Early Alzheimer’s Disease with Biomarkers of Inflammation
Conditions
Brief summary
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
Detailed description
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)
Interventions
DRUGPlacebo to match XPro1595: The placebo contains the same ingredients as the active XPro1595 drug product except for the omission of the active ingredient.
DRUGXPro1595
Sponsors
Inmune Bio Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Czechia, France, Germany, Poland, Slovakia, Spain
Outcome results
None listed