A Randomized, Placebo-Controlled, Double-Blind Study of XPro™ in Patients with Early Alzheimer’s Disease with Biomarkers of Inflammation - XPro1595-AD-02

Inmune Bio Inc.0 个研究点目标入组 189 人开始时间: 2023年7月24日最近更新: 2024年8月21日

适应症

试验速览

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•1.Adult patients 50 years to = 85 years of age at the time of consent 2.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); 3.CDR global rating at screening of 0.5 or 1 4.MMSE > 22; 5.ECog memory subscale items mean > 1.5 6.Presence of at least 1 inflammatory biomarker: •hsCRP > 1.5 mg/L •ESR > 10 mm/h •HbA1C > 6 DCCT % •At least 1 APOE4 allele

•1.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). 2.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. 3.Receives considerable help to carry out basic ADL living either in the home or as a resident in a nursing home or similar facility. 4.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. 5.History of substance abuse within 12 months; use of cannabis or cannabis products within 6months of consent. 6.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.

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