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Alzheimer DiseasePhase 1NCT05880849

Choline Effects - Pre-symptomatic AD

A Phase 1 study testing Choline in people with Alzheimer Disease, run by Paul E Schulz at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 80 years
Conditions the study is for
Alzheimer Disease
What is being tested?
Choline
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
26 Jun 2023to 10 Oct 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Houston, Texas, 77054

Other trials in United States

About this study

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.

Read the detailed description

The purpose of this study is to determine the safety and tolerability, as well as the biochemical effects of choline bitartrate over a 6-month treatment period in a moderately sized population harboring at least one copy of the APOE4 gene. APOE is a protein involved in lipid transport. Studies show that the APOE4 variant is strongly associated with an increased risk of Alzheimer's Disease. It is unclear how APOE4 results in an increased risk for AD, but a recent study identified a novel molecular pathway, which showed that APOE4-induced dysfunction of lipid metabolism in neurons by cellular accumulation of unsaturated lipids. The investigators hypothesize that choline supplementation normalizes the APOE4-mediated dysregulation by normalizing the Kennedy pathway in neuronal cells, thus stabilizing the lipid metabolism and concomitantly restoring normal cell function by increasing phosphatidylcholine activity via the Kennedy pathway. To evaluate this, the investigators will test if choline supplementation will decrease the ratio of unsaturated lipids to saturated lipids (the fatty acid desaturation index) in cerebrospinal fluid by 15% and increase phosphatidylcholine by 100%.

Being tested
Choline
Keywords
pre-symptomatic AD
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CholineDrug

    Also called Choline Bitartrate, VitaCholine(R)

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

Study groups in NCT05880849
Study groupRoleWhat they receive
CholineExperimental2.2 g of choline, given as choline bitartrate, for a total of 180 days.
Receives: Drug: Choline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%

    Measured: baseline, 6 months

  2. 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%

    Measured: baseline, 6 months

Secondary outcomes (11)

  1. 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

    Measured: 9 months

  2. Changes in phospholipids in CSF following choline supplementation

    Will compare scaled intensity between baseline and 6 months.

    Measured: Baseline and 6 months

  3. Changes in phosphatidylcholine in blood following choline supplementation

    Aggregate values and percentages will be reported.

    Measured: Baseline and 6 months

  4. Changes in choline in blood following choline supplementation

    Aggregate values and percentages will be reported

    Measured: Baseline and 6 months

  5. Changes in pTau181/Ab42 ratio in CSF following choline supplementation

    Levels of pTau181 and Ab42 in CSF will be measured using commercially available immunosorbent assays to determine potential treatment effects. Ratios will be reported.

    Measured: Baseline and 6 months

  6. Changes in pTau217 in plasma following choline supplementation

    Levels of pTau217 in plasma will be measured using commercially available immunosorbent assays to determine potential treatment effects. Fold change will be reported.

    Measured: Baseline and 6 months

  7. Changes in betaine in plasma following choline supplementation

    Levels of betaine in plasma will be measured using LC/MS/MS to determine potential treatment effects. Fold changes will be reported.

    Measured: Baseline and 6 months

  8. Changes in betaine in CSF following choline supplementation

    Levels of betaine in CSF will be measured using LC/MS/MS to determine potential treatment effects. Fold changes will be reported.

    Measured: Baseline and 6 months

  9. 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.

    Measured: Baseline and 6 months

  10. Changes in amyloid-β 42/40 ratio CSF following choline supplementation

    Levels of amyloid-β 42/40 ratio in CSF will be measured by LC/MS/MS assays. Aggregate values and percentages will be reported.

    Measured: Baseline and 6 months

  11. 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.

    Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2023
  2. Study start26 Jun 2023
  3. Primary completion1 Jul 2025
  4. Study completion10 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05880849
Sponsor's protocol ID
HSC-MS-22-0637
Status last verified
Apr 2026
First submitted
10 May 2023
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Choline in people with Alzheimer Disease, run by Paul E Schulz at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the fatty acid desaturation index (FADI) in the CSF following choline supplementation (time frame: baseline, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05880849.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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