NCT06429124 · RECRUITING

Time Restricted Eating in Alzheimer's Disease

This small study tests whether people with mild cognitive impairment can stick to time-restricted eating: fasting 16 hours and eating within 8 hours, five days a week for three months. Researchers will track how doable it is, plus memory and thinking tests and metabolic blood markers. It is a pilot with no control group, so it cannot prove benefit.

You may qualify if

  • 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.

You're excluded if

  • Diabetes mellitus that requires insulin treatment or is not well managed.
  • An eating disorder.
  • A contraindication to time-restricted eating.
  • Daily eating window \<11 hours/day on ≥3 days/week.
  • MMSE score ≤9 or patients diagnosed with severe dementia by a clinician.
  • In the opinion of the investigator, participation would not be in the best interest of the subject.
  • Taking prescription medications twice a day that need to be taken with food.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2025-06-06

View full record on ClinicalTrials.gov

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