NL-OMON50277撤回3 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 - WN42444/ Skyline
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Ability to provide written informed consent and has signed the Informed
- •Consent Form
- •* Age 60-80 years old (inclusive) at time of signing the Informed Consent Form
- •* Willingness and ability to comply with the study protocol, and complete all
- •aspects of the study (including cognitive and functional assessments, physical
- •and neurological examinations, MRI, CSF collection, genotyping, and PET imaging)
- •* Cognitively unimpaired with a screening CDR-GS of 0, MoCA score 26 or > 26
- •and RBANS DMI 85 -115
- •* Evidence of cerebral amyloid accumulation, as confirmed by a combined measure
- •of quantitative and qualitative amyloid PET or CSF pTau/A(-42 ratio
- •* Availability of a person (study partner* throughout the study) in the
- •investigator's judgment
- •- Participants who are fluent in the language of the tests used at the study
- •- Participants who have adequate visual and auditory acuity, sufficient to
- •neuropsychological testing (eye glasses and hearing aids are permitted)
- •- Participants who 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
- •- Participants who have agreed not to participate in other interventional
- •studies for the duration of this trial
- •- For women of childbearing potential: agreement to remain abstinent (refrain
- •heterosexual intercourse) or use contraceptive methods that result in a failure
- •of < 1% per year during the treatment period and for at least 17 weeks after
- •dose of study treatment
排除标准
- •- Exclusions Related to CNS Disorders:
- •- Any evidence of an underlying neurological or neurodegenerative condition
- •lead to cognitive impairment other than AD, including, but not limited to,
- •frontotemporal dementia, dementia with Lewy bodies, vascular dementia,
- •Parkinson*s disease, corticobasal syndrome, Creutzfeldt-Jakob disease,
- •progressive
- •supranuclear palsy, frontotemporal lobar degeneration, Huntington disease,
- •pressure hydrocephalus, seizure disorder, delirium, hypoxia, or encephalopathy
- •related to prior COVID-19 infection
- •- Clinical diagnosis of MCI, prodromal AD, or any form of dementia
- •- History or presence of intracranial or intracerebral vascular malformations,
- •aneurysm, subarachnoid hemorrhage, or intracerebral macrohemorrhage
- •- History or presence of posterior reversible encephalopathy syndrome
- •- History of ischemic stroke with clinical symptoms or an acute event that is
- •with a transient ischemic attack within 12 months of screening
- •- History of severe, clinically significant (i.e., resulting in persistent
- •neurologic deficit
- •or structural brain damage) CNS trauma (e.g., cerebral contusion)
- •- History or presence of intracranial mass lesion (e.g., glioma, meningioma)
- •potentially impair cognition or lead to progressive neurological deficits
- •- Infections that may affect brain function or a history of infections that
- •resulted in
- •neurologic sequelae (e.g., HIV, syphilis, neuroborreliosis, and viral or
- •meningitis and encephalitis)
- •- History of major depression, schizophrenia, schizoaffective disorder, or
- •History or presence of major depression is acceptable if the participant is
- •considered to be in remission or depression is controlled by treatment and the
- •participant has had no episode of major depression within 12 months of
- •- At risk for suicide
- •- History of alcohol and/or substance abuse or dependence (according to the
- •specified in the Diagnostic and Statistical Manual of Mental Disorders, Version
- •within 2 years of screening
- •- Exclusions Related to Imaging Related Criteria
- •- Exclusions Related to Cardiovascular Disorders
- •- Exclusions Related to Hepatic and Renal Disorders
- •- Exclusions Related to Infections and Immune Disorders
- •- Exclusions Related to Metabolic and Endocrine Disorders
- •- Exclusions Related to Medications
- •- Other Exclusions
研究者
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