EUCTR2021-001184-25-SE进行中（未招募）1 期
A PHASE III, MULTICENTER, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF GANTENERUMAB IN PARTICIPANTS AT RISK FOR OR AT THE EARLIEST STAGES OF ALZHEIMER’S DISEASE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •? Participants who:
- •- Are age 60-80 years (inclusive) at the time of signing the ICF
- •- Cognitively unimpaired with a screening Clinical Dementia Rating Global Score (CDR-GS) of 0, and Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Delayed Memory Index (DMI) >=80
- •- Show evidence of cerebral amyloid accumulation
- •- Have an available person (referred to as a study partner” throughout the protocol) who: a) Has frequent and sufficient contact with the participant, and is willing and able to provide accurate information regarding the participant’s cognitive and functional abilities, signs the necessary ICF(s), and has sufficient cognitive capacity to accurately report on the participant’s cognitive and functional abilities; b) Is in sufficiently good general health to have a high likelihood of maintaining the same level of interaction with the participant and participation in study procedures throughout the duration of the study; c) Is fluent in the language of the tests used at the study site; d) Every effort should be made to have same study partner participate throughout the duration of the study
- •- Are fluent in the language of the tests used at the study site
- •- Have adequate visual and auditory acuity, sufficient to perform neuropsychological testing
- •- Have agreed not to donate blood or blood products for transfusion for the duration of the study and for 1 year after the final dose of study drug
- •- Have agreed not to participate in other interventional research studies for the duration of this trial
- •? For women of childbearing potential:
- •- Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods during the treatment period and for at least 17 weeks after the final dose of study Treatment
- •Optional Blood-Based Biomarker Prescreening Procedure
- •? Participants who:
- •- Are age 60-80 years (inclusive) at the time of signing the Blood-Based Biomarker Prescreening Informed Consent Form (ICF)
- •- Do not have a known clinical diagnosis of cognitive impairment, MCI, prodromal AD, or any form of dementia
- •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 900
排除标准
- •Exclusions Related to central nervous system (CNS) Disorders
- •Participants who:
- •- Show any evidence of an underlying neurological or neurodegenerative condition that may lead to cognitive impairment other than AD
- •- Have a clinical diagnosis of MCI, prodromal AD, or any form of dementia
- •- Have a history or presence of intracranial or intracerebral vascular malformations, aneurysm, subarachnoid hemorrhage, intracerebral macrohemorrhage, or posterior reversible encephalopathy syndrome
- •- Have a history of ischemic stroke with clinical symptoms or an acute event that is consistent with a transient ischemic attack or severe, clinically significant CNS trauma
- •- Have a history or presence of intracranial mass lesion that could potentially impair cognition or lead to progressive neurological deficits
- •- Have infections that may affect brain function or a history of infections that resulted in neurologic sequelae
- •- Have a history of major depression, schizophrenia, schizoaffective disorder, or bipolar disorder
- •- Are at risk for suicide
- •- Have had history of alcohol and/or substance abuse or dependence
- •Exclusions Related to Imaging Findings
- •Participants who:
- •- According to the MRI central reader, show MRI evidence of any of the following:
- •* >1 lacunar infarcts
- •* Any territorial infarct >1 cm3
- •* Any white matter lesion that corresponds to an Overall
- •Fazekas score of 3
- •- Have a combined number of microbleeds and areas of leptomeningeal hemosiderosis on the MRI of >5
- •- Have a presence of any other significant cerebral abnormalities
- •- Are not able to tolerate MRI procedures or have a contraindication to MRI
- •Exclusions Related to Cardiovascular Disease
- •Participants who:
- •- Have a history or presence of clinically significant systemic vascular disease or atrial fibrillation
- •- Experienced unstable or clinically significant cardiovascular disease
- •- Have a history or presence of heart failure
- •- Have had uncontrolled hypertension
- •Exclusions Related to Hepatic and Renal Disorders
- •Participants who:
- •- Have chronic kidney disease or confirmed and unexplained impaired hepatic function
- •Exclusions Related to Infections and Immune Disorders
- •Participants who:
- •- Have a history of, or are known to currently have an HIV infection, or hepatitis B or hepatitis C virus infection or spirochete infection of the CNS
- •- Have a history or presence of systemic autoimmune disorders
- •- Have systemic immunosuppression or immunomodulation
- •- Have current COVID-19 infection
- •Exclusions Related to Metabolic and Endocrine Disorders
- •Participants who:
- •- Have abnormal thyroid function
- •- Show evidence of folic acid deficiency or vitamin B-12 deficiency
- •- Have a screening hemoglobin A1c (HbA1c) >8% or poorly controlled insulin-dependent diabetes with hypoglycemic episodes
- •Exclusions Related to Medications
- •? Any previous administration of:
- •- Gantenerumab
- •- Active immunotherapy (vaccine) that is being evaluated to prevent or postpone cognitive decline
- •- Passive immunotherapy (Ig) or other long-acting biologic agent to prevent or postpone cognitive decline
- •? Any other investigational treatment within 5 half-lives or 6 months
- •? Any previous administration of sodium oligomannate (GV-971)
- •? Any previous treatment with medications specifically intended to treat symptoms related to Parkinson’s disease or any other neurodegenerative disorder
- •? Anticonvulsant medications, typical and atypical anti-psychotic or neuroleptic medications, anticoagulation medications
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