Status:
RECRUITING
TREAD: Time Restricted Eating Intervention for Alzheimer's Disease
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Mild Cognitive Impairment
Alzheimer Disease
Eligibility:
All Genders
60+ years
Phase:
PHASE1
Brief Summary
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 diagnose...
Detailed Description
Study Description: Our overarching hypothesis is that circadian alignment of food intake and biological clocks can reduce pathology and improve cognitive function in Alzheimer's disease (AD) patients....
Eligibility Criteria
Inclusion
- 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
- Persons, aged ≥60 years
- 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.
- Ability and willingness to complete cognitive evaluations, blood draw, actigraphy monitoring and to record fasting times daily.
- Daily night fasting \<12h at baseline. Ability and willingness to follow an eating protocol of prolonged night fasting for 14 h
- For cognitively normal living partners in the dyads group, scores \>26 in the Montreal Cognitive Assessment (MoCA) test administered at screening.
- Exclusion Criteria:
- Clinical diagnosis with a neurodegenerative condition other than MCI/AD.
- Presenting cognitive impairment not due to AD.
- Clinical diagnoses of diabetes.
- Actively using insulin in the past 6 months.
- Started a new medication (or changed doses) indicated for the treatment of MCI/AD in the last three months prior to enrollment.
- Currently taking any medication known to affect appetite, inlcuding but not limited to GLP-1 agonists.
- Any history of disordered eating, including difficulty swallowing and refusal to eat.
- Currently engaged in shift work.
- In treatment with another investigational drug.
- Body Mass Index (BMI) \<20. or \>35
Exclusion
Key Trial Info
Start Date :
April 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06548191
Start Date
April 23 2025
End Date
March 31 2026
Last Update
August 7 2025
Active Locations (1)
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1
Shiley Marcos Alzheimer's Disease Center
San Diego, California, United States, 92093