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Search / Trial NCT06429124

Time Restricted Eating in Alzheimer's Disease

Launched by ST. JOSEPH'S HOSPITAL AND MEDICAL CENTER, PHOENIX · May 20, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Alzheimer'S Disease Mild Cognitive Impairment Intermittent Fasting Nutritional Strategies Time Restricted Eating

ClinConnect Summary

The TREAD trial is studying whether a specific eating schedule can help improve cognitive health in older adults with mild cognitive impairment (MCI). This eating plan, called time-restricted eating, involves fasting for 16 hours each day and eating within an 8-hour window, five days a week, for three months. The researchers want to see how well participants stick to this plan and if it has any positive effects on their thinking abilities and overall health.

To be eligible for this study, participants need to be between 60 and 80 years old, have a diagnosis of MCI, and have a body mass index (BMI) between 18.5 and 40.0. They should also have internet access and a supportive family member to help them with the study activities. Participants will complete assessments at the beginning and end of the study to measure changes in cognitive performance, health markers, and well-being. This trial is currently recruiting participants and aims to gather important information about the potential benefits of time-restricted eating for people with MCI.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Male or Female outpatients 55-89 years of age.
  • 2. Meet Mayo Clinic Criteria for MCI.
  • 3. 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.
  • 4. A body mass index ≥18.5 and \<40.0 kg/m2.
  • 5. Access to the internet through computer or smartphone.
  • 6. 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.
  • 7. An education level \> 8 years.
  • 8. 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.
  • 9. Vision and hearing must be sufficient to comply with study procedures.
  • Exclusion Criteria:
  • 1. Diabetes mellitus that requires insulin treatment or is not well managed.
  • 2. An eating disorder.
  • 3. A contraindication to time-restricted eating.
  • 4. Daily eating window \<11 hours/day on ≥3 days/week.
  • 5. MMSE score ≤9 or patients diagnosed with severe dementia by a clinician.
  • 6. In the opinion of the investigator, participation would not be in the best interest of the subject.
  • 7. Taking prescription medications twice a day that need to be taken with food.

About St. Joseph's Hospital And Medical Center, Phoenix

St. Joseph's Hospital and Medical Center, located in Phoenix, Arizona, is a leading healthcare institution dedicated to providing high-quality patient care and advancing medical research. As a prominent clinical trial sponsor, the hospital is committed to exploring innovative treatments and therapies that enhance patient outcomes. With a focus on ethical research practices and collaboration with multidisciplinary teams, St. Joseph’s is at the forefront of clinical trials that address a wide range of medical conditions, ensuring rigorous scientific standards while prioritizing patient safety and well-being.

Locations

Phoenix, Arizona, United States

Phoenix, Arizona, United States

Patients applied

0 patients applied

Trial Officials

Yonas E Geda, MD, MSc

Principal Investigator

Barrow Neurological Institute, Alzheimer's Disease and Cognitive Disorders Division

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported