NCT05809908尚未招募3 期
A Phase 3, 26-Week, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Daily Administration of Tricaprilin as AC-OLE-01-VA in Participants With Mild to Moderate Alzheimer's Disease Dementia
Cerecin0 个研究点目标入组 535 人开始时间: 2026年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 535
- 主要终点
- Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) total score
研究概览
简要总结
The purpose of this study is to evaluate the effects of tricaprilin (20 g twice a day) on cognition, global function, activities of daily living, resource utilisation, safety, and tolerability, in participants with mild to moderate AD dementia.
This is a randomised, double-blind, placebo-controlled, parallel-group, multi-centre design in up to 535 participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mini Mental State Exam (MMSE) score between 14 to 24
- •Meets diagnostic clinical criteria of probable Alzheimer's disease dementia according to the NIA-AA criteria
- •Magnetic resonance imaging (MRI) scan less than 12 months before Baseline compatible with a diagnosis of probable AD
- •Plasma biomarker result supporting a diagnosis of AD before Baseline (Aβ42/40 and/or pTau217)
- •Confirmed APOE4 genotype result prior to Baseline
- •Participants taking the following cholinesterase inhibitors: donepezil, galantamine, or rivastigmine; and/or sodium oligomannate (GV-971), and/or memantine, and/or GLP-1 antagonist and/or other agents which may impact cognition are eligible for enrolment: a) If the participant has been taking such medication(s)/products for 3 months or more at Screening Visit 1; b) If the current dosage regimen is within the approved dose range; c) The daily dose has remained unchanged for at least 6 weeks prior to screening; d) If the dose is not expected to change during study participation
排除标准
- •Has any medical/neurological/psychiatric condition, other than AD, that could explain the participant's dementia or cognitive impairment, such as but not limited to e.g., structural abnormality, traumatic brain injury, stroke, epilepsy, Parkinson's disease, alcohol-related dementia, current major depressive episode
- •The following GI conditions are exclusionary: a) Inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease), GI bleed (upper or lower), or peptic ulcer disease; any of these conditions are exclusionary, if active in the past 5 years. Participants with remote quiescent disease, at the Investigators discretion , are not excluded; b) Participants with current or a history of (within the last 5 years) any of the following conditions are excluded: clinically significant reflux disease (e.g., Barrett's oesophagus, stricture, ulcer, haemorrhage), or severe gastroesophageal reflux disease that, in the opinion of the Investigator, is not well-controlled by medication; c) Irritable bowel syndrome, diverticular disease (e.g., diverticulosis, or diverticulitis), or chronic gastritis; any of these conditions are exclusionary if there has been an acute event within 1 year prior to Screening; d) History of gastric food intolerance, whether it be allergy or chronic oversensitivity, or a history of stomach upset reaction to a variety of foods
- •Current or previous treatment with any anti-amyloid or anti-Tau antibodies such as lecanemab and donanemab within 6 months prior to the day of screening
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo formulation, twice daily for 26 weeks, liquid for oral administration
干预措施: Placebo (Drug)
Tricaprilin
Active Comparator
Tricaprilin formulation twice daily for 26 weeks, liquid for oral administration
干预措施: Tricaprilin (Drug)
结局指标
主要结局
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) total score
时间窗: 26 weeks
The ADAS-Cog is a cognitive scale that assesses memory, language, orientation, and praxis with a total score range of 0 (no impairment) to 70 (severe impairment).
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)
时间窗: 26 weeks
The ADCS-CGIC is a clinician-rated scale of cognition, function, and behavior. Scores range from 1 (marked improvement) to 7 (marked worsening).
次要结局
- Change From Baseline in a composite score of Category Fluency Test (CFT), Controlled Oral Word Association Test (COWAT), and ADAS-Cog subtests Word Recall, Word Recognition and Orientation(26 weeks)
- Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score(26 weeks)
- Change From Baseline in a composite score of Category Fluency Test (CFT), Controlled Oral Word Association Test (COWAT), and ADAS-Cog subtests Word Recall, Word Recognition and Orientation(26 weeks)
- Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score(26 weeks)
研究者
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