Back to resultsImproving Sleep and Cognition in Alzheimer's Disease
Primary Purpose
Alzheimer Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Citicoline supplement
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Sleep disturbance
Eligibility Criteria
Inclusion Criteria:
- Participants diagnosed with AD and confirmed from the medical record.
- At least 18 years of age living within the continental United States
- Patients treated with donepezil, the dose level must be stable for at least 3 months prior to screening.
- Read and understand English
- Have Internet and email access (this criterion applies to the legally authorized representatives)
- Agree to be contacted for future studies (during screening, participants are asked if they are interested in being contacted for future studies)
Exclusion Criteria:
- Legally authorized representative unable or unwilling to provide informed consent
- No telephone access
- Treated with other medications used for AD (ex. memantine) or other cholinergic precursors (ex. choline alphoscerate, choline bitartrate, L-α-glycerophosphorylethanolamine) or other nootropics (ex. homotaurine)
- 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
Sites / Locations
- Emory University School of NursingRecruiting
- Goizueta Alzheimer's Disease Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Citicoline Supplement
Placebo
Arm Description
Participants with AD will receive a dietary citicoline supplement
Participants with AD will receive a placebo supplement
Outcomes
Primary Outcome Measures
Change in the impact on sleep by the administration of the citicoline supplement.
Assessment will be performed 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.
Change in the impact on daytime sleepiness by the administration of the citicoline supplement.
Assessment will be performed by completing 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 approximately 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.
Secondary Outcome Measures
To examine how a change in sleep correlates with changes in cognitive function with the administration of citicoline.
Assessment of the cognitive function will be performed using the Montreal Cognitive Assessment (MoCA): MoCA assesses global cognitive function and is a rapid screening instrument that takes approximately 10 minutes. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. This questionnaire will already be administered through the ADRC to the participant at their baseline visit, the researchers will measure separately at their follow-up visit at 3 months.
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.
To examine how a change in sleep correlates with changes in executive functioning with the administration of citicoline.
Assessment will be performed using 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.
Full Information
NCT ID
NCT05200208
First Posted
January 18, 2022
Last Updated
July 23, 2023
Sponsor
Emory University
Collaborators
National Institute on Aging (NIA), Goizueta Alzheimer's Disease Research Center (ADRC)
1. Study Identification
Unique Protocol Identification Number
NCT05200208
Brief Title
Improving Sleep and Cognition in Alzheimer's Disease
Official Title
Improving Sleep and Cognition in Alzheimer's Disease: A Pilot RCT of Citicoline
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute on Aging (NIA), Goizueta Alzheimer's Disease Research Center (ADRC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Sleep disturbance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Citicoline Supplement
Arm Type
Experimental
Arm Description
Participants with AD will receive a dietary citicoline supplement
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants with AD will receive a placebo supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Citicoline supplement
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the impact on sleep by the administration of the citicoline supplement.
Description
Assessment will be performed 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.
Time Frame
Baseline and 3 months
Title
Change in the impact on daytime sleepiness by the administration of the citicoline supplement.
Description
Assessment will be performed by completing 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 approximately 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.
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
To examine how a change in sleep correlates with changes in cognitive function with the administration of citicoline.
Description
Assessment of the cognitive function will be performed using the Montreal Cognitive Assessment (MoCA): MoCA assesses global cognitive function and is a rapid screening instrument that takes approximately 10 minutes. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. This questionnaire will already be administered through the ADRC to the participant at their baseline visit, the researchers will measure separately at their follow-up visit at 3 months.
Time Frame
Baseline and 3 months
Title
To examine how a change in sleep correlates with changes in memory function with the administration of citicoline.
Description
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.
Time Frame
Baseline and 3 months
Title
To examine how a change in sleep correlates with changes in executive functioning with the administration of citicoline.
Description
Assessment will be performed using 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.
Time Frame
Baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Pak, PhD, MS, MTR
Phone
470-296-0081
Email
victoria.m.pak@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Pak, PhD, MS, MTR
Organizational Affiliation
Emory School of Nursing, School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University School of Nursing
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
Goizueta Alzheimer's Disease Research Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Improving Sleep and Cognition in Alzheimer's Disease
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