NCT05183516

Tdap and Biomarkers of Alzheimer's Disease

Status unknown Phase 1, PHASE2 Last updated 25 August 2022

What this trial tests

Phase 1, PHASE2 trial testing tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine in Alzheimer Disease, Late Onset in 50 participants. Status unknown.

Timeline

1 May 2023

Primary endpoint
31 December 2023

31 March 2024

Quick facts

Lead sponsor	Mindful Diagnostics and Therapeutics, LLC
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 May 2023
Primary completion	31 December 2023
Estimated completion	31 March 2024
Sites	1 location across United States

Drugs / interventions tested

• tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine — 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

Recently, the Tdap (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis) vaccination was added to the list of immunizations associated with lower incidence of dementia. Plasma-based biomarkers for AD are a welcome alternative to expensive and invasive testing for Alzheimer's; these biomarkers include assessment of amyloid and tau and neurofilament light protein that assesses non-specific neurodegeneration. The investigators will test for these biomarkers, as well as some immune parameters, administer Tdap then repeat the blood tests in six months.

Publications & conference data

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

1. Alzheimer's disease drug development pipeline: 2022.
   Cummings J, Lee G, Nahed P, Kambar MEZN, et al · · 2022 · cited 369× · PMID 35516416 · DOI 10.1002/trc2.12295
2. Alzheimer's disease drug development pipeline: 2023.
   Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2023 · cited 326× · PMID 37251912 · DOI 10.1002/trc2.12385
3. Alzheimer's disease drug development pipeline: 2024.
   Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2024 · cited 209× · PMID 38659717 · DOI 10.1002/trc2.12465
4. Alzheimer's Disease: Novel Targets and Investigational Drugs for Disease Modification.
   Cummings JL, Osse AML, Kinney JW. · · 2023 · cited 75× · PMID 37728864 · DOI 10.1007/s40265-023-01938-w
5. Nasal delivery of neurotherapeutics <i>via</i> nanocarriers: Facets, aspects, and prospects.
   Rajput A, Pingale P, Dhapte-Pawar V. · · 2022 · cited 29× · PMID 36176429 · DOI 10.3389/fphar.2022.979682
6. Recent Advances in Therapeutics for the Treatment of Alzheimer's Disease.
   Thawabteh AM, Ghanem AW, AbuMadi S, Thaher D, et al · · 2024 · cited 26× · PMID 39519769 · DOI 10.3390/molecules29215131
7. The role for artificial intelligence in identifying combination therapies for Alzheimer's disease.
   Cheng F, Sha Z, Zhou Y, Hou Y, et al · · 2025 · cited 3× · PMID 41145341 · DOI 10.1016/j.tjpad.2025.100366