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NCT05880849

Choline Effects - Pre-symptomatic AD

Completed Phase 1 Last updated 2 February 2026
What this trial tests

Phase 1 trial testing Choline in Alzheimer Disease in 15 participants. Completed in 10 October 2025.

Timeline
26 June 2023
Primary endpoint
1 July 2025
10 October 2025

Quick facts

Lead sponsorPaul E Schulz
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment15
Start date26 June 2023
Primary completion1 July 2025
Estimated completion10 October 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Paul E Schulz — full company profile →

Who can join

Adults 55 to 80, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to test the safety, tolerability, and effects of choline in people with increased risk of Alzheimer's Disease (AD), also known as pre-symptomatic AD. Choline is a dietary supplement, but is being investigated to see if it has any effects on the progression to AD.

Publications & conference data

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

  1. 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
  2. Lipids as Emerging Biomarkers in Neurodegenerative Diseases.
    Wei J, Wong LC, Boland S. · · 2023 · cited 46× · PMID 38203300 · DOI 10.3390/ijms25010131
  3. The Energetic Collapse of the Alzheimer's Brain: Metabolic Inflexibility Across Cells and Networks.
    Constantino NJ, Ashley CC, Macauley SL. · · 2025 · cited 2× · PMID 41231438 · DOI 10.1111/jnc.70294
  4. Alzheimer's disease drug development pipeline: 2026.
    Cummings JL, Zhou Y, Yang Y, Zhong K, et al · · 2026 · PMID 42095064 · DOI 10.1002/trc2.70251
  5. Vitamin deficiencies and Alzheimer's disease: evidence and implications for supplementation.
    Miteva MT, Laurenti D, Mattioli R, Di Risola D, et al · · 2026 · PMID 41769656 · DOI 10.3389/fnut.2026.1676497

Verify or expand the search:

Other trials of Choline

Trials testing the same drug.

Other recruiting trials for Alzheimer Disease

Currently open trials in the same condition.

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Data sources for this page

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/NCT05880849.

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