TREAD: Time Restricted Eating Intervention for Alzheimer's Disease
Time-restricted eating for Alzheimer's: A new trial for cognitive health
Plain English Summary
TREAD: Time Restricted Eating Intervention for Alzheimer's Disease is a Phase 1 clinical trial sponsored by University of California, San Diego studying Mild Cognitive Impairment, Alzheimer Disease, Alzheimer's Disease. This trial tests if a 14-hour nightly fasting window can improve sleep, thinking, and reduce markers of Alzheimer's disease in people with mild cognitive impairment or early to moderate Alzheimer's. It is for individuals aged 60 and older who have been diagnosed with mild cognitive impairment or early to moderate Alzheimer's disease, and who currently fast for less than 12 hours at night. Participants will fast for 14 hours each night for 3 or 6 months, visit the clinic three times, provide blood samples, take cognitive tests, and track their eating times and activity. Alternatives include standard medical care for Alzheimer's and mild cognitive impairment, which may involve medications and lifestyle recommendations, but not specifically time-restricted eating. The trial aims to enroll 60 participants.
Official 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
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 60 years or older and have been diagnosed with mild cognitive impairment or early to moderate Alzheimer's disease, with confirmed biomarkers. You must be able to follow a 14-hour nightly fasting schedule and be willing to wear an activity tracker and record your eating times. You cannot join if you have other neurodegenerative conditions, significant cognitive impairment not due to Alzheimer's, diabetes requiring insulin, or have recently changed Alzheimer's medications. Individuals with a history of eating disorders, those currently on medications affecting appetite (like GLP-1 agonists), or those with a BMI below 20 or above 35 will also be excluded. This trial is studying Mild Cognitive Impairment, Alzheimer Disease, Alzheimer's Disease, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how well participants can stick to the 14-hour nightly fasting schedule, indicating if this eating pattern is practical for people with mild cognitive impairment or Alzhei The specific primary outcome measures are: Feasibility: assessed by computing the number of nights achieving the goal fasting time of 14 h. (3 and 6 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.
Why This Trial Matters
This trial explores time-restricted eating as a potential non-pharmacological approach to slow cognitive decline and improve sleep in individuals with early-stage Alzheimer's or mild cognitive impairm This research targets Mild Cognitive Impairment, Alzheimer Disease, Alzheimer's Disease, where improved treatment options are needed.
Investor Insight
This Phase 1 trial, while early stage, investigates a novel dietary intervention for a large and growing market of Alzheimer's patients, with potential for broad applicability if proven effective and Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if this trial is right for you, especially considering your current health and any other conditions you may have. Be prepared to commit to a strict eating schedule, stopping all food and drink (except water) by 8 pm and not eating again until 10 am the next morning. You will need to regularly visit the clinic, provide blood samples, and use a diary or app to track your eating times, along with wearing an activity tracker. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: CROSSOVER
- Masking: DOUBLE
- Enrollment: 60 participants
Interventions
- 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
Primary Outcomes
- Feasibility: assessed by computing the number of nights achieving the goal fasting time of 14 h. (3 and 6 months)
Secondary Outcomes
- Effects of TRE on activity rhythms measured as steps/day using an accelerometer (baseline, 3 and 6 months)
- Effects of TRE on skin temperature rhythms measured in F using a smart sensor. (baseline, 3 and 6 months)
- Effects of TRE on sleep quantity (as hours/night) using a smart sensor. (Baseline, 3 and 6 months)
- Effects of TRE on sleep quality (determined by a sleep score) using a smart sensor. (baseline, 3 and 6 months)
- Explore the effects of TRE on pathology in MCI/AD patients (baseline, 3 and 6 months)
Full 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
Trial Locations
- Shiley Marcos Alzheimer's Disease Center, San Diego, California, United States
Frequently Asked Questions
What is clinical trial NCT06548191?
NCT06548191 is a Phase 1 INTERVENTIONAL study titled "TREAD: Time Restricted Eating Intervention for Alzheimer's Disease." It is currently recruiting and is sponsored by University of California, San Diego. The trial targets enrollment of 60 participants.
What conditions does NCT06548191 study?
This trial investigates treatments for Mild Cognitive Impairment, Alzheimer Disease, Alzheimer's Disease. The primary condition under study is Mild Cognitive Impairment.
What treatments are being tested in NCT06548191?
The interventions being studied include: Time-restricted eating (BEHAVIORAL). 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
What does Phase 1 mean for NCT06548191?
Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.
What is the current status of NCT06548191?
This trial is currently "Recruiting." It started on 2025-04-23. The estimated completion date is 2026-12-31.
Who is sponsoring NCT06548191?
NCT06548191 is sponsored by University of California, San Diego. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06548191?
The trial aims to enroll 60 participants. The trial is currently recruiting and accepting new participants.
How is NCT06548191 designed?
This is a interventional study, uses randomized allocation, follows a crossover design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT06548191?
The primary outcome measures are: Feasibility: assessed by computing the number of nights achieving the goal fasting time of 14 h. (3 and 6 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06548191 being conducted?
This trial is being conducted at 1 site, including San Diego, California (United States).
Where can I find official information about NCT06548191?
The official record for NCT06548191 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06548191. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06548191 testing in simple terms?
This trial tests if a 14-hour nightly fasting window can improve sleep, thinking, and reduce markers of Alzheimer's disease in people with mild cognitive impairment or early to moderate Alzheimer's. It is for individuals aged 60 and older who have been diagnosed with mild cognitive impairment or early to moderate Alzheimer's disease, and who currently fast for less than 12 hours at night.
Why is this trial significant?
This trial explores time-restricted eating as a potential non-pharmacological approach to slow cognitive decline and improve sleep in individuals with early-stage Alzheimer's or mild cognitive impairm
What are the potential risks of participating in NCT06548191?
The main risk is difficulty adhering to the strict 14-hour fasting schedule, which could lead to frustration or not achieving the study's goals. Potential side effects could include hunger, fatigue, or changes in mood due to the fasting period, though these are generally manageable. There's a small risk of experiencing digestive discomfort or changes in bowel habits as your body adjusts to the new eating pattern. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06548191?
Ask your doctor if this trial is right for you, especially considering your current health and any other conditions you may have. Be prepared to commit to a strict eating schedule, stopping all food and drink (except water) by 8 pm and not eating again until 10 am the next morning. You will need to regularly visit the clinic, provide blood samples, and use a diary or app to track your eating times, along with wearing an activity tracker. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06548191 signal from an investment perspective?
This Phase 1 trial, while early stage, investigates a novel dietary intervention for a large and growing market of Alzheimer's patients, with potential for broad applicability if proven effective and This is a Phase 1 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will fast for 14 hours each night for 3 or 6 months, visit the clinic three times, provide blood samples, take cognitive tests, and track their eating times and activity. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.