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Dietary Supplement

Choline for Alzheimer's Disease

Phase 1

Recruiting

Led By Paul E Schulz, MD

Research Sponsored by Paul E Schulz

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Awards & highlights

Study Summary

This trial is testing if a dietary supplement, choline, could help slow down the progression of Alzheimer's Disease in those at risk.

Who is the study for?

This trial is for adults aged 55-80 who are at risk of Alzheimer's but not yet showing symptoms. They must have a certain gene variant (ApoE4), normal thinking skills, and good general health based on medical exams. Women should be post-menopausal or unable to bear children. People with other serious diseases, high choline diets, or unwillingness to undergo certain tests can't join.Check my eligibility

What is being tested?

The study is examining the safety and potential effects of choline—a dietary supplement—on individuals who are at increased risk for Alzheimer's Disease but do not yet show symptoms. The goal is to see if choline influences the progression towards Alzheimer's.See study design

What are the potential side effects?

As a dietary supplement, choline is generally considered safe; however, possible side effects in the context of this trial may include digestive issues like nausea or diarrhea, fishy body odor when taken in large amounts, and potentially low blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in phosphatidylcholine (PC) in the CSF following choline supplementation

Changes in the fatty acid desaturation index (FADI) in the CSF following choline supplementation

Secondary outcome measures

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

Changes in choline in blood following choline supplementation

Changes in neurofilament light chain (Nf-L) in CSF following choline supplementation

+5 more

Other outcome measures

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

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

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

Side effects data

From 2014 Phase 4 trial • 60 Patients • NCT01749982

13%

Diarrhea

13%

Fever

Chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Choline Bitartrate

Betaine

Choline Bitartrate + Betaine

Trial Design

1Treatment groups

Experimental Treatment

Group I: CholineExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Choline

2015

Completed Phase 3

~560

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Paul E SchulzLead Sponsor

M.D. Anderson Cancer CenterOTHER

2,974 Previous Clinical Trials

1,789,455 Total Patients Enrolled

Massachusetts Institute of TechnologyOTHER

97 Previous Clinical Trials

12,729,973 Total Patients Enrolled

Media Library

Choline (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05880849 — Phase 1

Alzheimer's Disease Research Study Groups: Choline

Alzheimer's Disease Clinical Trial 2023: Choline Highlights & Side Effects. Trial Name: NCT05880849 — Phase 1

Choline (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05880849 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I qualified to be a participant in this research project?

"Qualified participants for this clinical trial must be diagnosed with alzheimer's and within the ages of 55 to 80. A maximum of 14 individuals are eligible to join."

Answered by AI

How hazardous is the consumption of Choline for individuals?

"Choline is currently in Phase 1 clinical trials, so it has been granted a score of 1 based on the limited amount of data surrounding its safety and efficacy."

Answered by AI

Are participants over 40 being accepted into this experiment?

"This trial seeks applicants ages 55 to 80 for inclusion. Separately, there are 18 trials seeking younger individuals and 521 studies recruiting seniors aged 65 or above."

Answered by AI

How many people have been admitted for participation in this clinical experiment?

"Affirmative, according to clinicaltrials.gov, this research is currently in recruitment mode. This trial was initially made available on May 1st 2023 and most recently updated on the 25th of May 2023; it requires 14 participants from a solitary site."

Answered by AI

Are there presently any opportunities to enroll in this research?

"Indeed, the information hosted on clinicaltrials.gov suggests this medical trial is currently accepting applicants. It was initially posted in May 1st 2023 and has been recently updated on 25th of that same month. The study requires 14 participants from a single site to move forward."

Answered by AI

What are the key aims of this clinical exploration?

"The primary goal of this clinical trial, to be measured over a baseline and 6 month period is the alteration of phosphatidylcholine (PC) concentrations in cerebrospinal fluid following choline supplementation. Other objectives encompass variations in CSF phospholipids, blood PC levels, and finally, changes to choline concentration within the bloodstream; all results will be compiled as aggregate values and percentages."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Choline Effects - Pre-symptomatic AD

Paul E Schulz 2023. "Choline Effects - Pre-symptomatic AD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05880849.

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