Improving Sleep and AD Biomarkers
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 impairment. The investigators are studying persons with mild cognitive impairment (MCI). For this population, the team will assess whether citicoline also impacts biomarkers, a marker of the patient's biological state, in their body. The investigators are interested in learning more about a dietary supplement called citicoline and how it helps sleep, cognition, and markers of Alzheimer's. Previous studies have evaluated this dietary supplement and shown that citicoline may impact cognitive decline. The investigator would like to evaluate if citicoline will also impact sleep and markers of Alzheimer's. This dietary supplement has been assessed in older adults and found to be well tolerated. Citicoline has been used safely in cognitive impairment populations at the same dosage.
Conditions:
🦠 Mild Cognitive Impairment 🦠 Alzheimer Disease
🗓️ Study Start (Actual) 15 December 2023
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) December 2024
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Atlanta, Georgia, United States
📍 Atlanta, Georgia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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 Criteria:

    • * 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
Ages Eligible for Study: 60 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 August 2023
  • First Submitted that Met QC Criteria 1 September 2023
  • First Posted 8 September 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 11 January 2024
  • Last Update Posted 16 January 2024
  • Last Verified January 2024