Effects of choline on people at risk for Alzheimer's Disease

Testing Whether Choline Normalizes Lipid Metabolism in APOE4 Carriers

This study is testing if choline supplements can help people aged 55 to 80 who are at risk for Alzheimer's due to a specific gene by looking at how it affects certain fats in their brain fluid.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Ages: 55 Years to 80 Years
• Sex: All
• Sponsor: The University of Texas Health Science Center, Houston (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05880849 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety, tolerability, and biochemical effects of choline bitartrate in individuals aged 55 to 80 who carry at least one copy of the APOE4 gene, which is linked to an increased risk of Alzheimer's Disease. Over a 6-month treatment period, participants will receive choline supplementation to assess its impact on lipid metabolism in neuronal cells. The primary goal is to determine if choline can decrease the ratio of unsaturated to saturated lipids in cerebrospinal fluid and increase phosphatidylcholine levels. The study will involve a moderately sized population and will include comprehensive assessments to ensure participant eligibility and safety.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 55 to 80 who have tested positive for the APOE4 gene and have a Mini-Mental State Examination (MMSE) score of 24 or greater.

Not a fit: Patients with current medical or neurological conditions that could affect cognition or performance on cognitive assessments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new dietary intervention to slow or prevent the progression of Alzheimer's Disease in at-risk individuals.

How similar studies have performed: While the approach of using choline supplementation in this context is novel, previous studies have explored lipid metabolism in relation to Alzheimer's Disease, indicating potential pathways for success.

Eligibility criteria

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.

Where this trial is running

Houston, Texas

• The University of Texas Health Science Center at Houston (UTHealth) — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Paul E Schulz, MD — The University of Texas Health Science Center at Houston (UTHealth)
• Study coordinator: Kristofer Harris, RN

Conditions Alzheimer Disease; pre-symptomatic AD