RECRUITING

TREAD: Time Restricted Eating Intervention for Alzheimer's Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn if restricting the time of eating to allow for prolonged fasting at night may reduce sleep disturbances, cognitive decay, and pathology in patients diagnosed with Mild Cognitive Impairment (MCI) or early to moderate Alzheimer's disease (AD). It will also learn about the feasibility of practicing 14 h of nightly fasting in this group of older adults. The main questions it aims to answer are: * Does prolonged nightly fasting of 14 h can reduce markers of AD pathology and aging and reduce cognitive and sleep alterations in MCI and AD patients? * Can patients with MCI and early /moderate AD sustain time-restricted eating for 3 to 6 months? Researchers will compare participants who fast for 14 h per night during 3 months to those who fast for less than 12 h/night. Researchers will also compare participants that fast for 3 months to those who fast during 6 months, to determine the effective duration of the intervention. Finally, researchers will evaluate whether following the time-restricted eating diet alongside a partner actively following the same diet, will increase adherence to the protocol compared to subjects that fast alone. Participants will: * Fast for 14 h a night (stop eating at 8 pm and start eating the following morning at 10 am) for 3 or 6 months * Visit the clinic three times (at the beginning of the study, 6 and 12 months later) * Provide blood samples and take a cognitive test during clinic visits * Keep a diary (or use an app on a smart phone) to record time of eating * Wear an activity tracker watch

Official Title

TREAD: Time Restricted Eating Intervention for Alzheimer's Disease

Quick Facts

Study Start:2025-02
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06548191

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Clinical diagnosis with a neurodegenerative condition other than MCI/AD.
  2. 2. Presenting cognitive impairment not due to AD.
  3. 3. Clinical diagnoses of diabetes.
  4. 4. Actively using insulin in the past 6 months.
  5. 5. Started a new medication (or changed doses) indicated for the treatment of MCI/AD in the last three months prior to enrollment.
  6. 6. Currently taking any medication known to affect appetite, inlcuding but not limited to GLP-1 agonists.
  7. 7. Any history of disordered eating, including difficulty swallowing and refusal to eat.
  8. 8. Currently engaged in shift work.
  9. 9. In treatment with another investigational drug.
  10. 10. Body Mass Index (BMI) \<20. or \>35

Contacts and Locations

Study Contact

Paula Desplats, PhD
CONTACT
858-534-4839
pdesplat@health.ucsd.edu
Olivia Ott, M.S.
CONTACT
o1ott@health.ucsd.edu

Principal Investigator

Paula Desplats, PhD
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

Shiley Marcos Alzheimer's Disease Center
San Diego, California, 92093
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Paula Desplats, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02
Study Completion Date2026-05

Study Record Updates

Study Start Date2025-02
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

  • Time-Restricted Eating
  • Intermittent Fasting
  • Prolonged Nightly Fasting
  • Mild Cognitive Impairment
  • Alzheimer Disease
  • Circadian Rhythms
  • Cognition
  • Neuropathology

Additional Relevant MeSH Terms

  • Mild Cognitive Impairment
  • Alzheimer Disease