EUCTR2020-003966-38-IS进行中（未招募）1 期
EXploratory PLatform trial on Anti-INflammatory agents in Alzheimer’s Disease (EXPLAIN-AD): A randomized, placebo controlled, multicenter platform study to evaluate the efficacy, safety, tolerability and pharmacokinetics of various anti-inflammatory agents in patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease - EXploratory PLatform trial on Anti-INflammatory agents in Alzheimer’s Disease (EXPLAIN-AD)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 900
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
- 性别
- All
入选标准
- •1. Male or female, age = 45 years and = 90 years at the time of signing the informed consent;
- •2. Participant has a reliable study partner or caregiver can accompany the participant to all visits;
- •3. A diagnosis of probable MCI due to AD or mild AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria;
- •4. Confirmed amyloid and tau positivity via CSF sampling performed at screening;
- •5. Mini-Mental State Examination (MMSE) total score of 20 to 30 (inclusive) and DSST score at least one standard deviation (SD) below normative data at point of screening.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 720
排除标准
- •1. Use of other investigational agents prior to screening until:a) Small molecules: after five half-lives, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; OR b) Biologicals: blood concentration has returned to baseline (or below serological responder threshold) for antibodies induced by active immunotherapy; or five half-lives for monoclonal antibodies or other biologicals;
- •2. Current medical or neurological condition that might impact cognition or performance on cognitive assessments, e.g., MCI not due to AD, non-Alzheimer dementia, Huntington’s disease, Parkinson’s disease, stroke, schizophrenia, bipolar disorder, active major depression, multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), active seizure disorder, or history of traumatic brain injury associated with loss of consciousness and ongoing residual transient or permanent neurological signs/symptoms including cognitive deficits, and/or associated with skull fracture;
- •3. If a historical MRI or CT scan has been performed, signs of major cerebrovascular disease shown on such scans (i.e., presence of infarction in greater than 25% of white matter; more than one lacune within basal ganglia or more than 2 lacunes in white matter);
- •4. Diagnosis of vascular dementia prior to screening (e.g.., modified Hachinski Ischaemic Scale score > 6 or those who meet the NINDS AIREN criteria for vascular dementia);
- •5. Previous exposure to amyloid vaccines or intravenous immunoglobulins meant to treat Alzheimer's disease.
研究者
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Study of the efficacy and safety of various anti-inflammatory agents in participants with mild cognitive impairment or mild Alzheimer's DiseaseMild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s diseaseMedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852EUCTR2020-003966-38-FIovartis Pharma AG900
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