NCT02760602终止3 期
A 24-Month, Phase 3, Multicenter, Placebo-Controlled Study of Efficacy and Safety of Solanezumab Versus Placebo in Prodromal Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 103
- 主要终点
- Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score
研究概览
简要总结
The main purpose of this study is to investigate the safety and efficacy of the study drug solanezumab in participants with prodromal Alzheimer's disease (AD).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a diagnosis by the study investigator of a clinical syndrome of cognitive impairment consistent with prodromal AD per International Working Group (IWG) diagnostic criteria or mild cognitive impairment (MCI) due to AD per National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria.
- •Scores 17-28 on Montreal Cognitive Assessment (MoCA) at screening.
- •Scores <27 on free recall cutoff score from the Free and Cued Selective Reminding Test (FCSRT) (Picture version) at screening.
- •Scores ≤4 on Modified Hachinski Ischemia Scale (MHIS).
- •Scores >0 on the Functional Activities Questionnaire (FAQ).
- •Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF) result at screening consistent with the presence of amyloid pathology.
排除标准
- •Has had MRI or computerized tomography (CT) of brain within previous 2 years showing pathology that would be inconsistent with a diagnosis of AD.
- •Has known allergy to humanized monoclonal antibodies.
- •Has an ongoing clinically significant laboratory abnormality, as determined by the investigator.
- •Has screening MRI with results showing >4 amyloid related imaging abnormalities H (ARIA-H) micro-hemorrhages or presence of ARIA-E.
- •Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI.
- •Has received treatment with a stable dose of an acetylcholinesterase (AChEI) inhibitor or memantine for less than 2 months before randomization. (If a participant has recently stopped AChEIs and/or memantine, he or she must have discontinued treatment at least 2 months before randomization.)
研究组 & 干预措施
Solanezumab
Experimental
Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.
干预措施: Solanezumab (Drug)
Placebo
Experimental
Placebo given IV once every 4 weeks for up to 2 years.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score
时间窗: Baseline, 24 Months
ADAS-Cog14 is ADAS-Cog11 augmented with orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze-completion measures. The ADAS-Cog14 scale ranges from 0 to 90. Higher scores indicate greater disease severity.
次要结局
- Change From Baseline on the Mini Mental Status Examination (MMSE)(Baseline, 24 Months)
- Change From Baseline on the Neuropsychiatric Inventory (NPI)(Baseline, 24 Months)
- Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)(Baseline, 24 Months)
- Change From Baseline on the Free and Cued Selective Reminding Test (FCSRT)(Baseline, 24 Months)
- Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)(Baseline, 24 Months)
- Change From Baseline on the Montreal Cognitive Assessment (MoCA)(Baseline, 24 Months)
- Change From Baseline on the Functional Activities Questionnaire (FAQ)(Baseline, 24 Months)
- Change From Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(Baseline, 24 Months)
- Change From Baseline on the Resource Utilization in Dementia-Lite (RUD-Lite)(Baseline, 24 Months)
- Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)(Baseline, 24 Months)
- Change From Baseline on the EuroQol 5-Dimensional Health-Related Quality of Life Scale (EQ-5D)(Baseline, 24 Months)
- Change From Baseline in Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr)(Baseline, 24 Months)
- Change From Baseline on the Quality of Life in Alzheimer's Disease Scale (QoL-AD)(Baseline, 24 Months)
- Change From Baseline in Concentration of Plasma Amyloid-β Peptide (Aβ) and Plasma Solanezumab(Baseline, 24 Months)
- Change From Baseline in Neocortical Tau Deposits Using 18F-AV-1451 PET(Baseline, 24 Months)
- Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Aβ and CSF Tau Proteins(Baseline, 24 Months)
研究者
研究点 (103)
Loading locations...
相似试验
已完成
3 期
Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 StudyMigraineNCT02614196Eli Lilly and Company986
已完成
2 期
A Research Study of V3381 for the Treatment of Diabetic Peripheral Neuropathic PainPainDiabetic NeuropathiesNCT00375960Vernalis (R&D) Ltd50
已完成
3 期
A Study Of Galcanezumab In Participants With Episodic Cluster HeadacheEpisodic Cluster HeadacheNCT02397473Eli Lilly and Company109
招募中
3 期
A Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and/or Serious InfectionsNeutropeniaNCT06056297X4 Pharmaceuticals176
已完成
2 期
Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's DiseaseAlzheimer DiseaseNCT00277810Pfizer250