Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06029894
Status:
RECRUITING
Last Update Posted:
2024-01-16
First Post:
2023-08-10
Brief Title:
Improving Sleep and AD Biomarkers
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Improving Sleep and Alzheimers Disease AD Biomarkers A Pilot Randomized Clinical Trial RCT of Citicoline
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 Alzheimers 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 Alzheimers 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
The investigators are interested in learning more about a dietary supplement called citicoline and how it helps sleep cognition and markers of Alzheimers 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 Alzheimers 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 Alzheimers 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R61AG080606-01 | NIH | None | httpsreporternihgovquickSearch1R61AG080606-01 |