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NCT06121986 · ClinicalTrials.gov registry record · NA
A Scalable Nutrition Adherence Intervention
A NA study of Alzheimer Disease and Mild Cognitive Impairment, sponsored by Florida State University.
- Active
- Registry status
- NA
- Development phase
- 61
- Enrollment target
- 1
- Study location
NCT06121986: Active NA study of Alzheimer Disease and Mild Cognitive Impairment, sponsored by Florida State University.
NCT06121986 is a NA study of Alzheimer Disease and Mild Cognitive Impairment that is active but no longer recruiting, run by Florida State University. The registered enrollment target is 61 participants, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06121986, a NA study of Alzheimer Disease and Mild Cognitive Impairment, is active but no longer recruiting, sponsored by Florida State University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 61 participants
- Enrollment target
- 1
- Study location
Study Summary
Objective 1: To scale-up the nutrition adherence intervention for testing in racially diverse rural communities in North Florida. The investigators hypothesize that: 1\. The protocol will produce at least 75% of participants obtaining measurable levels of urine ketones (e.g., good adherence) in the Modified Mediterranean-Ketogenic diet (MMKD) group and an average score of \>6 on the MEDAS questionnaire in the Mediterranean group during the 10-week program. Further, we hypothesize that the use of ongoing monthly support groups will bolster long-term adherence. Objective 2: To evaluate the effects of adherence to Mediterranean versus MMKD on novel gut-brain axis markers of Alzheimer's disease pathogenesis in individuals with mild cognitive impairment compared to cognitively normal older adults. The investigators hypothesize that individuals with mild cognitive impairment will: 1. Have greater evidence of gut dysbiosis at baseline than cognitively normal controls and 2. Will demonstrate greater increases in beneficial gut microbial metabolites in response to adherence to Mediterranean-Ketogenic nutrition and the Mediterranean diet compared to CN controls.
Primary Outcome
Participants will show measurable levels of ketones using at-home urinalysis test strips by week 10 of the intervention, as evidenced by small trace amounts of ketones on the urine strips.
Conditions Studied
Interventions
- BEHAVIORAL Improving Cognitive Aging through Nutrition (ICAN) Adherence Program
- BEHAVIORAL Improving Cognitive Aging through Nutrition, Mediterranean diet
Study Locations (1)
Florida
- 2010 Levy Ave - Center for Translational Behavioral Science - Tallahassee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2023-11-30 |
| Est. Completion | 2026-05 |
| Phase | NA |
What the registry record for NCT06121986 still lists
NCT06121986 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Improving Cognitive Aging through Nutrition (ICAN) Adherence Program is the first listed.
NCT06121986 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06121986 about?
NCT06121986 is a clinical study titled "A Scalable Nutrition Adherence Intervention". Objective 1: To scale-up the nutrition adherence intervention for testing in racially diverse rural communities in North Florida. The investigators hypothesize that: 1\. The protocol will produce at least 75% of participants obtaining measurable levels of urine ketones (e.g., good adherence) in th...
What is the current status of trial NCT06121986?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 61 participants. The study started on 2023-11-30. Estimated completion is 2026-05.
What conditions does trial NCT06121986 study?
This clinical trial studies the following conditions: Alzheimer Disease, Mild Cognitive Impairment, Adherence.
What interventions are being tested in trial NCT06121986?
The interventions under investigation include: Improving Cognitive Aging through Nutrition (ICAN) Adherence Program (BEHAVIORAL), Improving Cognitive Aging through Nutrition, Mediterranean diet (BEHAVIORAL).
Who is sponsoring clinical trial NCT06121986?
This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06121986 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06121986's enrollment target sits among peer trials
61 185th of 306 higher than 121 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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