NCT04055532撤回不适用
Biomarkers in Neurodegenerative Diseases
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Performance on Batteries of Cognitive Tests
研究概览
简要总结
The general purpose of this observational study is to examine biomarkers associated with the pathology of neurodegenerative diseases to potentially develop novel therapeutic approaches.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MCI, AD, DLB, FTLD, PDD, TEA, TLE, SCA, HAND, ALS, PLS, or normal control.
- •Age 18 or older
- •Reliable informant with frequent contact with participant
- •Mini Mental State Exam (MMSE) ≥15 AND/OR Clinical Dementia Rating (CDR) less than 2
- •Able to undergo extensive psychometric testing
排除标准
- •Any conditions that could account for cognitive deficits in addition to a neurodegenerative disease, including but not limited to:
- •Past or present diagnosis of Korsakoff's syndrome
- •Alcohol or substance abuse preceding dementia & still present within 5 years of onset
- •Present untreated vitamin B12 or folate deficiency
- •Present untreated hypothyroidism
- •Past or present head trauma with persistent deficits
- •Present untreated syphilis
- •Past or present multiple sclerosis or another neuro-inflammatory disorder
- •Past or present vascular or multi-infarct dementia
- •Past or present diagnosis of huntington's disease
- •Past or present normal pressure hydrocephalus
- •Past or present central nervous system (CNS) lesions deemed to be clinically significant
- •Unresolved or present subdural hematoma
- •Past or present Ischemic Vascular Dementia
- •Past or present intracerebral hemorrhage
- •Present systematic liver disease
- •Present renal insufficiency requiring dialysis
- •Present encephalitis or meningitis
- •Present anxiety disorder (not due to dementia and requiring medication more than 3x per week)
- •Present severe periventricular white matter disease or greater than grade 4 white matter lesions
- •Present lacunar infarcts deemed to clinically significant
- •Present cortical stroke
- •Present respiratory condition requiring oxygen
- •Present significant systemic medical illness, such as cancer requiring chemotherapy or end stage cardiac insufficiency
- •Present inability to safely scan in an MRI
- •Present pregnancy or lactation - Female participants will be asked to confirm that they are not pregnant and do not plan to become pregnant.
- •Present current medication likely to affect CNS functions:
- •Benzodiazepines (no triazolam, but other short-acting benzodiazepines are OK)
- •Antidepressant therapy with amitriptyline or doxepin or tx not stable during past year
- •Neuroleptics in the phenothiazine and haloperidol families (atypicals OK)
- •Narcotics (codeine is OK, but hold 24 hours before neuropsychological testing)
- •Anti-seizure medication outside of therapeutic ranges
- •Antihistamines (> 3x per week; hold 24 hours before neuropsychological testing)
结局指标
主要结局
Performance on Batteries of Cognitive Tests
时间窗: 2-5 Years
Performance on batteries of cognitive tests as measured by the Modified Autobiographical Memory Interview (MAMI), Stroop Test, CDR-SOB, Spontaneous Speech Test, and the Neuropsychological Battery from the Uniform Data Set.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Biological and Cognitive Marker of Neurodegeneration in Obstructive Sleep Apnea PatientsSleep Apnea, ObstructiveNCT06167369Technische Universität Dresden136
已完成
不适用
Development of biomarker in neurodegenerative disease and psychiatric disorderseurodegenerative disease Psychiatric disorderJPRN-UMIN000010883Yokohama City University Graduate School of Medicine58
招募中
不适用
Application of Biomarkers in Neurological DiseasesBiomarkersNCT05881226Yi Yang3,000
已完成
不适用
Research of Biomarkers in Duchenne Muscular Dystrophy PatientsDuchenne Muscular Dystrophy (DMD)NCT01380964Genethon220
招募中
不适用
Development of novel biomarkers of neurodegenerative diseases-comprehensive analysis of the proteins and the RNAs in exosomes extracted from cerebrospinal fluid and urineJPRN-UMIN000015133Department of Neurology and Stroke Medicine, Yokohama City University130