Mild Cognitive ImpairmentNCT06029894
Improving Sleep and AD Biomarkers
A study testing Citicoline Supplement in people with Mild Cognitive Impairment and Alzheimer Disease, run by Emory University at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease
- What is being tested?
- Citicoline Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Dec 2023to 21 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 and contacts
2 sites in 1 country.
United States2 sites
Emory University School of Nursing
Atlanta, Georgia, 30322
Goizueta Alzheimer's Disease Research Center
Atlanta, Georgia, 30329
About this study
Official title: Improving Sleep and Alzheimer's Disease (AD) Biomarkers: A Pilot Randomized Clinical Trial (RCT) of Citicoline
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.
Read the detailed description
This is a randomized double-blind placebo-controlled pilot trial. To assess the hypothesis in this proposed study, the investigator will leverage infrastructure from the Emory Alzheimer's disease research center (ADRC), ADRC-affiliated centers, mild cognitive impairment, related research cohorts with potential eligible participants interested in participating in future studies, the Emory Sleep Center, and also recruit from the community. The research team will be actively recruiting individuals with MCI with confirmed medical diagnoses. The investigator will also collect data from personal interviews on prior medical diagnoses from the medical record along with current medication usage. Researchers will also obtain available baseline AD biomarker data from participants at baseline if they have cerebrospinal fluid (CSF) and/or blood data available on AD biomarkers within the past year from prior research studies, the investigators will use this data for the study records which will serve as their 'baseline' AD biomarker level). AD biomarkers of interest include Amyloid-Beta 1-42 (Aβ42), t-tau, and P-tau181. Should participants not have this data available at baseline, the research team will conduct a blood draw for AD biomarker levels at baseline and at follow-up.
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Being tested
- Citicoline Supplement, Placebo
- Keywords
- Dementia, Citicoline supplement
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citicoline SupplementDietary supplement
Also called Citicoline 1000mg
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. Participants will undergo a blood draw of approximately 20 ml at baseline and at follow-up.
PlaceboOther
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 undergo a blood draw of approximately 20 ml at baseline and at follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Participants with MCI will receive dietary citicoline supplements. Receives: Dietary Supplement: Citicoline Supplement |
| Placebo | Placebo comparator | Participants with MCI will receive a placebo supplement. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Pittsburgh Sleep Quality Index (PSQI)
This questionnaire is used to measure subjective sleep quality. It has strong validity and reliability in clinical populations and consists of 19 items asking about sleep disturbances over the past month with 7 dimensions. Each dimension scores 0 (no difficulty) to 3 (severe difficulty) and the sum of these scores yields a global sleep quality score that ranges from 0-21. Higher scores indicate greater difficulty sleeping. This questionnaire can be filled out by the participant, caregiver, or both as appropriate.
Measured: Baseline and 3 months
Change in the Epworth Sleepiness Scale (ESS)
The ESS is a clinical and research standard used to assess perceived daytime sleepiness over the past month. It is a self-administered validated questionnaire and takes 2-3 minutes to fill out. Respondents are asked to rate how likely they are to doze off in 8 situations, from 0 (would never dose) to 3 (high chance of dozing). Any score of 10 or above is considered an indicator of pathologic sleepiness. This questionnaire can be filled out by the participant, caregiver, or both as appropriate.
Measured: Baseline and 3 months
Change in percentage of the rapid eye movement (REM) sleep
The change in % REM sleep will be measured using The Sleep Profiler using the polysomnography 2 (PSG2), which is an Electroencephalogram (EEG) Sleep Monitor that is an FDA-cleared, easily applied, wireless EEG device developed and validated to measure sleep architecture for in-home sleep studies. This will be worn for 2 nights at baseline and again for 2 nights at follow-up.
Measured: Baseline and 3 months
Change in sleep duration
Average sleep duration (hours) will be measured via a subjective 7-day sleep diary that collects subjective sleep/wake patterns and naps. It is the "gold standard" for subjective sleep assessment of sleep duration. It will be filled out by the participant in conjunction with the caregiver.
Measured: Baseline and 3 months
Change in plasma choline levels
Blood draws will be made at baseline and follow-up.
Measured: Baseline and 3 months
Change in beta-amyloid 42 levels
Levels of beta-amyloid 42. A lumbar puncture (LP) will be performed at 3 months in participants who have already had a previous LP. For those who don't have a previous LP performed, blood samples will be drawn before starting the study medication and at follow-up.
