ACTIVE_NOT_RECRUITING

Improving Sleep and AD Biomarkers

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Improving Sleep and Alzheimer's Disease (AD) Biomarkers: A Pilot Randomized Clinical Trial (RCT) of Citicoline

Quick Facts

Study Start:2023-12-15
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06029894

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: 60 years or older
  2. * Diagnosis of Mild Cognitive Impairment (MCI)
  3. * Pittsburgh Sleep Quality Index total score \>5 or Epworth Sleepiness Scale score of ≥ 10
  4. * Read and understand English
  5. * Have Internet and email access
  1. * No telephone access
  2. * Must not be taking any medication known to affect rapid eye movement (REM) sleep (or sleep architecture in general)
  3. * Use of choline supplements.
  4. * Epilepsy or head trauma resulting in unconsciousness in the past two years
  5. * Known allergic reactions to components of Citicoline
  6. * 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
  7. * History of alcohol dependence and drug abuse
  8. * Night shift workers or those in situations where they regularly experience jet lag or have irregular work schedules

Contacts and Locations

Principal Investigator

Victoria Pak, PhD, MS, MTR
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Emory University School of Nursing
Atlanta, Georgia, 30322
United States
Goizueta Alzheimer's Disease Research Center
Atlanta, Georgia, 30329
United States

Collaborators and Investigators

Sponsor: Emory University

  • Victoria Pak, PhD, MS, MTR, PRINCIPAL_INVESTIGATOR, Emory University

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

Study Start Date2023-12-15
Study Completion Date2026-01

Study Record Updates

Study Start Date2023-12-15
Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

  • Dementia
  • Citicoline supplement

Additional Relevant MeSH Terms

  • Mild Cognitive Impairment
  • Alzheimer Disease