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NCT06429124 · ClinicalTrials.gov record · last posted 2025-06-06

Time Restricted Eating in Alzheimer's Disease

Study acronym: TREAD
StatusRecruiting
PhaseNot applicable
Started2023-03-15
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 6, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
from the ClinicalTrials.gov record
This pilot and feasibility study will enable the research team to determine the feasibility of implementing a time-restricted eating regimen among adults with mild cognitive impairment (MCI) and the impact of time-restricted eating on cognitive performance and biomarkers of metabolic health in this population. Study staff will execute the specific aims using a pre-post, non-randomized study design in which all participants receive the intervention. The intervention is a 16/8 time-restricted eating regimen characterized by fasting for 16 hours and eating within an 8-hour window on 5 days per week for 3 months. Assessments will be performed at baseline and after the 3-month time-restricted eating intervention with the following outcome measures. Outcome measures for feasibility include participant recruitment, retention and metrics of acceptability, safety, and adherence to the intervention. Outcome measures for cognitive performance and metabolic health include neuropsychological tests, blood biomarkers, and surveys of psychological well-being.

Amendment record 4 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 4 times since 2024-05-20; most recent amendment 2025-06-03. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

Trial Details
NCT Number NCT06429124
Lead Sponsor St. Joseph's Hospital and Medical Center, Phoenix
Collaborators: Arizona State University, Karlsruhe Institute of Technology, Mayo Clinic
Conditions Mild Cognitive Impairment (MCI)
Enrollment 30 participants
Start Date 2023-03-15
Primary Completion 2025-12 (estimated)
Study Completion 2026-03-14 (estimated)
Updated on ClinicalTrials.gov 2025-06-06