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Citicoline Supplement for Mild Cognitive Impairment

N/A
Recruiting
Led By Victoria Pak, PhD, MS, MTR
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: 60 years or older
Diagnosis of Mild Cognitive Impairment (MCI)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3 months
Awards & highlights

Study Summary

This trial will assess if a dietary citicoline supplement impacts sleep and cognition in people with mild cognitive impairment (MCI). It will also evaluate biomarkers that may help predict Alzheimer's.

Who is the study for?
This trial is for people aged 60 or older with Mild Cognitive Impairment (MCI) who have trouble sleeping, as shown by specific sleep quality scores. Participants must speak English and have internet access. It's not for those on certain medications, using choline supplements, with a history of severe head trauma or epilepsy, allergies to Citicoline ingredients, serious health conditions like heart failure or diabetes, psychiatric disorders, sleep apnea, restless legs syndrome or irregular work schedules.Check my eligibility
What is being tested?
The study tests if a dietary supplement called citicoline can improve sleep and cognitive function in individuals with MCI. Researchers will also check if it affects Alzheimer's biomarkers in the body. Participants will either receive the citicoline supplement or a placebo without knowing which one they are taking.See study design
What are the potential side effects?
Citicoline is generally well-tolerated in older adults and has been used safely at similar doses in people with cognitive impairments. However, potential side effects were not explicitly listed; typically such supplements may cause digestive discomfort or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 60 years old or older.
Select...
I have been diagnosed with Mild Cognitive Impairment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 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
Change in beta-amyloid 42 levels
Change in percentage of the rapid eye movement (REM) sleep
Change in plasma choline levels
+4 more

Side effects data

From 2016 Phase 4 trial • 62 Patients • NCT02074735
17%
Drowsiness
14%
Dry mouth
14%
Nausea
10%
Diarrhea
7%
Headache
3%
Bruising
3%
Increased energy
3%
Hypertension
3%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Citicoline
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment GroupExperimental Treatment1 Intervention
Participants with MCI will receive dietary citicoline supplements.
Group II: PlaceboPlacebo Group1 Intervention
Participants with MCI will receive a placebo supplement.

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,596 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,785 Total Patients Enrolled
Victoria Pak, PhD, MS, MTRPrincipal InvestigatorEmory University
1 Previous Clinical Trials
20 Total Patients Enrolled

Frequently Asked Questions

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

Are there still openings in this ongoing clinical trial?

"According to clinicaltrials.gov, the trial is no longer recruiting new patients as it was posted on October 1st 2020 and last updated on September 1st 2023. Despite this, 1043 other studies are still seeking research participants at present."

Answered by AI

Who else is applying?

What site did they apply to?
Goizueta Alzheimer's Disease Research Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Improving Sleep and AD Biomarkers
Victoria Pak 2023. "Improving Sleep and AD Biomarkers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06029894.
~64 spots leftby Dec 2024
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