NCT05880849 · Phase 1 · COMPLETED
Choline Effects - Pre-symptomatic AD
This Phase 1 trial is testing whether choline — a common dietary supplement — is safe and tolerable in people who carry the APOE4 gene and show no symptoms of Alzheimer's yet. Phase 1 means the focus is on safety and dosing, not proving it works. Researchers are also watching for any early signals of effect on Alzheimer's progression. It is a small, early-stage study.
You may qualify if
- 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.
You're excluded if
- Current medical or neurological condition that might impact cognition or performance on cognitive assessments. (e.g. TBI, Parkinson's disease, multiple sclerosis, etc.)
- Inability or unwillingness of patient to undergo neuropsychological testing.
- 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.
- Inability or unwillingness to undergo Lumbar Punctures.
- High dietary choline intake (more than 450mg) as determined by dietician
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-02-02