A Randomized, Placebo-Controlled, Double-Blind Study of XPro1595 in Patients with Early Alzheimer’s Disease with Biomarkers of Inflammatio
- Conditions
- Early Alzheimer’s Disease with Biomarkers of InflammationMedDRA version: 20.0Level: PTClassification code: 10012293Term: Dementia of the Alzheimer's type uncomplicated Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2023-505396-71-00
- Lead Sponsor
- Inmune Bio Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 189
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of XPro1595 compared with placebo on cognitive performance in patients with early ADi;Secondary Objective: To assess the effect of XPro1595 compared with placebo on cognition and global function in patients with early ADi, To evaluate the effect of XPro1595 compared with placebo on E-Cog in patients with early ADi, To assess the effect of XPro1595 compared with placebo on noncognitive behavioral symptoms in patients with early ADi;Primary end point(s): 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
- Secondary Outcome Measures
Name Time Method Secondary end point(s):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)