING PATIENTS

F. Hoffmann-La Roche Ltd0 个研究点目标入组 1,000 人开始时间: 2014年2月13日最近更新: 2021年6月21日

适应症

试验速览

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•- 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 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

•- 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

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