Last reviewed · How we verify
NCT05880849
Choline Effects - Pre-symptomatic AD
Phase 1 trial testing Choline in Alzheimer Disease in 15 participants. Completed in 10 October 2025.
1 July 2025
Quick facts
| Lead sponsor | Paul E Schulz |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 26 June 2023 |
| Primary completion | 1 July 2025 |
| Estimated completion | 10 October 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Choline (Choline) — full drug profile →
Conditions studied
- Alzheimer Disease — all drugs for Alzheimer Disease →
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):
-
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 -
Lipids as Emerging Biomarkers in Neurodegenerative Diseases.
Wei J, Wong LC, Boland S. · · 2023 · cited 46× · PMID 38203300 · DOI 10.3390/ijms25010131 -
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 -
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 -
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:
- PubMed search for NCT05880849
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Choline
Trials testing the same drug.
- NCT06379971 — Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development · Phase 1 · recruiting
- NCT06924541 — Choline Dose Ranging in Postmenopausal Women · NA · recruiting
- NCT05076682 — Reverse Triple Negative Immune Resistant Breast Cancer · Phase 2 · recruiting
- NCT07264257 — Choline and Brain Functioning in Postmenopausal Women · NA · completed
- NCT04764162 — Choline and Cardiometabolic Health · NA · completed
Other recruiting trials for Alzheimer Disease
Currently open trials in the same condition.
- NCT07290387 — Tele-Savvy for Latino Caregivers · NA · recruiting
- NCT07178210 — Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease · NA · recruiting
- NCT07294885 — Deep Cervical LymphatIc-Venous Anastomosis for Alzheimer's Disease · NA · recruiting
- NCT06937229 — A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3) · Phase 3 · recruiting
- NCT06930560 — HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05880849 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Paul E Schulz
- Last refreshed: 2 February 2026
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