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CompletedPhase 2

BCG and Plasma Amyloid in Non-Demented Adults

Lead sponsor

Mindful Diagnostics and Therapeutics, LLC

Asset

BCG vaccine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 50-80

Primary endpoint

•Plasma Amyloid

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDBCG-PANDA 01

NCT IDNCT04449926

Timeline

Milestones

Study first posted2020-06-29actual

Study start2020-11-09actual

Primary completion2021-12-04actual

Study completion2021-12-05actual

Last update posted2021-12-23actual

Assets

Drug assets

BCG vaccine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age80 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•BCG naive

•Ability to read, understand and sign consent form

Exclusion criteria

•Known allergy to (components of) the BCG vaccine or serious adverse events to prior vaccine administration

•Known active or latent Mycobacterium tuberculosis or with another mycobacterial species. A history of - or a suspicion of M. tuberculosis infection.

•Fever (>38 C) within the past 24 hours.

•Suspicion of active viral or bacterial infection.

•Vaccination in the past 4 weeks or expected vaccination during the study period, independent of the type of vaccination.

•Severely immunocompromised subjects. This exclusion category comprises:

a)subjects with known infection by the human immunodeficiency virus (HIV-1);

b)neutropenic subjects with less than 500 neutrophils/mm3;

c)subjects with solid organ transplantation;

d)subjects with bone marrow transplantation;

e)subjects under chemotherapy;

f)subjects with primary immunodeficiency;

g)severe lymphopenia with less than 400 lymphocytes/mm3;

h)treatment with any anti-cytokine therapies. i) treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months, or probable use of oral or intravenous steroids in the following four weeks.

•Active solid or non-solid malignancy or lymphoma within the prior two years.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Amyloid biomarkers

Other (unclassified)

Amyloid biomarkers

1 endpoint

Primary/protocol endpoint

Change in Plasma Amyloid

Time frame:9 months

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change in Immune Risk Profile

Time frame:nine months

change from baseline, improvement

Publications (7)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.