An Open Label Extension of XPro1595 in Patients With Alzheimer's Disease That Have Completed a Phase 1 or Phase 2 Study With XPro1595
NCT: NCT05522387 ·
Status: TERMINATED ·
Phase: Phase 2
· Sponsor: Inmune Bio, Inc.
· Started: 2023-02-21
· Est. Completion: 2024-07-05
Official Summary
The goal of this Phase 2 Open Label study is to evaluate long-term safety, tolerability, and efficacy of XPro1595 on measures of cognition, function and brain quality in individuals with Alzheimer's Disease.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 11 participants
Interventions
- DRUG: XPro1595 — Each enrolled patient will be treated with 1.0 mg/kg of XPro1595 as a subcutaneous injection once a week for 55, or 74 weeks, for a total exposure to XPro1595 of up to 78 weeks (18 months), depending on their previous study.
Primary Outcomes
- Number of participants who experience adverse events and serious adverse events (Weeks 55, or 74 in the OLE Study)
Secondary Outcomes
- To evaluate the change in cognitive performance following administration of open-label XPro1595 (Week 55 in the OLE Study)
- To evaluate the change in cognition and global function following administration of open-label XPro1595 (Week 55 in the OLE Study)
- To evaluate the change in non-cognitive behavioral symptoms following open-label administration of XPro1595 (Week 55 in the OLE Study)
- To evaluate the change Change from Baseline on the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS- MCI- ADL) (Week 55 in the OLE Study)
- To evaluate the change on blood inflammatory and neurodegeneration biomarkers following open-label administration of XPro1595 (on blood inflammatory and neurodegeneration biomarker amyloid) (Weeks 55, or 74 in the OLE Study)
Trial Locations
- KaRa MINDS, Macquarie Park, New South Wales, Australia
- Neuro Trials Victoria Pty Ltd T/A NeuroCentrix, Carlton, Victoria, Australia
- Austin Health, Ivanhoe, Victoria, Australia
- Australian Alzheimer's Research Foundation, Perth, Western Australia, Australia
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AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.