NL-OMON51141招募中3 期
A randomised double-blind placebo-controlled clinical trial investigating the effect and safety of oral semaglutide in subjects with early Alzheimer*s disease (EVOKE plus) - EVOKE plus
ovo Nordisk0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Male or female, aged 55-85 years (both inclusive) at the time of signing
- •informed consent.
- •- MCI or mild dementia of the Alzheimer's type according to the National
- •Institute of Aging-Alzheimer's Association (NIA-AA) 2018 criteria
- •- Clinical Dementia Rating (CDR) global score of 0.5 and CDR of 0.5 or more in
- •at least one of the three instrumental activities of daily living categories
- •(personal care, home & hobbies, community affairs) Or CDR global score of 1.0
- •- Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
- •delayed memory index score of less than or equal to 85
- •- Mini-Mental State Examination (MMSE) greater than or equal to 22
- •- Amyloid positivity established with either amyloid positron emission
- •tomography (PET) or cerebrospinal fluid (CSF) Aβ1-42
- •- If receiving an approved Alzheimer's disease treatment (such as
- •acetylcholinesterase inhibitors or memantine) the dose must have been stable
- •for at least 3 months prior to screening and should not be changed during the
- •trial unless medically necessary
排除标准
- •-Brain magnetic resonance imaging (MRI) (or computerised tomography (CT)) scan
- •suggestive of clinically significant structural central nervous system (CNS)
- •disease confirmed by central read (e.g. cerebral large- vessel disease [large
- •vessel (cortical) infarcts greater than 10 mm in diameter], prior
- •macro-haemorrhage [ greater than 1 cm^3], cerebral vascular malformations,
- •cortical hemosiderosis, intracranial aneurism(s), intracranial tumours, changes
- •suggestive of normal pressure hydrocephalus)
- •-Brain MRI (or CT) scan suggestive of strategic infarcts defined as bilateral
- •thalamic lacunar infarcts and singular paramedian thalamic infarcts confirmed
- •by central read
- •-Evidence of a relevant neurological disorder other than mild cognitive
- •impairment (MCI) or mild dementia of the Alzheimer's type at screening,
- •including but not limited to Parkinson's disease, Lewy body disease,
- •frontotemporal dementia of any type, Huntington's disease, amyotrophic lateral
- •sclerosis, multiple sclerosis, systemic lupus erythematosus, progressive
- •supranuclear palsy, neurosyphilis, human immunodeficiency virus (HIV), learning
- •disability, intellectual disability, hypoxic cerebral damage, or significant
- •head trauma with loss of consciousness that led to persistent cognitive deficits
- •-Evidence of a clinically relevant or unstable psychiatric disorder, based on
- •Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria,
- •including schizophrenia or other psychotic disorder, or bipolar disorder. A
- •subject with a history of major depression who has not had an episode in the
- •last 24 months before the day of screening and is considered in remission or
- •whose depression is controlled with treatment can be included in the trial per
- •investigator's judgement
研究者
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