Measured: Baseline and 3 months
Change in tau and phospho-tau levels
Levels of tau, and phospho-tau will be measured. A lumbar puncture (LP) will be performed at 3 months in participants who have already had a previous LP. For those who don't have a previous LP performed, blood samples will be drawn before starting the study medication and at follow-up.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start15 Dec 2023
- Primary completion21 Dec 2025
- Study completion21 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Victoria Pak, Emory University
- Investigators
- Victoria Pak, PhD, MS, MTR, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029894
- Sponsor's protocol ID
- STUDY00006047
- Other IDs
- 1R61AG080606-01, 2025P010359
- Status last verified
- Feb 2026
- First submitted
- 10 Aug 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team will share deidentified data in accordance with the NIH Data Sharing Policy to share research resources (biological samples and finalized data). Deidentified data and deidentified biological samples will be stored and shared with other institutions or companies as approved by a Scientific Review Committee and in accordance with all applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sleep and Alzheimer's Disease (AD) Biomarkers: A Pilot Randomized Clinical Trial (RCT) of Citicoline
- ClinicalTrials.gov ID
- NCT06029894
- Acronym / sponsor ID
- STUDY00006047
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Keywords
- Dementia, Citicoline supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 21 Dec 2025 (actual)
- Study completion
- 21 Dec 2025 (actual)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized double-blind placebo-controlled pilot trial. To assess the hypothesis in this proposed study, the investigator will leverage infrastructure from the Emory Alzheimer's disease research center (ADRC), ADRC-affiliated centers, mild cognitive impairment, related research cohorts with potential eligible participants interested in participating in future studies, the Emory Sleep Center, and also recruit from the community. The research team will be actively recruiting individuals with MCI with confirmed medical diagnoses. The investigator will also collect data from personal interviews on prior medical diagnoses from the medical record along with current medication usage. Researchers will also obtain available baseline AD biomarker data from participants at baseline if they have cerebrospinal fluid (CSF) and/or blood data available on AD biomarkers within the past year from prior research studies, the investigators will use this data for the study records which will serve as their 'baseline' AD biomarker level). AD biomarkers of interest include Amyloid-Beta 1-42 (Aβ42), t-tau, and P-tau181. Should participants not have this data available at baseline, the research team will conduct a blood draw for AD biomarker levels at baseline and at follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Dietary Supplement: Citicoline SupplementParticipants with MCI will receive dietary citicoline supplements. |
| Placebo | Placebo comparator | Other: PlaceboParticipants with MCI will receive a placebo supplement. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Citicoline SupplementAlso: Citicoline 1000mgParticipants 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. Participants will undergo a blood draw of approximately 20 ml at baseline and at follow-up. | Dietary supplement | Treatment Group |
| PlaceboParticipants 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 undergo a blood draw of approximately 20 ml at baseline and at follow-up. | Other | Placebo |
Primary outcome
Change in the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and 3 months
This questionnaire is used to measure subjective sleep quality. It has strong validity and reliability in clinical populations and consists of 19 items asking about sleep disturbances over the past month with 7 dimensions. Each dimension scores 0 (no difficulty) to 3 (severe difficulty) and the sum of these scores yields a global sleep quality score that ranges from 0-21. Higher scores indicate greater difficulty sleeping. This questionnaire can be filled out by the participant, caregiver, or both as appropriate.
Change in the Epworth Sleepiness Scale (ESS)
Time frame: Baseline and 3 months
The ESS is a clinical and research standard used to assess perceived daytime sleepiness over the past month. It is a self-administered validated questionnaire and takes 2-3 minutes to fill out. Respondents are asked to rate how likely they are to doze off in 8 situations, from 0 (would never dose) to 3 (high chance of dozing). Any score of 10 or above is considered an indicator of pathologic sleepiness. This questionnaire can be filled out by the participant, caregiver, or both as appropriate.
Change in percentage of the rapid eye movement (REM) sleep
Time frame: Baseline and 3 months
The change in % REM sleep will be measured using The Sleep Profiler using the polysomnography 2 (PSG2), which is an Electroencephalogram (EEG) Sleep Monitor that is an FDA-cleared, easily applied, wireless EEG device developed and validated to measure sleep architecture for in-home sleep studies. This will be worn for 2 nights at baseline and again for 2 nights at follow-up.
Change in sleep duration
Time frame: Baseline and 3 months
Average sleep duration (hours) will be measured via a subjective 7-day sleep diary that collects subjective sleep/wake patterns and naps. It is the "gold standard" for subjective sleep assessment of sleep duration. It will be filled out by the participant in conjunction with the caregiver.
Change in plasma choline levels
Time frame: Baseline and 3 months
Blood draws will be made at baseline and follow-up.
Change in beta-amyloid 42 levels
Time frame: Baseline and 3 months
Levels of beta-amyloid 42. A lumbar puncture (LP) will be performed at 3 months in participants who have already had a previous LP. For those who don't have a previous LP performed, blood samples will be drawn before starting the study medication and at follow-up.
Change in tau and phospho-tau levels
Time frame: Baseline and 3 months
Levels of tau, and phospho-tau will be measured. A lumbar puncture (LP) will be performed at 3 months in participants who have already had a previous LP. For those who don't have a previous LP performed, blood samples will be drawn before starting the study medication and at follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes. The research team will share deidentified data in accordance with the NIH Data Sharing Policy to share research resources (biological samples and finalized data). Deidentified data and deidentified biological samples will be stored and shared with other institutions or companies as approved by a Scientific Review Committee and in accordance with all applicable regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Pak, PhD, MS, MTR principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citicoline Supplement in people with Mild Cognitive Impairment and Alzheimer Disease, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Pittsburgh Sleep Quality Index (PSQI) (time frame: Baseline and 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.