2023-505396-71-00招募中2 期
A Randomized, Placebo-Controlled, Double-Blind Study of XPro™ in Patients with Early Alzheimer’s Disease with Biomarkers of Inflammation
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 127
- 试验地点
- 47
- 主要终点
- Change in the Early and Mild Alzheimer’s Cognitive Composite (EMACC) from Baseline to Week 24 in the following assessments: International Shopping List Test-Immediate Recall Digit Span Forward and Backward Category Fluency Test (DKEFS) Letter Fluency Test (DKEFS) Trail Making Test Parts A and B Digit Symbol Coding Test
研究概览
简要总结
To assess the efficacy of XPro1595 compared with placebo on cognitive performance in patients with early ADi
研究设计
- 分配方式
- Randomized
- 主要目的
- Double-Blind Treatment
- 盲法
- Double (Carer, Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Adult patients 50 years to ≤ 85 years of age at the time of consent
- •Diagnosed with MCI of probable Alzheimer’s disease (Jack et al. 2018; NIA-AA) or mild dementia as clinically described in McKhann, (2011) and corresponding to stages 3 or 4 of the revised AD staging system (Jack, 2018). (NIA - AA);
- •CDR global rating at screening of 0.5 or 1
- •ECog memory subscale items mean > 1.5
- •Presence of at least 1 inflammatory biomarker: • hsCRP > 1.5 mg/L • ESR > 10 mm/h • HbA1C > 6 DCCT % • At least 1 APOE4 allele
排除标准
- •Have any contraindications to MRI scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (e.g., in-skull and cardiac devices other than those approved as safe for use in MRI scanners).
- •Have any evidence of other clinically significant lesion(s) that could confound or indicate a dementia diagnosis other than AD on brain CT and/or MRI at Screening.
- •Receives considerable help to carry out basic ADL living either in the home or as a resident in a nursing home or similar facility.
- •Lifetime history of a major psychiatric disorder including schizophrenia and bipolar disorder. Major depressive disorder that has resulted in 2 or more hospitalizations in a lifetime. Major depressive episode during the past 5 years that is judged by the clinical team unlikely to have been part of Alzheimer’s prodrome. History of suicidal behavior, or answer of ‘yes” to C-SSRS suicidal ideation items 4 or 5 within 12 months of screening.
- •History of substance abuse within 12 months; use of cannabis or cannabis products within 6months of consent.
- •Have taken within the last 90 days from Day 1: corticosteroids or other immunosuppressive drugs, thalidomide or other TNF active drugs, minocycline, first- or second-generation antipsychotics (e.g., aripripozole) or aducanumab.
结局指标
主要结局
Change in the Early and Mild Alzheimer’s Cognitive Composite (EMACC) from Baseline to Week 24 in the following assessments: International Shopping List Test-Immediate Recall Digit Span Forward and Backward Category Fluency Test (DKEFS) Letter Fluency Test (DKEFS) Trail Making Test Parts A and B Digit Symbol Coding Test
Change in the Early and Mild Alzheimer’s Cognitive Composite (EMACC) from Baseline to Week 24 in the following assessments: International Shopping List Test-Immediate Recall Digit Span Forward and Backward Category Fluency Test (DKEFS) Letter Fluency Test (DKEFS) Trail Making Test Parts A and B Digit Symbol Coding Test
次要结局
- Change from Baseline to Week 24 in Clinical Dementia Rating Scale (CDR) Change from Baseline to Week 24 in Everyday Cognition (E-Cog) Change from Baseline to Week 24 in (Neuropsychiatric Inventory [NPI-12] caregiver items)
研究者
Head of Neuroscience
Scientific
Inmune Bio Inc.
研究点 (47)
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