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NCT03472664 · ClinicalTrials.gov registry record · NA
Brain Energy for Amyloid Transformation in Alzheimer's Disease Study
A NA study of Alzheimer Disease and Mild Cognitive Impairment, sponsored by Wake Forest University Health Sciences.
- Recruiting
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT03472664 is a NA study of Alzheimer Disease and Mild Cognitive Impairment that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 120 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03472664, a NA study of Alzheimer Disease and Mild Cognitive Impairment, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.
- RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
The Brain Energy for Amyloid Transformation in AD (Alzheimer's disease) or BEAT-AD study will compare the effects of a ketogenic low-carbohydrate diet and a low-fat diet in adults with mild cognitive impairment. The data collected will help determine whether diet interventions induce changes in cognitive function, cerebral blood flow, and levels of certain proteins and hormones in body fluids. The study will include volunteers who have mild cognitive impairment, who will be randomly assigned to receive either a ketogenic low-carbohydrate diet or a low-fat diet for 16-weeks, with follow-up assessment 8 weeks after diet completion. Study measures, clinic visits and phone sessions will occur at baseline and throughout the 24-week study. Participant will follow either a low-carbohydrate or low-fat diet that will be individually planned with help from a study dietitian. After completing the study diet for 16 weeks, participants will resume their normal diet. The final visits will occur at week 24 (8 weeks after the completing the diet). At the end of the 24-week study, participants will be given the opportunity to meet with the study dietitian for education and assistance with planning a healthy diet.
Conditions Studied
Interventions
- OTHER low carbohydrate/high fat diet
- OTHER low fat/high carbohydrate diet
Study Locations (1)
North Carolina
- Wake Forest Baptist Medical Center - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2018-07-16 |
| Est. Completion | 2026-04 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03472664
The ClinicalTrials.gov registry entry for NCT03472664 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (96% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which low carbohydrate/high fat diet is the first listed.
NCT03472664 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT03472664 about?
NCT03472664 is a clinical study titled "Brain Energy for Amyloid Transformation in Alzheimer's Disease Study". The Brain Energy for Amyloid Transformation in AD (Alzheimer's disease) or BEAT-AD study will compare the effects of a ketogenic low-carbohydrate diet and a low-fat diet in adults with mild cognitive impairment. The data collected will help determine whether diet interventions induce changes in cogn...
What is the current status of trial NCT03472664?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2018-07-16. Estimated completion is 2026-04.
What conditions does trial NCT03472664 study?
This clinical trial studies the following conditions: Alzheimer Disease, Mild Cognitive Impairment.
What interventions are being tested in trial NCT03472664?
The interventions under investigation include: low carbohydrate/high fat diet (OTHER), low fat/high carbohydrate diet (OTHER).
Who is sponsoring clinical trial NCT03472664?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03472664 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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