Who is sponsoring NCT04449926?

NCT04449926 is sponsored by Mindful Diagnostics and Therapeutics, LLC.

What drugs are being tested in NCT04449926?

Interventions in NCT04449926: Bacillus of Calmette and Guerin (BCG).

What condition does NCT04449926 study?

NCT04449926 studies Alzheimer Disease, Late Onset.

Is NCT04449926 still recruiting?

NCT04449926 is currently completed. Last updated 23 December 2021.

Last reviewed 2021-12-23 · How we verify

NCT04449926

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

BCG and Plasma Amyloid in Non-Demented Adults

Completed Phase 2 Last updated 23 December 2021

What this trial tests

Phase 2 trial testing Bacillus of Calmette and Guerin (BCG) in Alzheimer Disease, Late Onset in 49 participants. Completed in 5 December 2021.

Timeline

9 November 2020

Primary endpoint
4 December 2021

5 December 2021

Quick facts

Lead sponsor	Mindful Diagnostics and Therapeutics, LLC
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	49
Start date	9 November 2020
Primary completion	4 December 2021
Estimated completion	5 December 2021
Sites	1 location across United States

Drugs / interventions tested

Bacillus of Calmette and Guerin (BCG) — full drug profile →

Conditions studied

Alzheimer Disease, Late Onset — all drugs for Alzheimer Disease, Late Onset →

Sponsor

Mindful Diagnostics and Therapeutics, LLC — full company profile →

Who can join

Adults 50 to 80, any sex, with Alzheimer Disease, Late Onset. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

BCG vaccination, the most widely used vaccination in the world, is used to reduce risk of tuberculosis infection; it is used for other mycobacterial infections as well, benefiting leprosy and Buruli ulcer. BCG has "heterologous" effects that aids in an array of non-mycobacterial and viral infections as well as bladder cancer. It is the heterologous effect, sometimes called the "off-target" effect that may offer benefit in Alzheimer's disease. Population studies and studies of adults receiving BCG show a lessened risk of Alzheimer's disease. The study will see if BCG vaccination will alter a plasma test for amyloid, a biomarker for cerebral amyloid.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Alzheimer's disease drug development pipeline: 2021.
Cummings J, Lee G, Zhong K, Fonseca J, et al · · 2021 · cited 312× · PMID 34095440 · DOI 10.1002/trc2.12179
Immune Memory in Aging: a Wide Perspective Covering Microbiota, Brain, Metabolism, and Epigenetics.
Bulut O, Kilic G, Domínguez-Andrés J. · · 2022 · cited 24× · PMID 34910283 · DOI 10.1007/s12016-021-08905-x
Evaluation of BCG Vaccination and Plasma Amyloid: A Prospective, Pilot Study with Implications for Alzheimer's Disease.
Dow CT, Greenblatt CL, Chan ED, Dow JF. · · 2022 · cited 12× · PMID 35208878 · DOI 10.3390/microorganisms10020424
Vaccines and Dementia: Part II. Efficacy of BCG and Other Vaccines Against Dementia.
Greenblatt CL, Lathe R. · · 2024 · cited 8× · PMID 38393913 · DOI 10.3233/jad-231323

Verify or expand the search:

Other recruiting trials for Alzheimer Disease, Late Onset

Currently open trials in the same condition.

NCT06448403 — Multimodal Assesment of Alzheimer Patients · recruiting
NCT05655195 — Chronic Treatment of Alzheimer's Disease by Gamma Light and Sound Therapy · NA · recruiting
NCT06203106 — NYSCF Scientific Discovery Biobank · recruiting
NCT05138848 — Time-in-bed Restriction in Older Adults With Sleep Difficulties With and Without Risk for Alzheimer's Disease · EARLY_PHASE1 · recruiting
NCT04270474 — Reducing Risk of Dementia Through Deprescribing · NA · active not recruiting

Other Mindful Diagnostics and Therapeutics, LLC trials

Trials by the same sponsor.

NCT05183516 — Tdap and Biomarkers of Alzheimer's Disease · Phase 1, PHASE2 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04449926 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mindful Diagnostics and Therapeutics, LLC
Last refreshed: 23 December 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04449926.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing