Clinical Trials Logo

Clinical Trial 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 in 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. Citicoline will be added to the standard of care treatment with donepezil.


Clinical Trial Description

The research team will test these hypotheses via a randomized, double-blind, placebo-controlled pilot study of citicoline in individuals with AD who are currently treated with donepezil. Participants will be recruited from the Alzheimer's Disease Research Center (ADRC) and from the community in the surrounding Atlanta area. Recruitment will be limited to those who have been prescribed donepezil as part of their clinical care. This will be a 3-month randomized, double-blind, placebo-controlled trial comparing citicoline+donepezil and placebo+donepezil 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 on donepezil at the maximum tolerated dosage (dose must be considered stable 3 months before screening confirmed by their physician) and aged 18 and over are eligible to participate. Eligible participants will be enrolled in a two-treatment trial comparing the effects of the standard of care donepezil and citicoline (1000 mg once per day with or without food) to the standard of care donepezil and placebo. The baseline (T0) visit will occur at the participant's annual ADRC visit and follow-up will occur 3 months later (T1) as a separate visit. For participants recruited from the community, the coordinator will arrange for an appropriate time for their baseline visit. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05200208
Study type Interventional
Source Emory University
Contact Victoria Pak, PhD, MS, MTR
Phone 470-296-0081
Email [email protected]
Status Recruiting
Phase N/A
Start date April 2022
Completion date June 2023

See also
  Status Clinical Trial Phase
Completed NCT04044495 - Sleep, Rhythms and Risk of Alzheimer's Disease N/A
Completed NCT04079803 - PTI-125 for Mild-to-moderate Alzheimer's Disease Patients Phase 2
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT04520698 - Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease N/A
Terminated NCT03672474 - REGEnLIFE RGn530 - Feasibility Pilot N/A
Enrolling by invitation NCT03430648 - Is Tau Protein Linked to Mobility Function?
Completed NCT03239561 - Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants Early Phase 1
Completed NCT03184467 - Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients Phase 2
Recruiting NCT04606420 - Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease Phase 2
Active, not recruiting NCT03676881 - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Recruiting NCT03487380 - Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease N/A
Recruiting NCT05328115 - A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease Phase 1
Recruiting NCT04149860 - Study With Lu AF87908 in Healthy Participants and Participants With Alzheimer's Disease Phase 1
Not yet recruiting NCT03208491 - [email protected]: Economic Assessment of Serious Games for the Management of Alzheimer's Disease and Related Disorders N/A
Withdrawn NCT02707978 - F 18 T807 Tau PET Imaging of Frontotemporal Dementia (FTD) Phase 2
Recruiting NCT04604600 - Multimodal Biomarkers for Diagnosis and Prognosis in VCI Phase 3
Recruiting NCT05077501 - Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of ACD856 Phase 1
Completed NCT04567745 - Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers Phase 1
Enrolling by invitation NCT05080777 - Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems N/A
Recruiting NCT04488419 - ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease Phase 3