Choline Effects - Pre-symptomatic AD

NCT05880849 | Completed Phase 1 FDA Drug

• 1 other identifier: HSC-MS-22-0637
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease

Keywords

pre-symptomatic AD

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (11)

• 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 pTau181/Ab42 ratio in CSF following choline supplementation

  Baseline and 6 months

Other Outcomes (3)

• Change in Mini-Mental Status Examination (MMSE) following choline supplementation

  Baseline and 6 months

• Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores following choline supplementation

  Baseline and 6 months

• Change in Functional Activities Questionnaire (FAQ) scores following choline supplementation

  Baseline and 6 months

Study Arms (1)

Choline

EXPERIMENTAL

2.2 g of choline, given as choline bitartrate, for a total of 180 days.

Drug: Choline

Interventions

Choline DRUG

Eight 275mg capsules taken orally twice daily (4 capsules with breakfast \& 4 capsules with dinner) x 180 days

Also known as: Choline Bitartrate, VitaCholine(R)

Choline

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has signed an informed consent form before any assessment is performed as part of the study.
• Be male or female between 55 and 80 years old.
• Be able to understand the nature of the study and have the opportunity to have all questions answered.
• Has tested positive for at least one copy of ApoE4.
• Has an MMSE score of 24 or greater. (can be based on documented result obtained within the previous 3 months).
• Is in the opinion of the Investigator, in good general medical health based upon medical history, physical examination, laboratory tests, vital signs and EKG.
• Has normal levels of Homocysteine in blood tests. A normal blood level is between 5 to 15 micromoles (mcmol/L)
• Completes the dietary interview with dietician.
• Females must be considered post-menopausal or not of child bearing potential.

You may not qualify if:

• Current medical or neurological condition that might impact cognition or performance on cognitive assessments. (e.g. TBI, Parkinson's disease, multiple sclerosis, etc.)
• Inability or unwillingness of patient to undergo neuropsychological testing.
• 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.)
• History of malignancy of any organ system, treated or untreated, within the past 60 months.
• Inability or unwillingness to undergo Lumbar Punctures.
• High dietary choline intake (more than 450mg) as determined by dietician
• 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.

Sponsors & Collaborators

• Paul E Schulz: lead
• M.D. Anderson Cancer Center: collaborator
• Massachusetts Institute of Technology: collaborator
• Balchem Corporation: collaborator

Study Sites (1)

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

Houston, Texas, 77054, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Choline

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds

Study Officials

• Paul E Schulz, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Neurology

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 30, 2023
• Study Start: June 26, 2023
• Primary Completion: July 1, 2025
• Study Completion: October 10, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)