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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT05880849

NCT05880849
Completed Phase 1

Who may be able to join

Who might be able to join this trial:

  • You have signed a consent form before any study assessments begin.
  • You are male or female, aged between 55 and 80 years old.
  • You are able to understand what the study involves and have had the chance to ask questions.
  • You have tested positive for at least one copy of a gene variant called ApoE4.
  • You have scored 24 or higher on a standard memory and thinking test called the MMSE (a result from the past 3 months may be accepted).
  • In the doctor's opinion, you are in generally good health based on your medical history, physical exam, blood tests, and heart tests.
  • Your blood test shows a normal level of a substance called homocysteine (between 5 and 15 mcmol/L).
  • You have completed a diet interview with a dietician as part of the study process.
  • If you are female, you must be post-menopausal or not able to become pregnant.

Who may not be able to join:

  • You have a current medical or neurological condition (such as a brain injury, Parkinson's disease, or multiple sclerosis) that could affect memory or thinking tests.
  • You are unable or unwilling to take part in memory and thinking assessments.
  • You have a serious, advanced, or unstable illness (such as significant heart disease or severe kidney or liver problems) that could affect your safety or the study results.
  • You have been diagnosed with any form of cancer in the past 5 years, whether treated or not.
  • You are unable or unwilling to have a lumbar puncture (a procedure where a small sample of fluid is taken from your lower back).
  • Your diet includes a high amount of choline (more than 450mg per day), as assessed by the dietician.
  • The doctor believes, for any other reason, that joining the trial could put you at unnecessary risk or affect the study results (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 1
Sponsor
Paul E Schulz
Registry
clinicaltrials_gov
Start date
26 June 2023
Est. completion
1 July 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Changes in the fatty acid desaturation index (FADI) in the CSF following choline supplementation; Changes in phosphatidylcholine (PC) in the CSF following choline supplementation

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov