NCT06548191 TREAD: Time Restricted Eating Intervention for Alzheimer's Disease
| NCT ID | NCT06548191 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of California, San Diego |
| Condition | Mild Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-04-23 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2025-04-23 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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
Contact & Investigator
Paula Desplats, PhD
PRINCIPAL INVESTIGATOR
University of California, San Diego
Frequently Asked Questions
Who can join the NCT06548191 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Mild Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06548191 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06548191 currently recruiting?
Yes, NCT06548191 is actively recruiting participants. Contact the research team at pdesplat@health.ucsd.edu for enrollment information.
Where is the NCT06548191 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT06548191 clinical trial?
NCT06548191 is sponsored by University of California, San Diego. The principal investigator is Paula Desplats, PhD at University of California, San Diego. The trial plans to enroll 60 participants.