Testing Whether Choline Normalizes Lipid Metabolism in APOE4 Carriers
NCT: NCT05880849 ·
Status: COMPLETED ·
Phase: Phase 1
· Sponsor: Paul E Schulz
· Started: 2023-06-26
· Est. Completion: 2025-10-10
Official Summary
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.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 15 participants
Interventions
- DRUG: Choline — Eight 275mg capsules taken orally twice daily (4 capsules with breakfast \& 4 capsules with dinner) x 180 days
Primary Outcomes
- Changes in the fatty acid desaturation index (FADI) in the CSF following choline supplementation (baseline, 6 months)
- Changes in phosphatidylcholine (PC) in the CSF following choline supplementation (baseline, 6 months)
Secondary Outcomes
- Number of participants with treatment-related adverse events (9 months)
- Changes in phospholipids in CSF following choline supplementation (Baseline and 6 months)
- Changes in phosphatidylcholine in blood following choline supplementation (Baseline and 6 months)
- Changes in choline in blood following choline supplementation (Baseline and 6 months)
- Changes in proinflammatory cytokines in blood plasma following choline supplementation (Baseline and 6 months)
Trial Locations
- The University of Texas Health Science Center at Houston (UTHealth), Houston, Texas, United States
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AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.