NCT06548191RecruitingPhase 1
TREAD: Time Restricted Eating Intervention for Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 26 May 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 20 Jul 2024
- Start date
- 23 Apr 2025
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- University of California, San Diego
- Diseases
- Alzheimer disease
- NCT number
- NCT06548191
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 60
- From 23 Apr 2025 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- In treatment with another investigational drug.
Other illness
- Clinical diagnosis with a neurodegenerative condition other than MCI/AD.
- Presenting cognitive impairment not due to AD.
- Clinical diagnoses of diabetes.
- Any history of disordered eating, including difficulty swallowing and refusal to eat.
Other
- Actively using insulin in the past 6 months.
- Currently engaged in shift work.
- Body Mass Index (BMI) \<20. or \>35
Who the study is looking for
- 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.
Criteria the registry did not label
- Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study.
Age in the registry: 60 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shiley Marcos Alzheimer's Disease Center Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.