CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Biological/Vaccine: Bacillus Calmette-Guerin (BCG)biological
Likely dose
0.36–3.9×10^6 CFU per injection (two injections 4 weeks apart)AI-extracted
Key inclusion· 9
  • ✓Age 55–85 years
  • ✓Mild cognitive impairment or mild-to-moderate dementia due to Alzheimer's disease per 2011 NIA-AA criteria
  • ✓MoCA score ≥8 at screening
  • ✓Global CDR 0.5–2 (inclusive) at screening
Key exclusion· 16
  • ✕History of chronic infectious disease (e.g. HIV, untreated/active hepatitis)
  • ✕History of tuberculosis or positive IGRA/QuantiFERON test
  • ✕Prior BCG vaccination or positive T-spot tuberculosis test
  • ✕Positive SARS-CoV-2 PCR within 3 months of screening or known COVID-19 exposure/symptoms within 1 month

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05004688
NCT05004688Phase 2Completed
CompareCT.gov

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

Steven E Arnold, MD·interventional·Posted Aug 13, 2021·Updated Apr 13, 2025

In Brief

A Phase 2 clinical trial evaluating Biological/Vaccine: Bacillus Calmette-Guerin (BCG) for Mild Cognitive Impairment and 3 related conditions. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMild Cognitive Impairment, Mild Dementia, Moderate Dementia, Alzheimer Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedAug 13, 2021
Enrollment StartMar 25, 2022
Primary CompletionJan 15, 2024
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 4.9 years ago

Interventions

Biological/Vaccine: Bacillus Calmette-Guerin (BCG)biological

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.