A Pilot Study of the Effects of Bacillus Calmette-Guérin (BCG) Immunization on Cerebrospinal Fluid and Blood-based Biomarkers in Older Adults.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy
- Mild Cognitive Impairment
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 55 years and 80 years
- Gender
- Both males and females
Description
This single-site, open-label clinical trial will investigate the immune and neurobiological effects of BCG vaccination in cognitively unimpaired older adults and older adults with memory and thinking problems by measuring target engagement, pharmacodynamic response, and effect on Alzheimer's disease...
This single-site, open-label clinical trial will investigate the immune and neurobiological effects of BCG vaccination in cognitively unimpaired older adults and older adults with memory and thinking problems by measuring target engagement, pharmacodynamic response, and effect on Alzheimer's disease (AD) pathology and immune response markers. This study will also gather data on study feasibility, tolerability, and safety.
Tracking Information
- NCT #
- NCT04507126
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Steven E Arnold, MD Massachusetts General Hospital Principal Investigator: Denise Faustman, MD, PhD Massachusetts General Hospital
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