Status:
ACTIVE_NOT_RECRUITING
Improving Sleep and AD Biomarkers
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Mild Cognitive Impairment
Alzheimer Disease
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
The purpose of this research is to learn whether a dietary citicoline supplement will impact sleep and cognition. Cognitive disorders include such things as memory disorders and mild cognitive impairm...
Detailed Description
This is a randomized double-blind placebo-controlled pilot trial. To assess the hypothesis in this proposed study, the investigator will leverage infrastructure from the Emory Alzheimer's disease rese...
Eligibility Criteria
Inclusion
- Age: 60 years or older
- Diagnosis of Mild Cognitive Impairment (MCI)
- Pittsburgh Sleep Quality Index total score \>5 or Epworth Sleepiness Scale score of ≥ 10
- Read and understand English
- Have Internet and email access
Exclusion
- No telephone access
- Must not be taking any medication known to affect rapid eye movement (REM) sleep (or sleep architecture in general)
- Use of choline supplements.
- Epilepsy or head trauma resulting in unconsciousness in the past two years
- Known allergic reactions to components of Citicoline
- Presence of chronic obstructive pulmonary disease, asthma, severe cardiac insufficiency (congestive heart failure, myocardial infarction), type I diabetes, vitamin B12 or folic acid deficiency, liver cirrhosis, thyroid dysfunction, rheumatoid arthritis, chronic renal failure, severe/unstable psychiatric disorders, moderate to severe obstructive sleep apnea, restless legs syndrome or periodic limb movement disorder
- History of alcohol dependence and drug abuse
- Night shift workers or those in situations where they regularly experience jet lag or have irregular work schedules
Key Trial Info
Start Date :
December 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06029894
Start Date
December 15 2023
End Date
January 1 2026
Last Update
September 26 2025
Active Locations (2)
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1
Emory University School of Nursing
Atlanta, Georgia, United States, 30322
2
Goizueta Alzheimer's Disease Research Center
Atlanta, Georgia, United States, 30329