NCT06429124Recruiting
Time Restricted Eating in Alzheimer's Disease
Time-Restricted Eating in Alzheimer's Disease : The T.R.E.A.D Trial
Source: ClinicalTrials.gov · Last updated 6 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 29 Apr 2024
- Start date
- 15 Mar 2023
- Primary completion date
- Dec 2025
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Diseases
- Alzheimer disease
- NCT number
- NCT06429124
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 15 Mar 2023 to the primary completion date, Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking prescription medications twice a day that need to be taken with food.
Other illness
- Diabetes mellitus that requires insulin treatment or is not well managed.
- An eating disorder.
- MMSE score ≤9 or patients diagnosed with severe dementia by a clinician.
Other
- A contraindication to time-restricted eating.
- Daily eating window \<11 hours/day on ≥3 days/week.
- In the opinion of the investigator, participation would not be in the best interest of the subject.
Who the study is looking for
- Male or Female outpatients 55-89 years of age.
- Meet Mayo Clinic Criteria for MCI.
- If taking medications that may affect one or more study outcome measures(such as donepezil and memantine),the participant must be on a stable dose for at least the preceding 3 months.
- A body mass index ≥18.5 and \<40.0 kg/m2.
- Access to the internet through computer or smartphone.
- Must have a collateral informant/study partner(e.g. spouse or adult child) who has significant direct contact with the patient and who is willing to accompany the patient to specified clinic visits and be available for telephone visits/Interviews.
- An education level \> 8 years.
- A proficiency in speaking and reading English or having a family member who is proficient in reading and speaking English and is willing to serve as a translator.
- Vision and hearing must be sufficient to comply with study procedures.
Age in the registry: 55 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Arizona State University, College of Health Solutions Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Barrow Neurological Institute, Division of Alzheimer's Disease Coordinator of this site? Confirm its status | Phoenix | United States | Enrolling by invitation |
This page is information, not medical advice. Discuss any trial with your doctor.