NCT06548191 · Phase 1 · RECRUITING
TREAD: Time Restricted Eating Intervention for Alzheimer's Disease
This trial tests whether eating within a 10-hour daytime window — fasting for 14 hours each night — can reduce sleep problems, slow cognitive decline, and lower biological markers of Alzheimer's disease in people already diagnosed with MCI or early-to-moderate Alzheimer's. It also tests whether having a partner fast alongside you improves adherence. This is a Phase 1 trial, meaning the primary focus is safety and feasibility, not proof that it works.
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
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 2026-05-26