Alzheimer Disease Clinical Trial
Official title:
Testing Whether Choline Normalizes Lipid Metabolism in APOE4 Carriers
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.
Status | Recruiting |
Enrollment | 14 |
Est. completion date | June 2026 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Health Science Center at Houston (UTHealth) | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Paul E Schulz | Balchem Corporation, M.D. Anderson Cancer Center, Massachusetts Institute of Technology |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Mini-Mental Status Examination (MMSE) following choline supplementation | Cognition measured by MMSE. Scoring: 24-30 no cognitive impairment; 18-23 mild cognitive impairment; 0-17 severe cognitive impairment. | Baseline and 6 months | |
Other | Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores following choline supplementation | Cognitive decline measured by RBANS. Total Score subtest ranges: List Learning (0-40); Story Memory (0-24); Figure Copy (0-20); Line Orientation (0-20); Picture Naming (0-10); Semantic Fluency (4-40); Digit Span (0-16); Coding (0-89); List Recall (0-10); List Recognition (0-20); Story Recall (0-12); Figure Recall (0-20). Use Stimulus Booklet to convert Total Scores to Index Scores and Sum of Index Scores to Total Scale. Total Scores can range from 40 to 160. The RBANS scores are displayed as standard scores with means of 100 and a standard deviation of 15. Average/Mild Impairment (standard scores of 70 or above), Moderate Impairment (standard scores from 55 to 69), and Severe Impairment (standard scores <54). | Baseline and 6 months | |
Other | Change in Functional Activities Questionnaire (FAQ) scores following choline supplementation | Measure instrumental activities of daily living (IADLs) by FAQ. Sum scores (range 1-30). Cut-point of 9 (dependent in 3 or more activities) is recommended to indicate impaired function and possible cognitive impairment. | Baseline and 6 months | |
Primary | Changes in the fatty acid desaturation index (FADI) in the CSF following choline supplementation | FADI will be utilized to determine whether unsaturated to saturated lipids decreases by 15% | baseline, 6 months | |
Primary | Changes in phosphatidylcholine (PC) in the CSF following choline supplementation | FADI ( fatty acid desaturation index) will be utilized to determine whether saturated PC increases by 100% | baseline, 6 months | |
Secondary | Number of participants with treatment-related adverse events | Safety endpoints will be monitored throughout the study and number of incidents reported at end of study. Aggregate values and percentages will be reported | 9 months | |
Secondary | Changes in phospholipids in CSF following choline supplementation | Will compare scaled intensity between baseline and 6 months. | Baseline and 6 months | |
Secondary | Changes in phosphatidylcholine in blood following choline supplementation | Aggregate values and percentages will be reported. | Baseline and 6 months | |
Secondary | Changes in choline in blood following choline supplementation | Aggregate values and percentages will be reported | Baseline and 6 months | |
Secondary | Changes in proinflammatory cytokines in blood plasma following choline supplementation | Proinflammatory cytokine panel in plasma will be measured using commercially available immunosorbent assays to determine potential treatment effects. Aggregate values and percentages will be reported. Each sample will be tested in triplicate. | Baseline and 6 months | |
Secondary | Changes in neurofilament light chain (Nf-L) in CSF following choline supplementation | Levels of NfL in CSF will be measured using commercially available immunosorbent assays to determine potential treatment effects. Aggregate values and percentages will be reported. Each sample will be tested in triplicate. | Baseline and 6 months | |
Secondary | Changes in amyloid-ß 42/40 ratio CSF following choline supplementation | Levels of amyloid-ß 42/40 ratio in CSF will be measured by LC/MS/MS assays. Aggregate values and percentages will be reported. | Baseline and 6 months | |
Secondary | Changes in p-Tau/Total Tau ratio in CSF following choline supplementation | Levels of p-Tau/Total Tau will be measured by LC/MS/MS assays. Aggregate values and percentages will be reported. | Baseline and 6 months |
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