A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, EFFICACY AND SAFETY STUDY OF CRENEZUMAB IN PATIENTS WITH PRODROMAL TO MILD ALZHEIMER’S DISEASE

F. HOFFMANN-LA ROCHE LTD.,0 个研究点目标入组 19 人开始时间: 2017年6月2日最近更新: 2023年9月4日

研究概览

暂无简介。

•Able to provide written consent signed by the patient
•Aged between 50 and 85 years at screening, and weight between 40 and 120 kg inclusive
•Availability of a person (referred to as the caregiver”
•Willingness and ability to complete all aspects of the study
•Adequate visual and auditory acuity
•For women/men of childbearing potential: agreement to remain total abstinent or use contraceptive method. Men should refrain from donating sperm.
•Evidence of the AD pathological process, by a positive amyloid assessment on CSF A1 42 levels.
•Demonstrated abnormal memory function at screening [FCSRT cueing index  0.67 AND free recall  27]
•Mild symptomatology, as defined by a screening MMSE score of  22 points and CDR-GS of 0.5 or 1.0. MMSE may be performed at early screening (up to 4 weeks before screening begins) or screening.
•Meets NIAAA core clinical criteria for probable AD dementia or pAD (consistent with the NIAAA diagnostic criteria and guidelines for MCI)
•If the patient is receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to screening.

•Any evidence of a disease other than AD that may affect cognition.
•History or presence of clinically evident vasculopathy that could affect the brain, stroke with clinical symptoms in the past 2 years or documented history, clinically significant CNS trauma, intracranial tumor, infections that affect brain function or history Neurological sequelae, systemic autoimmune disorders that can cause progressive neurological disease with associated cognitive deficits, schizophrenia, schizoaffective disorder, major depression, or bipolar disorder.
•At risk of suicide, according to the researcher´s opinion.
•Alcoholism and / or drug addiction.
•Evidence of MRI of a)> 2 lacunar infarcts, b) any territorial infarction> 1 cm3, or c) any white matter lesion corresponding to a general Fazekas score of 3 requiring at least 1 concomitant hypertensive lesion in the Sequence of FLAIR, having a size of ≥ 20 mm in any dimension.
•Cancer history except: if it is considered cured and if it is not actively treated with antineoplastic therapy or radiation therapy.
•Pregnancy or breastfeeding, or intention to become pregnant during the study.
•(See protocol section 4.2 for more detail).

发起方