EUCTR2011-000914-21-DE进行中（未招募）1 期
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFECTIVENESS OF IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% SOLUTION (IGIV, 10%) FOR THE TREATMENT OF MILD TO MODERATE ALZHEIMER’S DISEASE (AD) - Phase 3 IGIV, 10% in AD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 402
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
- •1.Males or females of age 50 to 89 years inclusive at the time of screening.
- •2.Written informed consent obtained from either the subject or the subject’s legally acceptable representative prior to any study-related procedures.
- •3.Written informed consent obtained from an able and competent caregiver who is willing to comply with the requirements of the protocol pertaining to him/her, including facilitating the subject’s participation in the study.
- •4.Diagnosis of Probable AD according to National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) 1984 criteria.
- •5.Dementia of mild to moderate severity (MMSE 16-26 inclusive at the time of screening).
- •6.Neuroimaging (computed tomography [CT] or MRI) performed after symptom onset consistent with AD diagnosis.
- •7.Willingness to comply with the requirements of the protocol and ability to comply with testing and infusion regimen, including adequate corrected visual acuity and hearing ability.
- •8.For at least 12 weeks prior to screening, on stable doses of AD medication(s) approved by local regulatory authorities.
- •9.Venous access for repeated infusion and phlebotomy.
- •10.If receiving psychoactive medications (e.g., antidepressants other than monoamine oxidase inhibitors [MAOIs] and most tricyclics, antipsychotics, anxiolytics, anticonvulsants, mood stabilizers, etc.), must be on stable doses for at least 6 weeks prior to screening.
- •11.For women of childbearing potential, the subject must have a negative pregnancy test at screening and must agree to employ adequate contraceptive measures (e.g. birth control pills/patches, intrauterine device, or diaphragm or condom [for male partner] with spermicidal jelly or foam) throughout the course of the study.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 302
排除标准
- •1.Possible AD by NINCDS-ADRDA criteria or non-Alzheimer dementia (e.g. vascular dementia, dementia with Lewy bodies, frontotemporal dementia, or dementia arising from other diseases or conditions such as Parkinson’s disease, vitamin B12 deficiency, thyroid abnormalities).
- •2.Current residence in a skilled nursing facility.
- •3.Contraindication to undergoing MRI (e.g. pacemaker, severe claustrophobia, ferromagnetic implants such as a metal plate).
- •4.Clinically significant congestive heart failure (e.g. New York Heart Association [NYHA] Class III/IV symptoms or untreated Class II).
- •5.History of unstable angina or myocardial infarction within the 12 months prior to screening.
- •6.Uncontrolled hypertension defined as systolic blood pressure > 160 mm Hg and/or diastolic > 100 mm Hg confirmed upon repeated measures.
- •7.History of thrombosis and/or thromboembolic disease (central or peripheral) within the 12 months prior to screening.
- •8.Known history of procoagulant abnormalities (e.g. factor V Leiden, antiphospholipid syndrome, protein S/protein C deficiency, AT III deficiency).
- •9.History of intracerebral hemorrhage within the 5 years prior to screening.
- •10.Evidence of greater than 4 microhemorrhages (regardless of their anatomical location or diagnostic characterization as possible” or definite”), a single area of superficial siderosis, a macrohemorrhage, major stroke, or multiple lacunae by a recent (within 3 months prior to screening) and/or the baseline MRI, as confirmed by an independent qualified central reviewer.
- •11.Head trauma with loss of consciousness, contusion, or open head injury within the 12 months prior to screening.
- •12.Uncontrolled seizure disorder as defined by two or more breakthrough seizures per year despite adequate antiepileptic drug (AED) treatment.
- •13.Modified Hachinski score > 4 at time of screening.
- •14.Subjects with active malignancy or history of malignancy within 5 years prior to screening with the exception of the following: adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and stable prostate cancer not requiring treatment.
- •15.Active autoimmune or neuro-immunologic disorder.
- •16.Untreated major depression, psychosis, or other major psychiatric disorder(s).
- •17.Poorly controlled diabetes, defined as glycosylated (or glycated) hemoglobin (HbA1c) = 6.5% for subjects with abnormal fasting glucose at screening.
- •18.Creatinine clearance < 50% of normal adjusted for age and gender, as calculated according to the Cockcroft-Gault formula, at the time of screening.
- •19. Known history of untreated vitamin B12 deficiency within 6 months prior to screening, or clinically significant abnormally low vitamin B12 at the time of screening
- •20.Abnormal clinical chemistry panel or hematology panel meeting any one of the following criteria:
- •a.Serum alanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN)
- •b.Clinically significant anemia that precludes repeated blood sampling or hemoglobin (Hgb) < 10.0 g/dL
- •c.Absolute neutrophil count (ANC) < 1000 cells/µL
- •d.Known coagulopathy or platelet counts < 100,000 cells/µL
- •e.Total serum protein > 9 g/dL
- •21.Known history of or positive serology at screening for one or more of the following: hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) type 1/2 antibody.
- •22.Immunoglobulin A (IgA) deficiency (< 7 mg/dL).
- •23.Known history of hypersensitivity follo
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