Improving Sleep and AD Biomarkers

NCT ID: NCT06029894

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-15
• Study Completion Date: 2026-01-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment Group

Participants with MCI will receive dietary citicoline supplements.

Group Type: EXPERIMENTAL

Citicoline Supplement

Intervention Type: 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.

Placebo

Participants with MCI will receive a placebo supplement.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

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 undergo a blood draw of approximately 20 ml at baseline and at follow-up.

Intervention Type: OTHER

Other Intervention Names

Citicoline 1000mg

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Victoria Pak

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Victoria Pak, PhD, MS, MTR

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University School of Nursing

Atlanta, Georgia, United States

Goizueta Alzheimer's Disease Research Center

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R61AG080606-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00006047

Identifier Type: -

Identifier Source: org_study_id