What side effects are associated with this type of intervention?

The most common treatments for Alzheimer's Disease that enhance cognitive function by supporting acetylcholine synthesis are cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and memantine. Cholinesterase inhibitors can cause side effects such as nausea, vomiting, diarrhea, muscle cramps, and increased risk of gastrointestinal bleeding. Memantine, which is often used in combination with cholinesterase inhibitors, can cause dizziness, headache, confusion, and constipation. Both classes of drugs are generally well-tolerated but require monitoring for these potential side effects.

What prior FDA approvals exist?

FDA-approved treatments for Alzheimer's Disease that enhance cognitive function by supporting acetylcholine synthesis include cholinesterase inhibitors such as donepezil, rivastigmine, and galantamine. These drugs work by inhibiting cholinesterase, thereby increasing cholinergic transmission at the synaptic cleft. Another related drug is memantine, which is often used in combination with cholinesterase inhibitors for moderate to severe Alzheimer's Disease. These treatments provide modest symptomatic benefits in cognition and global functioning.

What other types of research exist?

Promising novel alternatives to choline for Alzheimer's Disease patients include: <ol> <li>Aducanumab: Approved by the FDA for mild AD, it reduces brain amyloid levels, though clinical benefits are uncertain and it requires close monitoring.</li> <li>Vitamin E: May provide modest benefits in slowing disease progression in mild to moderate AD, though its use is debated among experts.</li> <li>Cholinesterase Inhibitors: Such as donepezil, rivastigmine, and galantamine, which provide modest symptomatic benefits in cognition and global functioning.</li> <li>Investigational Therapies: Various potential therapies are being evaluated in early clinical trials, showing promise in animal models.</li> </ol>

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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

No Placebo-Only Group

Summary

This trial tests if choline bitartrate, a dietary supplement, can help people at risk of Alzheimer's Disease. The supplement aims to improve how brain cells handle fats, potentially keeping them healthy and functioning properly.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2021

Completed Phase 4

~630

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Alzheimer's Disease, such as cholinesterase inhibitors (donepezil, rivastigmine, and galantamine), work by inhibiting the enzyme that breaks down acetylcholine, thereby increasing its levels in the brain. This enhancement of cholinergic transmission helps improve cognitive functions like memory and learning, which are typically impaired in Alzheimer's patients. Similarly, choline, an investigational treatment, supports acetylcholine synthesis, potentially offering another avenue to boost cognitive function. These treatments are crucial as they aim to alleviate the symptoms of Alzheimer's by addressing the neurotransmitter deficits that contribute to cognitive decline.