COMPLETED

Improving Sleep and Cognition in Alzheimer's Disease

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

Cognitive disorders include such things as memory disorders, mild cognitive impairment, and Alzheimer's disease (AD). The purpose of the study is to learn more about whether a dietary citicoline supplement will improve sleep and cognition. Sleep disturbances currently afflict approximately 25-44% of those with AD, resulting in decreased quality of life for those with AD and their caregivers and are a major driver of institutionalization. Previous studies have tested this dietary supplement in Alzheimer's disease and shown that citicoline may improve cognitive decline. The research team would like to see if citicoline will also improve sleep. The citicoline that will be provided is made by Kyowa Hakko Pharma Chemical Company. This dietary supplement has been tested for Alzheimer's disease and found to be well tolerated. Citicoline has previously been used safely in other Alzheimer's disease populations at the same dosage.

Official Title

Improving Sleep and Cognition in Alzheimer's Disease: A Pilot RCT of Citicoline

Quick Facts

Study Start:2022-07-27
Study Completion:2025-09-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05200208

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants who are diagnosed with AD and confirmed from the medical record.
  2. * At least 18 years of age living within the continental United States
  3. * Read and understand English
  4. * Have Internet and email access (this criterion applies to the legally authorized representatives)
  1. * No telephone access
  2. * Epilepsy or head trauma resulting in unconsciousness in the past two years
  3. * 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, and/or psychiatric disorders, obstructive sleep apnea, restless legs syndrome or periodic limb movement disorder
  4. * History of alcohol dependence and medication abuse
  5. * Night shift workers or those in situations where they regularly experience jet lag, or have irregular work schedules, since circadian misalignment may alter markers of inflammation

Contacts and Locations

Principal Investigator

Victoria Pak, PhD, MS, MTR
PRINCIPAL_INVESTIGATOR
Emory School of Nursing, School of Public Health

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 School of Nursing, School of Public Health

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 Date2022-07-27
Study Completion Date2025-09-21

Study Record Updates

Study Start Date2022-07-27
Study Completion Date2025-09-21

Terms related to this study

Keywords Provided by Researchers

  • Sleep disturbance

Additional Relevant MeSH Terms

  • Alzheimer Disease