Could a Vitamin-Like supplement ward off Alzheimer's in High-Risk individuals?
NCT ID NCT05880849
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed phase 1 study tested whether taking choline, a dietary supplement, for 6 months could improve fat metabolism in the brain of people with the APOE4 gene, which raises Alzheimer's risk. Fifteen participants aged 55-80 took choline capsules twice daily. The main goal was to check safety and see if choline changes certain fat-related markers in spinal fluid. This early trial focuses on biological effects, not on preventing or treating Alzheimer's symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- choline (a dietary supplement)
- What this could lead to
- If it works, this could point toward a simple dietary supplement to help delay or prevent Alzheimer's in people with the APOE4 gene.
- What could go wrong
- This is a very early, small phase 1 trial with only 15 people. It mainly checks safety and biological changes, not whether choline actually prevents Alzheimer's. The results may not lead to a proven treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
15 people
The number who actually took part.
- Started
-
Jun 2023
- Finished
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Oct 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 to 80 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Has signed an informed consent form before any assessment is performed as part of the study. 2. Be male or female between 55 and 80 years old. 3. Be able to understand the nature of the study and have the opportunity to have all questions answered. 4. Has tested positive for at least one copy of ApoE4. 5. Has an MMSE score of 24 or greater. (can be based on documented result obtained within the previous 3 months). 6. Is in the opinion of the Investigator, in good general medical health based upon medical history, physical examination, laboratory tests, vital signs and EKG. 7. Has normal levels of Homocysteine in blood tests. A normal blood level is between 5 to 15 micromoles (mcmol/L) 8. Completes the dietary interview with dietician. 9. Females must be considered post-menopausal or not of child bearing potential. Exclusion Criteria: 1. Current medical or neurological condition that might impact cognition or performance on cognitive assessments. (e.g. TBI, Parkinson's disease, multiple sclerosis, etc.) 2. Inability or unwillingness of patient to undergo neuropsychological testing. 3. 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.) 4. History of malignancy of any organ system, treated or untreated, within the past 60 months. 5. Inability or unwillingness to undergo Lumbar Punctures. 6. High dietary choline intake (more than 450mg) as determined by dietician 7. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The University of Texas Health Science Center at Houston (UTHealth)
Houston, Texas, 77054, United States
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