Study to Assess the Efficacy of XPro1595 in Patients With Mild Cognitive Impairment With Biomarkers of Inflammation
NCT05321498 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2023-09-28
Summary
The goal of this Phase 2 MCI study is to determine whether 1.0 mg/kg XPro1595 is superior to placebo at improving measures of cognition, functioning and brain quality in individuals with MCI and biomarkers associated with neuroinflammation (APOE4) and to evaluate safety, tolerability, and efficacy of XPro1595.
Conditions
- Mild Cognitive Impairment (MCI)
- Alzheimer Disease
- Dementia
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Tauopathies
- Neurodegenerative Diseases
- Mental Disorders
Interventions
- DRUG
-
XPro1595
XPro1595 will be delivered by subcutaneous injection once a week.
- DRUG
-
Placebo will be delivered by subcutaneous injection once a week
Sponsors & Collaborators
-
Inmune Bio, Inc.
lead INDUSTRY
Principal Investigators
-
Tara Lehner · INmune Bio
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 55 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-30
- Primary Completion
- 2023-10-26
- Completion
- 2023-10-26
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