Actively Recruiting
TREAD: Time Restricted Eating Intervention for Alzheimer's Disease
Led by University of California, San Diego · Updated on 2026-03-06
60
Participants Needed
1
Research Sites
88 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
TREAD: Time Restricted Eating Intervention for Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- In good general health or diagnosed with MCI/AD meeting research consensus criteria for probable MCI or dementia due to AD, with positive amyloid biomarkers in brain or cerebrospinal fluid within 3 months prior to screening
- Ability and willingness to complete cognitive tests, blood draws, wear activity monitoring devices, and record fasting times daily
- Nightly fasting less than 12 hours at baseline and willingness to follow a 14-hour nightly fasting eating protocol
- For cognitively normal living partners in dyads, Montreal Cognitive Assessment (MoCA) score above 26 at screening
You will not qualify if you...
- Diagnosis of a neurodegenerative condition other than MCI/AD
- Cognitive impairment not caused by Alzheimer's disease
- Clinical diagnosis of diabetes
- Use of insulin in the past 6 months
- Started or changed medication for MCI/AD within 3 months prior to enrollment
- Current use of medications affecting appetite, including GLP-1 agonists
- History of disordered eating, swallowing difficulties, or refusal to eat
- Currently engaged in shift work
- Participation in another investigational drug treatment
- Body Mass Index (BMI) less than 20 or greater than 35
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shiley Marcos Alzheimer's Disease Center
San Diego, California, United States, 92093
Actively Recruiting
Research Team
P
Paula Desplats, PhD
CONTACT
O
Olivia Ott, M.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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