A Phase 2, Multicenter, Randomized, Parallel-Group, Double-Blind, Controlled Study of Aducanumab (BIIB037) in Subjects With Mild Cognitive Impairment due to Alzheimer’s Disease or With Mild Alzheimer’s Disease Dementia to Evaluate the Safety of Continued Dosing in Subjects with Asymptomatic Amyloid-Related Imaging Abnormalities

Biogen Idec Research Limited0 个研究点目标入组 500 人开始时间: 2018年11月9日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•Key Inclusion Criteria:
•Ability of the participant or his/her legally authorized representative to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential
•health information in accordance with national and local
•participant privacy regulations.
•Must have at least 6 years of education or work
•experience to exclude mental deficits other than MCI
•due to AD or mild AD dementia.
•Must have evidence of cerebral Aß accumulation, based on a positive PET scan of the brain. Previously obtained positron emission tomography (PET) scan
•(within 12 months of screening) is permissible. Previous PET scan images must be submitted to the central imaging vendor to confirm that study inclusion criteria
•Must consent to apolipoprotein E (ApoE) genotyping.
•Must meet all of the following clinical criteria for MCI due to AD or mild AD dementia according to NIAAA criteria [Albert 2011; McKhann 2011], and must have
•the following: MCI due to AD (a CDR global score of 0.5, and an MMSE score between 24 and 30
•(inclusive)), and Mild AD dementia (a CDR global score of 0.5 or 1, and as MMSE score between 20 and 26 (inclusive)).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•Key Exclusion Criteria:
•Any uncontrolled medical or
•neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause of the participant’s cognitive
•impairment (e.g., substance abuse, vitamin B12 deficiency, abnormal thyroid function, stroke or other cerebrovascular condition, Lewy body dementia,
•frontotemporal dementia, head trauma).
•Clinically significant unstable psychiatric illness
•(e.g., uncontrolled major depression, uncontrolled
•schizophrenia, uncontrolled bipolar affective disorder)
•within 6 months prior to Screening.
•Transient ischemic attack or stroke or any
•unexplained loss of consciousness within 1 year prior to Screening.
•Vaccinations within 10 days prior to randomization (Day 1).
•Female participants who are pregnant or currently breastfeeding.

发起方