Clinical trial NCT06029894: Improving Sleep and AD Biomarkers
Official title: Improving Sleep and Alzheimer's Disease (AD) Biomarkers: A Pilot Randomized Clinical Trial (RCT) of Citicoline
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Alzheimer Disease
Keywords: Dementia
Citicoline supplement
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-09-08
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and 3 months
measure: Change in the Epworth Sleepiness Scale (ESS)
timeFrame: Baseline and 3 months
measure: Change in percentage of the rapid eye movement (REM) sleep
timeFrame: Baseline and 3 months
measure: Change in sleep duration
timeFrame: Baseline and 3 months
measure: Change in plasma choline levels
timeFrame: Baseline and 3 months
measure: Change in beta-amyloid 42 levels
timeFrame: Baseline and 3 months
measure: Change in tau and phospho-tau levels
timeFrame: Baseline and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Nursing
state: Georgia
city: Atlanta
country: United States
facility: Goizueta Alzheimer's Disease Research Center
state: Georgia
Study officials:
affiliation: Emory University
name: Victoria Pak, PhD, MS, MTR
role: PRINCIPAL_INVESTIGATOR
References: