A Randomized, Double-Blind, Placebo-Controlled, Two Dose Arm, Parallel Study of the Safety and Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 390
- 试验地点
- 40
- 主要终点
- Change From Baseline at 18 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of 2 doses of Immune Globulin Intravenous (IGIV), 10% administered every 2 weeks as an intravenous (IV) infusion compared with placebo in participants with mild to moderate Alzheimer's disease (AD).
详细描述
Study visits: Each participant will be tested at the investigational site, and if qualified, will be treated intravenously (through a vein) every two weeks for 70 weeks (approximately 18 months). The first three infusions must be done at the site, but if the infusions are well tolerated, subsequent infusions may be done by a qualified healthcare provider in the home or other suitable location. Each participant must return to the site every 3 months for evaluation of cognition as well as blood tests and scans of the brain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Written informed consent - participant (or participant´s legally acceptable representative) and caregiver who are willing and able to participate for the duration of the study
- •Diagnosis of probable Alzheimer´s Disease (AD)
- •Dementia of mild to moderate severity defined as mini-mental state examination (MMSE) 16-26 inclusive at the time of screening
- •Neuroimaging (computed tomography [CT] or MRI) performed after symptom onset consistent with AD diagnosis
- •Ability to comply with testing and infusion regimen, including fluency in English or Spanish, adequate corrected visual acuity and hearing ability
- •On stable doses of regulatory authority approved AD medication(s) for at least 3 months prior to screening. These medications must be continued throughout this study.
- •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
排除标准
- •(Reasons why it might not be appropriate to participate):
- •Any other forms of dementia
- •Medical issues that might increase the risk of treatment with IGIV, 10%, such as:
- •Significant problems with blood pressure, heart disease, clotting disorders, strokes or recent heart attacks
- •Evidence of current bleeding in the brain by MRI
- •Serious problems with the liver or kidneys
- •Allergies to blood products
- •Medical issues that might interfere with the evaluation of the treatment of dementia or might make dementia worse, such as:
- •Recent treatment with chemotherapy or immune suppression
- •The recent use of other investigational drugs, especially antibody therapy for AD
- •Severe headaches or psychiatric problems
结局指标
主要结局
Change From Baseline at 18 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
时间窗: Baseline & 18 Months
The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner. Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration.
Change From Baseline at 18 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)
时间窗: Baseline & 18 months
The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer's Disease Cooperative Study (ADCS) at each site. Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration.
次要结局
- Change From Baseline at 9 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)(Baseline & 9 months)
- Change From Baseline at 9 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)(Baseline & 9 Months)
- Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Backward(Baseline & 18 months)
- Change From Baseline at 18 Months in the Modified Mini-Mental State Examination (3MS) Examination(Baseline & 18 months)
- Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment(Baseline & 18 Months)
- Change From Baseline at 18 Months in the Neuropsychiatric Inventory (NPI) Assessment(Baseline & 18 months)
- Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Caregiver Response(Baseline & 18 months)
- Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment(Baseline & 9 Months)
- Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Participant Response(Baseline & 18 months)
- Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Forward(Baseline & 18 months)
- Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: FAS Verbal Fluency(Baseline & 18 months)
- Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part B(Baseline & 18 months)
- Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Clock Drawing Test(Baseline & 18 months)
- Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class(Throughout the study period, approximately 4 years)
- Number of Infusions Discontinued, Slowed, or Interrupted Due to an Adverse Event (AE)(Throughout each infusion period)
- Number of Participants Experiencing a Clinically Significant Decrease in Hemoglobin (>1.5 g/dL) Between Consecutive Visits(Throughout the study period, approximately 4 years)
- Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Animals Category Fluency(Baseline & 18 months)
- Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class(Throughout the study period, approximately 4 years)
- Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class(Throughout the study period, approximately 4 years)
- Number of Infusions With Causally Associated Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs)(Throughout the study period, approximately 4 years)
- Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Symbol Substitution(Baseline & 18 months)
- Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part A(Baseline & 18 months)
- Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class(Throughout the study period, approximately 4 years)
- Number of Infusions Temporally Associated With Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs)(During or within 72 hours of completion of an infusion)
- Number of Participants Experiencing a Clinically Significant Rash(Throughout the study period, approximately 4 years)