Amyloid pathology in cognitively normal elderly subjects (PreclinAD)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- 1.To identify clinical markers and biomarkers for amyloid pathology in cognitively normal subjects; 2.To identify risk factors for (change in) amyloid pathology in cognitively normal subjects, 3.To identify prognostic markers for cognitive decline in cognitively normal subjects with amyloid pathology
研究概览
简要总结
To validate known and to discover novel diagnostic markers and risk factors for amyloid pathology in cognitively normal subjects and to validate known and to discover novel predictors for cognitive decline in cognitively normal subjects with amyloid pathology.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 是
入选标准
- •In order to be eligible to participate in this study, a participant must meet all of the following criteria: Age 60-100 years Telephone Interview for Cognitive Status modified (TICS-m) >22 (de Jager, Budge et al. 2003) Geriatric Depression Scale (GDS) (15 item) <11(Yesavage, Brink et al. 1982) Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) 10 word list immediate and delayed recall (> -1.5 SD of age adjusted normative data) (Morris, Heyman et al. 1989) Clinical Dementia Rating (CDR) scale of 0 with a score on the memory sub domain of 0 (Morris 1993)
排除标准
- •A potential participant who meets any of the following criteria will be excluded from participation in this study: Clinical diagnosis of mild cognitive impairment or probable AD Severe head trauma, with loss of consciousness Brain tumour (past, present) Schizophrenia, bipolar disorders, or recurrent psychotic disorders Stroke resulting in physical impairment Neurodegenerative disorders (e.g. Huntington disease, cortical basal degeneration, multiple system atrophy, Creutzfeldt-Jacob disease, primary progressive aphasia, Parkinson’s disease) Epilepsy, currently using antiepileptic drugs (AEDs) Brain infection (e.g. herpes simplex encephalitis) Cancer with terminal life expectancy Known B12 vitamin deficiency without treatment Uncontrolled diabetes mellitus Known thyroid disease without treatment History of recreational drug use Alcohol consumption: >35 units per week Physical morbidity or illness which will not permit attendance at visit sessions Contraindication for MRI (e.g. metal implants, pacemaker etc.) Medications that may impair cognition, at the discretion of the investigator, e.g.: o High dose benzodiazepine o Lithium carbonate o Antipsychotics including atypical agents o High dose antidepressants o Parkinson’s disease medicines
结局指标
主要结局
1.To identify clinical markers and biomarkers for amyloid pathology in cognitively normal subjects; 2.To identify risk factors for (change in) amyloid pathology in cognitively normal subjects, 3.To identify prognostic markers for cognitive decline in cognitively normal subjects with amyloid pathology
1.To identify clinical markers and biomarkers for amyloid pathology in cognitively normal subjects; 2.To identify risk factors for (change in) amyloid pathology in cognitively normal subjects, 3.To identify prognostic markers for cognitive decline in cognitively normal subjects with amyloid pathology
次要结局
未报告次要终点
研究者
Anouk den Braber
Scientific
Amsterdam UMC Stichting