TREAD: Time Restricted Eating Intervention for Alzheimer's Disease

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Aug 8, 2024

Keywords

ClinConnect Summary

The TREAD clinical trial is exploring whether a specific eating pattern, called time-restricted eating, can help improve sleep and brain function in older adults with Mild Cognitive Impairment (MCI) or early to moderate Alzheimer’s disease. In this study, participants will fast for 14 hours each night (meaning they will stop eating at 8 PM and not eat again until 10 AM the next day) for either 3 or 6 months. Researchers want to see if this fasting can lower certain signs of Alzheimer’s disease and improve thinking and sleep. They will also check if having a partner join in on the fasting makes it easier for participants to stick to the plan.

To be eligible for the trial, participants must be at least 60 years old and have a diagnosis of MCI or Alzheimer’s disease. They should be generally healthy, able to complete some simple tests, and currently fasting for less than 12 hours each night. Throughout the study, participants will visit the clinic three times, provide blood samples, take cognitive tests, keep a diary of their eating times, and wear a watch that tracks their activity. This trial is currently recruiting participants, and it aims to understand how effective this eating pattern might be for improving health in people with cognitive challenges.

Gender

ALL

Eligibility criteria

• • Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study.
• • Inclusion criteria
• • 1. Persons, aged ≥60 years
• • 2. In good general health as evidenced by medical history or diagnosed with clinical diagnosis of MCI/AD: meeting research consensus criteria for probable MCI or dementia due to AD, requiring positive amyloid biomarkers in brain or cerebrospinal fluid (CSF) obtained at their regular point of care or study referral no longer than 3 months prior to screening.
• • 3. Ability and willingness to complete cognitive evaluations, blood draw, actigraphy monitoring and to record fasting times daily.
• • 4. Daily night fasting \<12h at baseline. Ability and willingness to follow an eating protocol of prolonged night fasting for 14 h
• • 5. For cognitively normal living partners in the dyads group, scores \>26 in the Montreal Cognitive Assessment (MoCA) test administered at screening.
• Exclusion Criteria:
• • 1. Clinical diagnosis with a neurodegenerative condition other than MCI/AD.
• • 2. Presenting cognitive impairment not due to AD.
• • 3. Clinical diagnoses of diabetes.
• • 4. Actively using insulin in the past 6 months.
• • 5. Started a new medication (or changed doses) indicated for the treatment of MCI/AD in the last three months prior to enrollment.
• • 6. Currently taking any medication known to affect appetite, inlcuding but not limited to GLP-1 agonists.
• • 7. Any history of disordered eating, including difficulty swallowing and refusal to eat.
• • 8. Currently engaged in shift work.
• • 9. In treatment with another investigational drug.
• • 10. Body Mass Index (BMI) \<20. or \>35