Improving Sleep and Cognition in Alzheimer's Disease

NCT05200208 | Completed

• 3 other identifiers: STUDY00002909P50AG0256882025P010359
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Cognitive disorders include such things as memory disorders, mild cognitive impairment, and Alzheimer's disease (AD). The purpose of the study is to learn more about whether a dietary citicoline supplement will improve sleep and cognition. Sleep disturbances currently afflict approximately 25-44% of those with AD, resulting in decreased quality of life for those with AD and their caregivers and are a major driver of institutionalization. Previous studies have tested this dietary supplement in Alzheimer's disease and shown that citicoline may improve cognitive decline. The research team would like to see if citicoline will also improve sleep. The citicoline that will be provided is made by Kyowa Hakko Pharma Chemical Company. This dietary supplement has been tested for Alzheimer's disease and found to be well tolerated. Citicoline has previously been used safely in other Alzheimer's disease populations at the same dosage.

Conditions

Alzheimer Disease

Keywords

Sleep disturbance

Outcome Measures

Primary Outcomes (2)

• Pittsburgh Sleep Quality Index (PSQI)

  Impact on sleep by the administration of the citicoline supplement will be assessed by completing 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

• Epworth Sleepiness Scale (ESS) Change in the impact on daytime sleepiness by the administration of the citicoline supplement.

  The impact on daytime sleepiness will be assessed by completing the Epworth Sleepiness Scale (ESS). The ESS is a clinical and research standard used to determine perceived daytime sleepiness over the past month. It is a self-administered, validated questionnaire and takes approximately 2-3 minutes to complete. Respondents are asked to rate how likely they are to doze off in 8 situations, from 0 (would never doze) to 3 (high chance of dozing). Any score of 10 or above is considered an indicator of pathologic sleepiness. This questionnaire can be completed by the participant, caregiver, or both as appropriate.

  Baseline and 3 months

Secondary Outcomes (3)

• Montreal Cognitive Assessment (MoCA)

  Baseline and 3 months

• Rey Auditory Verbal Learning Test (RAVLT)

  Baseline and 3 months

• Trail Making Test (TMT)

  Baseline and 3 months

Study Arms (2)

Citicoline Supplement

EXPERIMENTAL

Participants with AD will receive a dietary citicoline supplement

Dietary Supplement: Citicoline supplement

Placebo

PLACEBO COMPARATOR

Participants with AD will receive a placebo supplement

Other: Placebo

Interventions

Citicoline supplement DIETARY_SUPPLEMENT

Participants with AD will receive a dietary citicoline 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.

Citicoline Supplement

Placebo OTHER

Participants with AD 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.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute on Aging (NIA): collaborator
• Emory Goizueta Alzheimer's Disease Research Center (ADRC): 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

Alzheimer Disease; Parasomnias

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Sleep Wake Disorders

Study Officials

• Victoria Pak, PhD, MS, MTR

  Emory School of Nursing, School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 20, 2022
• Study Start: July 27, 2022
• Primary Completion: September 21, 2025
• Study Completion: September 21, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)