Citicoline Supplement for Alzheimer's Disease

No longer recruiting at 1 trial location

Overseen By Victoria Pak, PhD, MS, MTR

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Epilepsy, Head trauma, COPD, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a citicoline supplement can improve sleep and thinking skills in people with Alzheimer's disease. Previous studies suggest citicoline might help with memory issues. This trial aims to determine if it can also address sleep problems, which affect many with Alzheimer's and their caregivers. Participants will receive either the citicoline supplement or a placebo (a substance with no active ingredients). Ideal candidates for this trial are those diagnosed with Alzheimer's disease, living in the continental U.S., and experiencing sleep disturbances.

As an unphased trial, participants can contribute to groundbreaking research that could enhance the quality of life for those with Alzheimer's.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that citicoline, a dietary supplement, is safe and well-tolerated. Studies found that people with Alzheimer's disease who took citicoline experienced no serious side effects. Citicoline has been safely used in various groups of people with Alzheimer's at the same dose as in this trial. It is also known for effectively reaching the brain. Overall, evidence suggests that citicoline is safe for people, particularly those with Alzheimer's disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Alzheimer's disease, which often focus on managing symptoms with medications like Donepezil or Memantine, the citicoline supplement is unique because it targets the brain's cellular health. Citicoline is a naturally occurring compound that supports the brain's phospholipid synthesis, potentially enhancing neuronal repair and function. Researchers are excited about this treatment because it offers a novel mechanism of action that could not only slow cognitive decline but also improve overall brain health, which current options do not directly address.

What evidence suggests that this citicoline supplement might be an effective treatment for Alzheimer's disease?

Research shows that citicoline can help with brain health. Studies have found that citicoline improves memory and mental clarity, especially in older adults. In this trial, participants with Alzheimer's disease will receive either a citicoline supplement or a placebo. Treatments including citicoline have effectively boosted brain function. Citicoline is also safe, with studies showing it is well tolerated by Alzheimer's patients. While this study examines how citicoline might improve sleep, existing evidence supports its role in enhancing brain function. ^{2 4 5 6 7}

Who Is on the Research Team?

Victoria Pak, PhD, MS, MTR

Principal Investigator

Emory School of Nursing, School of Public Health

Are You a Good Fit for This Trial?

This trial is for adults with Alzheimer's Disease living in the continental U.S. who can read English and have internet access. It excludes those with severe health issues like heart failure, diabetes type I, liver cirrhosis; psychiatric disorders; sleep apnea; or a history of substance abuse.

Inclusion Criteria

I am 18 or older and live in the continental US.

I have been diagnosed with Alzheimer's disease, confirmed by my medical records.

Have Internet and email access (this criterion applies to the legally authorized representatives)

Exclusion Criteria

You have a history of depending too much on alcohol or misusing medications.

No telephone access

I have a chronic condition like heart failure, diabetes, or arthritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either citicoline or placebo for 3 months

12 weeks

Baseline visit (T0), Follow-up visit (T1) at 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Citicoline supplement
• Placebo

Trial Overview

The study tests if a citicoline dietary supplement improves sleep and cognition in Alzheimer's patients compared to a placebo. Citicoline has shown promise in previous studies for cognitive decline and is considered well-tolerated.

How Is the Trial Designed?

Group I: Citicoline Supplement Experimental Treatment 1 Intervention

Participants with AD will receive a dietary citicoline supplement

Group II: Placebo Placebo Group 1 Intervention

Participants with AD will receive a placebo supplement

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Emory Goizueta Alzheimer's Disease Research Center (ADRC)

Collaborator

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Goizueta Alzheimer's Disease Research Center (ADRC)

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

In a study of 79 patients with probable Alzheimer's disease, THA (tetrahydroaminoacridine) showed a trend towards improved cognitive function compared to placebo, although the results did not reach statistical significance.

Despite some safety concerns leading to withdrawals due to elevated liver enzymes and cholinergic side effects, THA was associated with a higher rate of improvement in cognitive scores, with three to four times as many patients showing significant improvement on the MMSE compared to those on placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of the efficacy and safety of tetrahydroaminoacridine (THA) without lecithin in the treatment of Alzheimer's disease. Wilcock, GK., Surmon, DJ., Scott, M., et al.[2019]

In a 24-week study involving patients with mild to moderate Alzheimer's disease, those treated with rivastigmine (both patch and capsule forms) showed significantly more sustained cognitive and daily living improvements compared to placebo, with 24% to 36% of patients achieving notable enhancements.

Predictive factors for a sustained response to rivastigmine included baseline cognitive scores and the duration since the first diagnosis, which can help tailor treatment plans and set realistic expectations for patients and caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of sustained response to rivastigmine in patients with Alzheimer's disease: a retrospective analysis. Sadowsky, CH., Grossberg, GT., Somogyi, M., et al.[2021]

Cholinesterase inhibitors are currently the only approved medications for treating cognitive deficits in Alzheimer's disease, showing efficacy in clinical trials by compensating for the loss of acetylcholine.

Antioxidant drugs like alpha-tocopherol (vitamin E) and selegiline have shown marginal benefits over placebo in slowing functional decline in patients with moderately advanced Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacologic approaches to cognitive deficits in Alzheimer's disease. Peskind, ER.[2018]

In a long-term study involving 14 patients with probable Alzheimer's disease, oral physostigmine therapy showed significant improvements in memory test scores compared to placebo, with some patients experiencing up to a 50% improvement.

