NCT05004688

A Trial to Evaluate the Effects of BCG in Adults With MCI and Mild-to-Moderate AD

An Open-label Trial to Evaluate the Effects of BCG Immunization on Biomarkers of Inflammation/Immune Response and Alzheimer's Disease in Adults With Mild Cognitive Impairment and Mild-to-Moderate Dementia Due to Alzheimer's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Steven E Arnold, MD · Academic / Other
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A study of the effects of Bacillus Calmette-Guérin (BCG) immunization on cerebrospinal fluid and blood-based biomarkers in older with mild cognitive impairment and mild-to-moderate to Alzheimer's disease.

Detailed description

This single-site, open-label trial will investigate the effects of BCG vaccination on IIR and AD biofluid biomarkers, magnetic resonance imaging (MRI) biomarkers, and neurocognitive/behavioral functioning over a one year period in older adults with mild cognitive impairment (MCI) to mild-to-moderate dementia due to AD. This study will also gather data on tolerability and safety.

Conditions

• Mild Cognitive Impairment
• Mild Dementia
• Moderate Dementia
• Alzheimer Disease

Interventions

Type	Name	Description
BIOLOGICAL	Biological/Vaccine: Bacillus Calmette-Guerin (BCG)	Two Bacillus Calmette-Guérin (Japan BCG) vaccine injections spaced four week apart. Each injection will have 0.36-3.9 x 10\^6 colony forming units (CFU) reconstituted in 0.1 mL saline.

Timeline

• Start date: 2022-03-25
• Primary completion: 2024-01-15
• Completion: 2024-01-15
• First posted: 2021-08-13
• Last updated: 2025-04-13
• Results posted: 2025-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study