Citicoline Supplement for Alzheimer's Disease

No longer recruiting at 1 trial location
VP
Overseen ByVictoria Pak, PhD, MS, MTR
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Emory University

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.12345

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.24567

Who Is on the Research Team?

VP

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)
See 1 more

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.
See 2 more

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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Citicoline SupplementExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

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

Citations

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: ...
Citicoline and Memory Function in Healthy Older AdultsDietary supplementation of citicoline for 12 wk improved overall memory performance, especially episodic memory, in healthy older males and females with AAMI.
'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.govpubmed.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.
CITICOLINE EFFICIENCY ON COGNITIVE FUNCTIONA positive effect of citicoline on MMSE in acute ischemic stroke was found, which was not evidenced for Alzheimer disease or vascular dementia.
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.
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 ...
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