NCT02388152终止1 期
Interventional, Open-label, Multiple-immunization Extension Study on the Safety, Tolerability and Immunogenicity of Lu AF20513/Adjuvant in Patients With Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Safety and tolerability assessed by composite outcome measure consisting of absolute values and changes from baseline in: adverse events, clinical safety laboratory tests, vital signs
研究概览
简要总结
The purpose of this study is to determine if multiple immunizations with Lu AF20513 is tolerable and safe in patients with mild Alzheimer's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has a diagnosis of probable Alzheimer's Disease (AD) consistent with the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
- •The patient has a pattern of antibodies in cerebrospinal fluid (CSF) consistent with an amyloid plaque load
- •The patient is a man or a woman, and between ≥60 and ≤85 years of age
- •The patient has an MRI (performed within 3 months before screening) with results consistent with the diagnosis of probable AD
- •The patient has a mild severity of dementia
- •The patient has a knowledgeable and reliable caregiver who will be available and able to: accompany the patient to all clinical visits, monitor IRE after each immunization, and participate with the patient at all phone visits during the study AD
- •Patients must have completed Part A before being eligible for continued immunisations in Part B
排除标准
- •The patient has evidence of mixed etiology of dementia (i.e. absence of other neurodegenerative, neuroinflammatory or cerebrovascular disease, or another neurological, mental or systemic disease or condition likely contributing to cognitive decline)
- •The patient has clinical and radiological findings that fulfil the standards of the National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherché et l'Enseignement en Neurosciences (NINDS-AIREN) criteria for vascular dementia
- •The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-5-TR) Axis I disorder other than AD; including amnestic disorders, delirium, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, post-traumatic stress disorder and/or cognitive disorder not otherwise specified, (note: patients may be included if treated with a stable dose of antidepressants for at least 2 months and not fulfilling DSM-5-TR criteria for depression at Screening)
- •The patient's eligibility MRI scan (1.5T) shows findings that correspond to more than 4 brain micro haemorrhages
- •The patient has extensive white matter lesions as shown on the screening MRI scan (1.5T)
- •Other protocol-defined inclusion and exclusion criteria do apply
研究组 & 干预措施
Lu AF20513, low dose (Cohort 1)
Experimental
10 Patients with mild Alzheimer's.
干预措施: Lu AF20513, low dose (Drug)
Lu AF20513, medium dose (Cohort 2)
Experimental
10 Patients with mild Alzheimer's.
干预措施: Lu AF20513, medium dose (Drug)
Lu AF20513, high dose (Cohort 3)
Experimental
15 Patients with mild Alzheimer's.
干预措施: Lu AF20513, high dose (Drug)
Lu AF20513, double high dose (Cohort 4)
Experimental
15 Patients with mild Alzheimer's.
干预措施: Lu AF20513, double high dose (Drug)
结局指标
主要结局
Safety and tolerability assessed by composite outcome measure consisting of absolute values and changes from baseline in: adverse events, clinical safety laboratory tests, vital signs
时间窗: Baseline to week 96
ECGs, physical and neurological examination, suicidality assessment, Immunisation-Related Events (IRE) (selected from Brighton Collaboration guidelines) and magnetic resonance imaging (MRI) safety scans
Antibody titre
时间窗: Baseline to week 96
次要结局
未报告次要终点
研究者
研究点 (5)
Loading locations...
相似试验
终止
1 期
Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to ADAlzheimer DiseaseNCT03819699H. Lundbeck A/S3
终止
1 期
A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD)Alzheimer's DiseaseNCT03668405H. Lundbeck A/S18
已完成
1 期
Open Label Extension Study Evaluating Safety and Tolerability of AAB-003 (PF-05236812) in Subject With Mild to Moderate Alzheimer's DiseaseAlzheimer's DiseaseNCT01369225Pfizer52
已完成
4 期
The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza VaccineSeasonal InfluenzaHand, Foot and Mouth DiseaseNCT04133584Zhejiang Provincial Center for Disease Control and Prevention1,134
终止
1 期
Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Colorectal CancerRectal CancerColorectal CancerColon CancerNCT00677612Tokyo University14