NCT06169826 is a Phase 4 clinical trial of l-Histidine in Alzheimer Disease, sponsored by Wake Forest University Health Sciences.

Who is sponsoring NCT06169826?

NCT06169826 is sponsored by Wake Forest University Health Sciences.

What drugs are being tested in NCT06169826?

Interventions in NCT06169826: l-Histidine, Control.

What condition does NCT06169826 study?

NCT06169826 studies Alzheimer Disease.

Is NCT06169826 still recruiting?

NCT06169826 is currently withdrawn. Last updated 23 April 2025.

Last reviewed 2025-04-23 · How we verify

NCT06169826

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

Histidine Oral Supplementation as a Therapeutic Modality for Alzheimer's Disease

Withdrawn Phase 4 Last updated 23 April 2025

What this trial tests

Phase 4 trial testing l-Histidine in Alzheimer Disease. Withdrawn.

Timeline

1 April 2025

Primary endpoint
1 April 2026

1 April 2026

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 4
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Start date	1 April 2025
Primary completion	1 April 2026
Estimated completion	1 April 2026
Sites	1 location across United States

Drugs / interventions tested

l-Histidine — full drug profile →
Control

Conditions studied

Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

Wake Forest University Health Sciences

Who can join

50 and older, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Clinical Dementia Rating
Time frame: 12 months
The median change in the score at 12 months on the Clinical Dementia Rating-Sum of Boxes (CDR-SB; range, 0 to 18, with higher scores indicating greater impairment) between groups looking for regression to higher levels of cognition or conversion to more severe dementia

Sponsor's own description

Oral supplementation of histidine in patients with cognitive dysfunction should increase brain anserine, carnosine and histamine levels which will result in improved cognition via numerous proven in vivo mechanisms including increasing blood flow, neurogenesis, angiogenesis, activation of histaminergic neural pathways and autophagy of beta-amyloid protein, which is pathognomonic for Alzheimer's disease. Randomized into one of 2 arms to receive Histidine or placebo to take for up to 3 months. Baseline evaluation and followup evaluation at 3 months postop.

Publications & conference data

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

Therapeutic Effects of Taurine and Histidine Supplementation in Retinal Diseases.
Lee D, Smith LEH. · · 2024 · cited 4× · PMID 39768274 · DOI 10.3390/life14121566
Bridging the computational-experimental gap: leveraging large language model to prioritize Alzheimer's therapeutics based on comparison of learning models.
Li M, Niu S, Xu Y, Li J, et al · · 2026 · PMID 41768541 · DOI 10.1038/s44401-026-00074-3

Verify or expand the search:

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Other Wake Forest University Health Sciences trials

Trials by the same sponsor.

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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 NCT06169826 (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 Wake Forest University Health Sciences
Last refreshed: 23 April 2025

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/NCT06169826.

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