NCT05880849CompletedPhase 1
Choline Effects - Pre-symptomatic AD
Testing Whether Choline Normalizes Lipid Metabolism in APOE4 Carriers
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 10 May 2023
- Start date
- 26 Jun 2023
- Primary completion date
- 1 Jul 2025
- Lead sponsor
- Paul E Schulz
- Diseases
- Alzheimer disease
- NCT number
- NCT05880849
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 15
- From 26 Jun 2023 to the primary completion date, 1 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any condition, which in the opinion of the investigator, would put the subject at undue risk or would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
Other illness
- Current medical or neurological condition that might impact cognition or performance on cognitive assessments. (e.g. TBI, Parkinson's disease, multiple sclerosis, etc.)
- Advanced, severe progressive or unstable disease that may interfere with the safety, tolerability and study assessments, or put the participant at special risk. (e.g. significant cardiac disease, severe renal impairment, severe hepatic impairment etc.)
- History of malignancy of any organ system, treated or untreated, within the past 60 months.
Other
- Inability or unwillingness of patient to undergo neuropsychological testing.
- Inability or unwillingness to undergo Lumbar Punctures.
- High dietary choline intake (more than 450mg) as determined by dietician
Who the study is looking for
- Has signed an informed consent form before any assessment is performed as part of the study.
- Be male or female between 55 and 80 years old.
- Be able to understand the nature of the study and have the opportunity to have all questions answered.
- Has tested positive for at least one copy of ApoE4.
- Has an MMSE score of 24 or greater. (can be based on documented result obtained within the previous 3 months).
- Is in the opinion of the Investigator, in good general medical health based upon medical history, physical examination, laboratory tests, vital signs and EKG.
- Has normal levels of Homocysteine in blood tests. A normal blood level is between 5 to 15 micromoles (mcmol/L)
- Completes the dietary interview with dietician.
- Females must be considered post-menopausal or not of child bearing potential.
Age in the registry: 55 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Texas Health Science Center at Houston (UTHealth) Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.