EUCTR2012-003242-33-ES进行中（未招募）1 期
A MULTICENTER, OPEN-LABEL, LONG-TERM SAFETY EXTENSION OF PHASE II STUDIES ABE4869g AND ABE4955g IN PATIENTS WITH MILD TO MODERATE ALZHEIMER?S DISEASE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 350
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
- •? Ability to provide written informed consent by the patient or the patient?s authorized representative under applicable local law
- •? Ability and willingness of the patient to comply with the protocol?s requirements
- •? Previous participation in Study ABE4869g or ABE4955g and completion of the Week 73 visit
- •? Patients who discontinued from study treatment or from the study prior to completion of the Week 73 visit are not eligible.
- •? Adequate visual and auditory acuity, in the investigator's judgment, to allow for neuropsychological testing
- •? Availability of a person (caregiver) who can provide information on activities of daily living and behavior in order to complete the study-specific assessments
- •? This caregiver must have sufficient cognitive capacity, in the judgment of the investigator, to accurately report upon the patient's function and behavior. In addition, the caregiver must spend sufficient time with the patient to be familiar with the overall function and behavior of the patient. As guidance, a caregiver would ordinarily need to spend an average of at least 8 hours per week with the patient in order for the caregiver to meet the requirements for this study.
- •? Diagnosis of probable Alzheimer?s disease according to the National Institute on Neurological and Communication Disease and Stroke/Alzheimer?s Disease and Related Disorders Association (NINCDS-ADRDA) criteria (McKhann et al. 1984)
- •? MMSE score of 12 or more at screening (Folstein et al. 1975)
- •? For male patients with partners with reproductive potential, agreement to use a reliable means of contraception (e.g., condoms) during the study
- •? For female patients, a negative serum ?-human chorionic gonadotropin (?-hCG) pregnancy test at screening
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 280
排除标准
- •? Early treatment and/or study discontinuation prior to completion of the Week 73 visit of Genentech Study ABE4869g or ABE4955g
- •? Inability to tolerate MRI procedures or contraindication to MRI, including but not limited to pacemakers; implantable cardioverter defibrillators; cochlear implants; cerebral aneurysm clips; implanted infusion pumps; implanted nerve stimulators; metallic splinters in the eye; other magnetic, electronic, or mechanical implants; or any other clinical history or examination finding that, in the judgment of the investigator, would pose a potential hazard in combination with MRI
- •? Female patient with reproductive potential: Female patients must either have undergone documented surgical sterilization or have not experienced menstruation for at least 12 consecutive months.
- •? Severe or unstable medical condition that, in the opinion of the investigator or Sponsor, would interfere with the patient's ability to complete the study assessments or would require the equivalent of institutional or hospital care
- •? History or presence of clinically evident vascular disease potentially affecting the brain (e.g., stroke, clinically significant carotid or vertebral stenosis or plaque, aortic aneurysm, intracranial aneurysm, cerebral hemorrhage, arteriovenous malformation)
- •? History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system trauma (e.g., cerebral contusion)
- •? History or presence of clinically relevant intracranial tumor (e.g., meningioma, glioma)
- •? Presence of infections that affect the brain function or history of infections that resulted in neurologic sequelae (e.g., syphilis, neuroborreliosis, viral or bacterial meningitis/encephalitis, HIV encephalopathy)
- •? History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., multiple sclerosis, lupus erythematosus, anti-phospholipid antibody syndrome, Behçet disease)
- •? History or presence of a neurologic disease other than Alzheimer?s disease that may affect cognition, including but not limited to Parkinson?s disease, corticobasal degeneration, dementia with Lewy bodies, Creutzfeldt?Jakob disease, progressive supranuclear palsy, frontotemporal degeneration, Huntington?s disease, normal pressure hydrocephalus, and hypoxia
- •? History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
- •? Evidence of malignancies (except squamous cell cancer or basal cell cancer of the skin), acute infections, renal failure that requires dialysis, or other unstable medical disease not related to Alzheimer?s disease that, in the investigator?s opinion, would preclude patient participation
- •? Cancer that is not being actively treated with anti-cancer therapy or radiotherapy as well as cancers that are considered to have low probability of recurrence (with supporting documentation from the treating oncologist if possible) are allowed
- •? History or presence of atrial fibrillation that, in the investigator?s judgment, poses a risk for future stroke
- •? Chronic kidney disease of Stage ? 4, according to the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF KDOQI) guidelines for chronic kidney disease (CKD)
- •? Impaired hepatic function, as indicated by transaminases > 2 times the upper limit of normal (ULN) or abnormalities in synthetic function tests judged by the investigato
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