The results suggest that long-term administration of physostigmine may be more effective than short-term treatment, with benefits potentially sustained for up to a year in many patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term administration of oral physostigmine in Alzheimer's disease. Stern, Y., Sano, M., Mayeux, R.[2019]

Anticholinesterase drugs, such as donepezil and rivastigmine, provide significant cognitive benefits for patients with mild-to-moderate Alzheimer's disease, although they can cause side effects in 5% to 15% of cases, including nausea and dizziness.

Memantine, an NMDA receptor antagonist, offers an alternative treatment for moderately severe to severe Alzheimer's disease by protecting neurons from harmful glutamate activity while supporting normal neurotransmitter function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of cognitive impairment in Alzheimer's disease. Burns, A.[2021]

In a study involving 10 Alzheimer's disease (AD) patients, intravenous physostigmine improved reaction times and increased blood flow in the brain, suggesting a potential therapeutic effect on cognitive function.

Another study with 17 AD patients showed that treatment with tetrahydroaminoacridine (THA) alone or combined with lecithin over 26 weeks resulted in varying responses, indicating that some patients benefited while others did not, as measured by brain activity and cognitive tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physostigmine and tetrahydroaminoacridine treatment of Alzheimer's disease. Gustafson, L.[2019]

Tacrine, approved in 1995 for mild to moderate Alzheimer's disease, can improve cognitive functions and behavioral issues in many patients, showing its efficacy as a symptomatic treatment.

Despite its benefits, tacrine poses safety concerns, particularly the risk of liver enzyme elevations and gastrointestinal side effects, although it has been found to be manageable in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The therapeutic potential of tacrine. Kurz, A.[2019]

In a study of 30 Alzheimer's patients, treatment with 1,000 mg/day of citicoline for 12 weeks significantly improved cognitive performance compared to placebo, especially in patients with mild dementia and those carrying the APOE E4 allele.

Citicoline was well tolerated with no adverse side effects, and it also increased cerebral blood flow and altered brain bioelectrical activity, suggesting it may be a beneficial treatment for Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-blind placebo-controlled study with citicoline in APOE genotyped Alzheimer's disease patients. Effects on cognitive performance, brain bioelectrical activity and cerebral perfusion. Alvarez, XA., Mouzo, R., Pichel, V., et al.[2013]

In a 30-week multicenter trial involving 415 patients with mild to moderate Alzheimer's disease, tacrine hydrochloride was found to significantly improve or stabilize cognitive and noncognitive symptoms compared to a placebo, particularly in areas like memory and mood.

The study suggests that tacrine's effects on specific cognitive and noncognitive deficits can be better evaluated by focusing on individual assessment items from the Alzheimer's Disease Assessment Scale (ADAS), enhancing the understanding of its therapeutic impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of tacrine on language, praxis, and noncognitive behavioral problems in Alzheimer disease. Raskind, MA., Sadowsky, CH., Sigmund, WR., et al.[2019]

In a study involving 1,920 patients with mild to moderate Alzheimer's disease, donepezil was found to be well tolerated, with a completion rate of 79% and a favorable safety profile at doses of 5 mg and 10 mg.

While 11% of patients on donepezil withdrew due to adverse events compared to 7% on placebo, the most common side effects were manageable and included nausea and dizziness, with no significant impact on laboratory tests or liver function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Donepezil: tolerability and safety in Alzheimer's disease. Pratt, RD., Perdomo, CA., Surick, IW., et al.[2022]

In a pilot study involving six Alzheimer's patients, intravenous nicotine at a dose of 0.25 microgram/kg/min improved cognitive performance by reducing errors in cognitive tests, suggesting potential benefits for cholinergic functioning in Alzheimer's disease.

However, the study also found that nicotine increased anxiety and depressive symptoms in a dose-dependent manner, indicating the need for careful consideration of side effects in future research on nicotine as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous nicotine in Alzheimer's disease: a pilot study. Newhouse, PA., Sunderland, T., Tariot, PN., et al.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9866349/

Is Citicoline Effective in Preventing and Slowing Down ...

Overall, citicoline improved cognitive status, with pooled standardized mean differences ranging from 0.56 (95% CI: 0.37–0.75) to 1.57 (95% CI: ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S002231662200267X

Citicoline and Memory Function in Healthy Older Adults

Dietary supplementation of citicoline for 12 wk improved overall memory performance, especially episodic memory, in healthy older males and females with AAMI.

3.

efsa.onlinelibrary.wiley.com

efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2024.8861

'Citicoline' and support of the memory function: Evaluation of a ...

Improvement, maintenance or reduced loss of memory is a beneficial physiological effect for middle-aged or elderly adults encountering age- ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38905051/

Citicoline: A Cholinergic Precursor with a Pivotal Role in ...

This study confirmed the effectiveness of combined citicoline treatment in patients with mixed dementia and Alzheimer's disease.

5.

jarlife.net

jarlife.net/1528-citicoline-efficiency-on-cognitive-function-a-systematic-review.html

CITICOLINE EFFICIENCY ON COGNITIVE FUNCTION

A positive effect of citicoline on MMSE in acute ischemic stroke was found, which was not evidenced for Alzheimer disease or vascular dementia.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11307077/

Citicoline: A Cholinergic Precursor with a Pivotal Role in ...

This study confirmed the effectiveness of combined citicoline treatment in patients with mixed dementia and Alzheimer's disease.

7.

alzdiscovery.org

alzdiscovery.org/uploads/cognitive_vitality_media/Citicoline_UPDATE_%28supplement%29.pdf

Citicoline (CDP-choline)

Citicoline is safe and very well-tolerated form of choline with good brain bioavailability, and may help protect against cognitive dysfunction related to ...