NCT01343966已完成2 期
A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 448
- 试验地点
- 90
- 主要终点
- Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score
研究概览
简要总结
This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the safety and efficacy of MABT5102A in patients with mild to moderate Alzheimer's Disease.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorder Association (NINCDS-ADRDA) criteria
- •Mini-Mental State Examination (MMSE) score of 18-26 points at screening
- •Geriatric Depression Scale (GDS-15) score of < 6
- •Completion of 6 years of education (or good work history consistent with exclusion of mental retardation or other pervasive developmental disorders)
- •If receiving concurrent AD treatment, patient must be on the medication for at least 3 months at a stable dose for at least 2 months prior to randomization.
排除标准
- •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
- •History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system trauma
- •Hospitalization within 4 weeks prior to screening
- •Previous treatment with MABT5102A or any other therapeutic that targets Abeta
- •Treatment with any biologic therapy within 5 half-lives or 3 months prior to screening, whichever is longer, with the exception of routinely recommended vaccinations, which are allowed
研究组 & 干预措施
Part 1: Subcutaneous cohort exp
Experimental
干预措施: MABT5102A (Drug)
Part 2: Intravenous cohort exp
Experimental
干预措施: MABT5102A (Drug)
Part 1: Subcutaneous cohort
Placebo Comparator
Repeating subcutaneous injection
干预措施: placebo (Drug)
Part 2: Intravenous cohort
Placebo Comparator
Repeating intravenous infusion
干预措施: placebo (Drug)
结局指标
主要结局
Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score
时间窗: From baseline to Week 73
Change in Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score
时间窗: From baseline to Week 73
次要结局
- Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score(From baseline to Week 73)
研究者
研究点 (90)
Loading locations...
相似试验
已完成
2 期
A Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's DiseaseAlzheimer's DiseaseNCT01397578Genentech, Inc.91
Unknown
2 期
A Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Efficacy of UB-221 IV Infusion as an add-on Therapy in Patients With Chronic Spontaneous UrticariaChronic Spontaneous UrticariaNCT05298215United BioPharma25
已完成
2 期
Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)Depressive DisorderDepressive SymptomsDepressive Disorder, MajorDepressive EpisodeDepression SevereDepressionNCT05686408Tonix Pharmaceuticals, Inc.132
已完成
2 期
To Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic AlopeciaMale Pattern Hair LossAlopeciaNCT05218642Suzhou Kintor Pharmaceutical Inc,123
终止
2 期
A Study to Evaluate the Safety and Efficacy of Basmisanil in Adults With Severe Motor Impairment Following an Ischemic StrokeStrokeNCT02928393Hoffmann-La Roche5