TREAD: Time Restricted Eating Intervention for Alzheimer's Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 60 Years and older
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 12 months, 3 months
- Procedures mentioned: Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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"
- "The INT group will follow the TRE regimen for 12 months."
- "The DS-INT group will practice their regular eating pattern for 3 months (nightly fasting \<12 h) followed by 3 months of TRE."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether not eating for 14 hours each night can help sleep, memory, and signs of Alzheimer's disease. It is for adults age 60 or older with mild cognitive impairment (milder memory and thinking problems) or early to moderate Alzheimer's disease, and includes healthy living partners. Researchers will also test whether people can follow this eating plan for 3 to 6 months and whether doing it with a partner helps.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 60 or older.
- Be in good general health or have a diagnosis of mild cognitive impairment or dementia due to Alzheimer's disease.
- For those with a diagnosis, have a positive test for amyloid, a protein linked to Alzheimer's, in the brain or fluid around the brain and spine. The test must be from within 3 months before screening.
- Sign a consent form and be willing and available to follow all study steps.
- Be able and willing to take memory and thinking tests, give blood samples, wear an activity tracker, and record fasting times each day.
- Currently go less than 12 hours without eating at night, and be able and willing to increase this to 14 hours.
- Healthy living partners in the paired group must score above 26 on the Montreal Cognitive Assessment, a memory and thinking test, at screening.
Who can't join
- Have another disease that damages the brain or nerves, or thinking problems not caused by Alzheimer's disease.
- Have diabetes or have used insulin in the past 6 months.
- Started a new medicine for mild cognitive impairment or Alzheimer's, or changed its dose, in the 3 months before joining.
- Take medicine known to affect appetite, including GLP-1 medicines.
- Have any history of eating problems, including trouble swallowing or refusing to eat.
- Currently do shift work.
- Are being treated with another experimental drug.
- Have a body mass index (BMI), a measure based on height and weight, below 20 or above 35.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
CA
- Shiley Marcos Alzheimer's Disease Center · San Diego, CA 92093Paula Desplats · Study contact · TREAD@health.ucsd.eduPaula Desplats, PhD · Principal investigatorGabriel Leger, MD · Sub-investigatorMore trials in San Diego