COMPLETED

Choline Effects - Pre-symptomatic AD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Testing Whether Choline Normalizes Lipid Metabolism in APOE4 Carriers

Quick Facts

Study Start:2023-06-26

Study Completion:2025-10-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05880849

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Paul E Schulz, MD

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at Houston (UTHealth)

Study Locations (Sites)

The University of Texas Health Science Center at Houston (UTHealth)

Houston, Texas, 77054

United States

Collaborators and Investigators

Sponsor: Paul E Schulz

Paul E Schulz, MD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center at Houston (UTHealth)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-26

Study Completion Date2025-10-10

Study Record Updates

Study Start Date2023-06-26

Study Completion Date2025-10-10

Terms related to this study

Keywords Provided by Researchers

pre-symptomatic AD

Additional Relevant MeSH Terms

Alzheimer Disease