EUCTR2011-000914-21-PL进行中（未招募）不适用
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
- 不适用
- 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 authorized 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. Subjects must not be on two acetylcholinesterase inhibitors concurrently.
- •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, vit. B12 deficiency, thyroid abnormalities).
- •2.Current residence in a skilled nursing facility.
- •3.Contraindication to undergoing MRI (e.g. pacemaker [with the exception of an MRI-compatible pacemaker], severe claustrophobia, ferromagnetic implants such as a metal plate).
- •4.Clinically signif. congestive heart failure (e.g. New York Heart Association [NYHA] Class III/IV symptoms or untreated Class II).
- •5.History of unstable angina (angina at rest) or myocardial infarction within the 12 months prior to screening.
- •6.Uncontr. hypertension defined as syst. blood pressure >160mmHg and/or diast. >100mmHg 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 syndr., protein S/protein C deficiency, AT III deficiency).
- •9.History of intracerebral hemorrhage within the 5 yrs prior to screening.
- •10.Evidence of >4 microhemorrhages (regardless of their anatom. location or diag. 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 indep. qualified central reviewer.
- •11.Head trauma with loss of consciousness, contusion, or open head injury within the 12 months prior to screening.
- •12.Uncontr. seizure disorder as defined by =2 breakthrough seizures/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 yrs 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 & stable prostate cancer not requiring treatment.
- •15.Active autoimmune/neuro-immunologic disorder.
- •16.Uncontr. major depression, psychosis, or other major psych. disorder(s).
- •17.Poorly contr. diabetes, defined as glycosylated (or glycated) hemoglobin (HbA1c) =6.5% 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 vit. B12 deficiency within 6 months prior to screening, or clinically signif. abnormally low vit. B12 at the time of screening
- •20.Abnormal clinical chemistry panel or hemat. panel meeting any one of the following criteria:
- •a.Serum alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN)
- •b.Clinically signif. 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/positive serology at screening for one/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 (<8 mg/dL).
- •23.Known history of hypersensitivity following infusions of human blood/blood components (e.g. human Ig or human albumin).
- •24.Currently receiv
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