NL-OMON47731已完成不适用
European Prevention of Alzheimer's Dementia - Longitudinal Cohort Study (EPAD-LCS) - EPAD-LCS
niversity of Edinburgh0 个研究点目标入组 200 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age at least 50 years, checked and recorded at screening (Visit 1) only.
- •Fulfils the criteria set by the Balancing Committee [BC]
- •Able to read and write and with minimum 5 years of formal education, checked
- •and recorded at screening (Visit 1) only.
- •Willing in principle to participate in the EPAD PoC trial subject to further
- •informed consent
- •Have a study partner or can identify someone willing in principle to be a
- •study partner
排除标准
- •Research participants who fulfil diagnostic criteria for any type of dementia
- •(e.g. National Institute of Neurological and Communicative Disorders and Stroke
- •and Alzheimer's Disease and Related Disorders Association [NINCDS-ADRDA] for
- •AD; Lund Criteria for fronto-temporal dementia [FTD], McKeith Criteria for
- •dementia with Lewy bodies [DLB], National Institute of Neurological Disorders
- •and Stroke and Association Internationale pour la Recherché et l'Enseignement
- •en Neurosciences [NINCDS-AIREN] Criteria for Vascular Dementia)
- •CDR >=>=1 at screening (Visit 1)
- •Known carriers of a Presenilin (PSEN) PSEN1, PSEN2 or APP mutation associated
- •with Autosomal Dominant AD or any other neurodegenerative disease
- •Presence of any neurological, psychiatric or medical conditions associated
- •with a long-term risk of significant cognitive impairment or dementia including
- •but not limited to pre-manifest Huntington*s disease, multiple sclerosis,
- •Parkinson*s disease, Down syndrome, active alcohol/drug abuse or major
- •psychiatric disorders including current major depressive disorder,
- •schizophrenia, schizoaffective or bipolar disorder.
- •Any cancer or history of cancer in the preceding 5 years (excluding cutaneous
- •basal or squamous cell cancer resolved by excision and localised prostate
- •cancer in male subjects)
- •Any current medical conditions that are clinically significant and might make
- •the subject*s participation in an investigational trial unsafe, e.g.,
- •uncontrolled or unstable disease of any major organ system; history within the
- •last 6 months of any acute illness of a major organ system requiring emergency
- •care or hospitalization, including re-vascularisation procedures; severe renal
- •or hepatic failure; unstable or poorly controlled diabetesdiabetes mellitus,
- •hypertension, or heart failure; malignant neoplasms within the last 5 years
- •(except for basal or squamous cell carcinoma in situ of the skin, or localized
- •prostate cancer in male subjects); any clinically relevant abnormalities in
- •blood parameters included in local Trial Delivery CentreCentre routine
- •assessments; severe loss of vision, hearing or communicative ability; or any
- •conditions preventing co-operation or completion of the required assessments in
- •the trial, as judged by the investigator
- •Any contraindications for MRI/positron emission tomography (PET) scan
- •Any contraindications for Lumbar Puncture at visit 1.
- •Any evidence of intracranial pathology which, in the opinion of the
- •Investigator, may affect cognition, including but not limited to brain tumours
- •(benign or malignant), aneurysm or arteriovenous malformations, territorial
- •stroke (excluding smaller watershed strokes), recent haemorrhage (parenchymal
- •or subdural), or obstructive hydrocephalus. Participants with a MRI scan
- •demonstrating markers of small vessel disease (e.g. white matter changes or
- •lacunar infarcts) judged to be clinically insignificant, or microbleeds are
- •Participation in a clinical trial of an investigational product (CTIMP) in
- •the last 30 days . Participation in a non-CTIMP or an observational arm of a
- •CTIMP is not considered an exclusion criterion. Co-enrolment in the Amyloid
- •Imaging to Prevent Alzheimer*s Disease (AMYPAD) Prognostic and Natural History
- •Study (PNHS) is not considered to fall under this exclusion crite
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