TREAD: Time Restricted Eating Intervention for Alzheimer's Disease

TREAD: Time Restricted Eating Intervention for Alzheimer's Disease (NCT06548191) is a Phase 1 interventional studying Mild Cognitive Impairment and Alzheimer Disease, sponsored by University of California, San Diego. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Mild Cognitive Impairment, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Mild Cognitive Impairment subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Provision of signed and dated willing to sign a consent form 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. Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

BEHAVIORAL

Time-restricted eating

Fasting (abstinence from calorie-containing food or drink) during 14 h at night, with no caloric consumption after 8 pm to align with circadian rhythms

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Shiley Marcos Alzheimer's Disease Center

San Diego, California, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06548191), the sponsor (University of California, San Diego), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06548191 clinical trial studying?

Who can participate in NCT06548191?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06548191?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06548191. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06548191. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.