Improving Sleep and AD Biomarkers

NCT06029894 | Completed DMC

• 3 other identifiers: STUDY000060471R61AG080606-012025P010359
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Mild Cognitive Impairment; Alzheimer Disease

Keywords

Dementia; Citicoline supplement

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  Baseline and 3 months

• Change in plasma choline levels

  Blood draws will be made at baseline and follow-up.

  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.

  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.

  Baseline and 3 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

Participants with MCI will receive dietary citicoline supplements.

Dietary Supplement: Citicoline Supplement

Placebo

PLACEBO COMPARATOR

Participants with MCI will receive a placebo supplement.

Other: Placebo

Interventions

Placebo OTHER

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.

Placebo

Citicoline Supplement DIETARY_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. Participants will undergo a blood draw of approximately 20 ml at baseline and at follow-up.

Also known as: Citicoline 1000mg

Treatment Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Emory University School of Nursing

Atlanta, Georgia, 30322, United States

Location

Goizueta Alzheimer's Disease Research Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Dementia

Interventions

Cytidine Diphosphate Choline

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Victoria Pak, PhD, MS, MTR

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Citicoline and placebo treatment will be blinded. The study treatment will be labeled using a unique Kit ID number that is linked to a randomization scheme. The active and placebo tablets will be identical and presented in the same packaging to ensure the blinding of the study medication.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: September 8, 2023
• Study Start: December 15, 2023
• Primary Completion: December 21, 2025
• Study Completion: December 21, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Anticipated data availability will be at the conclusion of this study on 7/1/25.
• Access Criteria: Data will be shared with the Aging Research Biobank. The data generated in this study will be housed in the Aging Research Biobank. The database can be found at the following link: agingresearchbiobank.nia.nih.gov

Locations

US (2)