Improving Sleep and Alzheimer's Disease (AD) Biomarkers: A Pilot Randomized Clinical Trial (RCT) of Citicoline
Pilot study tests citicoline for sleep and Alzheimer's biomarkers in MCI
Plain English Summary
Improving Sleep and AD Biomarkers is a Not Applicable clinical trial sponsored by Emory University studying Mild Cognitive Impairment, Alzheimer Disease. This study tests if a dietary supplement called citicoline can improve sleep and cognitive function in people with Mild Cognitive Impairment (MCI). It is for individuals aged 60 and older who have been diagnosed with MCI and experience sleep disturbances. Participants will take either citicoline or a placebo for 3 months and undergo sleep and cognitive assessments. Alternatives for managing MCI and sleep issues include lifestyle changes, cognitive therapies, and other prescribed medications, depending on individual needs. The trial aims to enroll 100 participants.
Official 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 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 60 or older and have been diagnosed with Mild Cognitive Impairment (MCI). You must have issues with sleep quality or daytime sleepiness, be able to read and understand English, and have internet and email access. You cannot join if you have certain medical conditions like severe heart failure, diabetes, or sleep apnea, or if you are taking medications that affect sleep. This trial is studying Mild Cognitive Impairment, Alzheimer Disease, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes measure changes in sleep quality, daytime sleepiness, and specific sleep patterns, indicating how well the supplement might help participants sleep better. The specific primary outcome measures are: Change in the Pittsburgh Sleep Quality Index (PSQI) (Baseline and 3 months); Change in the Epworth Sleepiness Scale (ESS) (Baseline and 3 months); Change in percentage of the rapid eye movement (REM) sleep (Baseline and 3 months); Change in sleep duration (Baseline and 3 months); Change in plasma choline levels (Baseline and 3 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it explores a potential dietary supplement to improve sleep and cognitive health in individuals with Mild Cognitive Impairment, addressing a gap in non-pharmacological This research targets Mild Cognitive Impairment, Alzheimer Disease, where improved treatment options are needed.
Investor Insight
This pilot study signals interest in non-pharmacological interventions for MCI, a growing market driven by an aging population, with potential for citicoline as a well-tolerated supplement.
Is This Trial Right for Me?
Ask your doctor if citicoline is appropriate for you, considering your health history and current medications. Participation involves taking a supplement daily for 3 months and attending regular assessments for sleep and cognitive function. You will need to track your sleep and complete questionnaires about your sleep quality and cognitive abilities. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: DOUBLE
- Enrollment: 100 participants
Interventions
- DIETARY_SUPPLEMENT: Citicoline Supplement — Participants with MCI will receive dietary citicoline supplements. Subjective sleep measures will be measured via the Pittsburgh Sleep Quality Index (for measurement of sleep quality) and Epworth Sleepiness Scale (for measurement of sleepiness). Cognition will be measured by Rey Auditory Verbal Learning Test (RAVLT), Trail Making Test (TMT) Parts A \& B, and the Montreal Cognitive Assessment (MOCA). Participants will complete all questionnaires at baseline and at follow-up at 3 months. Participa
- OTHER: Placebo — Participants with MCI will receive a placebo supplement. Subjective sleep measures will be measured via the Pittsburgh Sleep Quality Index (for measurement of sleep quality) and Epworth Sleepiness Scale (for measurement of sleepiness). Cognition will be measured by Rey Auditory Verbal Learning Test (RAVLT), Trail Making Test (TMT) Parts A \& B, and the Montreal Cognitive Assessment (MOCA). Participants will complete all questionnaires at baseline and at follow-up at 3 months. Participants will u
Primary Outcomes
- Change in the Pittsburgh Sleep Quality Index (PSQI) (Baseline and 3 months)
- Change in the Epworth Sleepiness Scale (ESS) (Baseline and 3 months)
- Change in percentage of the rapid eye movement (REM) sleep (Baseline and 3 months)
- Change in sleep duration (Baseline and 3 months)
- Change in plasma choline levels (Baseline and 3 months)
Full Eligibility Criteria
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
Trial Locations
- Emory University School of Nursing, Atlanta, Georgia, United States
- Goizueta Alzheimer's Disease Research Center, Atlanta, Georgia, United States
Frequently Asked Questions
What is clinical trial NCT06029894?
NCT06029894 is a Not Applicable INTERVENTIONAL study titled "Improving Sleep and AD Biomarkers." It is currently completed and is sponsored by Emory University. The trial targets enrollment of 100 participants.
What conditions does NCT06029894 study?
This trial investigates treatments for Mild Cognitive Impairment, Alzheimer Disease. The primary condition under study is Mild Cognitive Impairment.
What treatments are being tested in NCT06029894?
The interventions being studied include: Citicoline Supplement (DIETARY_SUPPLEMENT), Placebo (OTHER). Participants with MCI will receive dietary citicoline supplements. Subjective sleep measures will be measured via the Pittsburgh Sleep Quality Index (for measurement of sleep quality) and Epworth Sleepiness Scale (for measurement of sleepiness). Cognition will be measured by Rey Auditory Verbal Learning Test (RAVLT), Trail Making Test (TMT) Parts A \& B, and the Montreal Cognitive Assessment (MOCA). Participants will complete all questionnaires at baseline and at follow-up at 3 months. Participa
What does Not Applicable mean for NCT06029894?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06029894?
This trial is currently "Completed." It started on 2023-12-15. The estimated completion date is 2025-12-21.
Who is sponsoring NCT06029894?
NCT06029894 is sponsored by Emory University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06029894?
The trial aims to enroll 100 participants. The trial status is completed.
How is NCT06029894 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT06029894?
The primary outcome measures are: Change in the Pittsburgh Sleep Quality Index (PSQI) (Baseline and 3 months); Change in the Epworth Sleepiness Scale (ESS) (Baseline and 3 months); Change in percentage of the rapid eye movement (REM) sleep (Baseline and 3 months); Change in sleep duration (Baseline and 3 months); Change in plasma choline levels (Baseline and 3 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06029894 being conducted?
This trial is being conducted at 2 sites, including Atlanta, Georgia (United States).
Where can I find official information about NCT06029894?
The official record for NCT06029894 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06029894. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06029894 testing in simple terms?
This study tests if a dietary supplement called citicoline can improve sleep and cognitive function in people with Mild Cognitive Impairment (MCI). It is for individuals aged 60 and older who have been diagnosed with MCI and experience sleep disturbances.
Why is this trial significant?
This trial is important because it explores a potential dietary supplement to improve sleep and cognitive health in individuals with Mild Cognitive Impairment, addressing a gap in non-pharmacological
What are the potential risks of participating in NCT06029894?
The main risks are potential allergic reactions to citicoline components. Some participants might experience side effects related to sleep disturbances or cognitive changes, though citicoline has been found to be well-tolerated in similar populations. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06029894?
Ask your doctor if citicoline is appropriate for you, considering your health history and current medications. Participation involves taking a supplement daily for 3 months and attending regular assessments for sleep and cognitive function. You will need to track your sleep and complete questionnaires about your sleep quality and cognitive abilities. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06029894 signal from an investment perspective?
This pilot study signals interest in non-pharmacological interventions for MCI, a growing market driven by an aging population, with potential for citicoline as a well-tolerated supplement. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will take either citicoline or a placebo for 3 months and undergo sleep and cognitive assessments. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.