Choline Effects - Pre-symptomatic AD

Launched by PAUL E SCHULZ · May 25, 2023

Keywords

ClinConnect Summary

This clinical trial, called "Choline Effects - Pre-symptomatic AD," is exploring the safety and effects of a dietary supplement called choline in people who are at higher risk for developing Alzheimer’s Disease (AD). The trial is currently looking for participants aged 55 to 80 who have tested positive for a specific gene (ApoE4) associated with Alzheimer's. To be eligible, participants should be in generally good health and have a certain level of cognitive function, as measured by a brief mental assessment.

If you or a family member are interested in participating, you would need to sign a consent form and complete a dietary interview. Participants will be monitored throughout the study to ensure their safety and to see if choline has any effects on slowing down the progression towards Alzheimer’s. It's important to note that certain health conditions or high choline intake may prevent someone from joining the trial. This study aims to gather more information on how choline might help those at risk for Alzheimer's, which could ultimately lead to better prevention strategies.

Gender

ALL

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.