Improving sleep and cognition in Alzheimer's disease patients
Improving Sleep and Cognition in Alzheimer's Disease: A Pilot RCT of Citicoline
NA · Emory University · NCT05200208
This study is testing if a dietary supplement called citicoline can improve sleep and thinking skills in people with Alzheimer's disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University (other) |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT05200208 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of a dietary citicoline supplement on sleep quality and cognitive function in individuals diagnosed with Alzheimer's disease. It will be conducted as a randomized, double-blind, placebo-controlled pilot trial involving 20 participants over a 3-month period. Participants will be assessed using various cognitive and sleep quality measures, including the Pittsburgh Sleep Quality Index and the Montreal Cognitive Assessment. The study seeks to determine if citicoline can alleviate sleep disturbances commonly experienced by Alzheimer's patients.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 and over diagnosed with Alzheimer's disease and living within the continental United States.
Not a fit: Patients with certain chronic conditions, psychiatric disorders, or those who have irregular work schedules may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life for Alzheimer's patients by improving their sleep and cognitive function.
How similar studies have performed: Previous studies have shown that citicoline may improve cognitive decline in Alzheimer's patients, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants who are diagnosed with AD and confirmed from the medical record. * At least 18 years of age living within the continental United States * Read and understand English * Have Internet and email access (this criterion applies to the legally authorized representatives) Exclusion Criteria: * No telephone access * Epilepsy or head trauma resulting in unconsciousness in the past two years * 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 * History of alcohol dependence and medication abuse * 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
Where this trial is running
Atlanta, Georgia and 1 other locations
- Emory University School of Nursing — Atlanta, Georgia, United States (RECRUITING)
- Goizueta Alzheimer's Disease Research Center — Atlanta, Georgia, United States (RECRUITING)
Study contacts
- Principal investigator: Victoria Pak, PhD, MS, MTR — Emory School of Nursing, School of Public Health
- Study coordinator: Victoria Pak, PhD, MS, MTR
- Email: victoria.m.pak@emory.edu
- Phone: 470-296-0081
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alzheimer Disease, Sleep disturbance