2023-506918-45-00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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 798
- 试验地点
- 107
- 主要终点
- Change in the Clinical Dementia Rating – Sum of Boxes (CDR-SB) Score. From baseline (week 0) to week 104. Score on scale (0 to 18).
研究概览
简要总结
To confirm the superiority of oral semaglutide once daily versus placebo when added to standard of care with respect to the change in cognition and function as measured by the Clinical Dementia Rating – Sum of Boxes (CDR-SB) score from baseline to week 104 in patients with MCI or mild dementia, both of the Alzheimer’s type.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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 NIA-AA 2018 criteria
- •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
- •RBANS delayed memory index score of below or equal to 85
- •MMSE greater than or equal to 22
- •Amyloid positivity established with either amyloid PET or CSF A beta 1-42 or CSF A beta 1-42/A beta 1-40
- •If receiving an approved Alzheimer's disease treatment (such as acetylcholinesterase inhibitors, memantine or aducanumab) 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 MRI (or CT) scan suggestive of clinically significant structural CNS disease confirmed by central read (e.g. cerebral large-vessel disease [large vessel (cortical) infarcts more than 10 mm in diameter], prior macro-haemorrhage [more than 1 cm3], 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 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, 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 who´s depression is controlled with treatment can be included in the trial per investigator’s judgement
结局指标
主要结局
Change in the Clinical Dementia Rating – Sum of Boxes (CDR-SB) Score. From baseline (week 0) to week 104. Score on scale (0 to 18).
Change in the Clinical Dementia Rating – Sum of Boxes (CDR-SB) Score. From baseline (week 0) to week 104. Score on scale (0 to 18).
次要结局
- Change in the 24-item Alzheimer’s Disease Cooperative Study Activities of Daily Living Scale for MCI (ADCS-ADL-MCI) score. From baseline (week 0) to week 104. Score on scale (0 to 53).
- Time to progression to CDR global score ≥1.0 among patients with CDR global score = 0.5 at baseline. From baseline (week 0) up to week 156.
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (107)
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