20 Participants Needed

Citicoline Supplement for Alzheimer's Disease

Recruiting at 1 trial location
VP
Overseen ByVictoria Pak, PhD, MS, MTR
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Emory University

Trial Summary

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.

What data supports the effectiveness of the drug Citicoline supplement for Alzheimer's disease?

Research shows that Citicoline, a substance involved in brain health, improved cognitive performance in Alzheimer's patients compared to a placebo, especially in those with a specific genetic marker (APOE E4).12345

Is citicoline safe for humans?

Citicoline has been used extensively for various neurodegenerative disorders, including Alzheimer's disease, and is generally considered safe in humans. In a study with Alzheimer's patients, no significant safety concerns were reported during a 12-week treatment with citicoline compared to a placebo.16789

How does the drug citicoline differ from other Alzheimer's treatments?

Citicoline is unique because it is an endogenous compound that helps in the production of brain phospholipids and acetylcholine, which are important for brain function. Unlike other Alzheimer's treatments that focus on inhibiting the breakdown of acetylcholine, citicoline supports the synthesis of these essential components, potentially improving cognitive performance.1381011

What is the purpose of this trial?

This trial is testing whether a citicoline supplement can help people with Alzheimer's Disease sleep better and think more clearly. Citicoline may boost brain chemicals that are important for memory and sleep. Citicoline has been extensively used for the treatment of neurodegenerative disorders associated with head trauma, stroke, brain aging, cerebrovascular pathology, and Alzheimer's disease.

Research Team

VP

Victoria Pak, PhD, MS, MTR

Principal Investigator

Emory School of Nursing, School of Public Health

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Citicoline SupplementExperimental Treatment1 Intervention
Participants with AD will receive a dietary citicoline supplement
Group II: PlaceboPlacebo Group1 Intervention
Participants with AD will receive a placebo supplement

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

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+

Findings from Research

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

References

Double-blind placebo-controlled study with citicoline in APOE genotyped Alzheimer's disease patients. Effects on cognitive performance, brain bioelectrical activity and cerebral perfusion. [2013]
Effect of tacrine on language, praxis, and noncognitive behavioral problems in Alzheimer disease. [2019]
Physostigmine and tetrahydroaminoacridine treatment of Alzheimer's disease. [2019]
An evaluation of the efficacy and safety of tetrahydroaminoacridine (THA) without lecithin in the treatment of Alzheimer's disease. [2019]
Predictors of sustained response to rivastigmine in patients with Alzheimer's disease: a retrospective analysis. [2021]
Treatment of cognitive impairment in Alzheimer's disease. [2021]
The therapeutic potential of tacrine. [2019]
Intravenous nicotine in Alzheimer's disease: a pilot study. [2019]
Donepezil: tolerability and safety in Alzheimer's disease. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Pharmacologic approaches to cognitive deficits in Alzheimer's disease. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Long-term administration of oral physostigmine in Alzheimer's disease. [2019]
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