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| ID | Type | Description | Link |
|---|---|---|---|
| P50AG025688 | U.S. NIH Grant/Contract | View source | |
| 2025P010359 | Other Identifier | Emory IRB |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Emory Goizueta Alzheimer's Disease Research Center (ADRC) | UNKNOWN |
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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.
The research team will test these hypotheses via a randomized, double-blind, placebo-controlled pilot study of citicoline in individuals with AD. Participants will be recruited from the Alzheimer's Disease Research Center (ADRC) and from the community in the surrounding Atlanta area. This will be a 3-month randomized, double-blind, placebo-controlled trial comparing citicoline and placebo in a well-characterized cohort of 20 individuals with AD. 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). For neuropsychological and cognition will be measured measures, the research team will employ the Rey Auditory Verbal Learning Test (RAVLT), Trail Making Test (TMT) Parts A & B, and the Montreal Cognitive Assessment (MOCA).
Those participating in the ADRC parent study or recruited from the community and diagnosed with AD in their medical record and aged 18 and over are eligible to participate. Eligible participants will be enrolled in a two-treatment trial comparing the effects of citicoline (1000 mg once per day with or without food) to a placebo. There will be a baseline (T0) visit and a follow-up 3 months later (T1) as a separate visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Citicoline Supplement | Experimental | Participants with AD will receive a dietary citicoline supplement |
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| Placebo | Placebo Comparator | Participants with AD will receive a placebo supplement |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) | To examine how a change in sleep correlates with changes in cognitive function following the administration of citicoline, an assessment of cognitive function will be performed using the Montreal Cognitive Assessment (MoCA). The MoCA assesses global cognitive function and is a rapid screening instrument that takes approximately 10 minutes. It assesses various cognitive domains, including attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. This questionnaire will be administered to the participant through the ADRC at their baseline visit, and the researchers will measure it separately at their follow-up visit at 3 months. The total is out of 30 points. Scores below 26 can suggest varying degrees of cognitive impairment. For example, scores between 18 and 25 may indicate mild impairment, while scores between 10 and 17 might suggest moderate impairment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victoria Pak, PhD, MS, MTR | Emory School of Nursing, School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University School of Nursing | Atlanta | Georgia | 30322 | United States | ||
| Goizueta Alzheimer's Disease Research Center |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 30, 2024 | Sep 12, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. |
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| Baseline and 3 months |
| Rey Auditory Verbal Learning Test (RAVLT) | To examine how a change in sleep correlates with changes in memory function with the administration of citicoline,the research team will use the Rey Auditory Verbal Learning Test (RAVLT): RAVLT evaluates the nature and severity of memory dysfunction and is used to track changes in memory function in patients over time. It is designed to present a list of 15 words across five consecutive trials. The list is first read aloud to the participant, and the participant is immediately asked to recall as many words as possible. | Baseline and 3 months |
| Trail Making Test (TMT) | To examine how a change in sleep correlates with changes in executive functioning with the administration of citicoline, participants will complete the Trail Making Test (TMT) Parts A & B: TMT assesses executive functioning. The test consists of two parts-Part A and Part B. In Part A, participants are asked to draw lines sequentially connecting 25 numbers distributed on paper. In Part B, in contrast, participants are asked to draw lines sequentially, while alternating between numbers and letters. The time spent to complete the task will be recorded for evaluation. | Baseline and 3 months |
| Atlanta |
| Georgia |
| 30329 |
| United States |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D012893 | Sleep Wake Disorders |