Time-restricted eating intervention for Alzheimer's disease
TREAD: Time Restricted Eating Intervention for Alzheimer's Disease
This study is testing if eating only during a 14-hour window at night can help people with Mild Cognitive Impairment or early Alzheimer's disease think better and sleep more soundly.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT06548191 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether restricting eating to a 14-hour window at night can reduce cognitive decline and sleep disturbances in patients with Mild Cognitive Impairment (MCI) or early to moderate Alzheimer's disease (AD). The study will assess the feasibility of this time-restricted eating (TRE) approach over a period of 3 to 6 months, comparing outcomes between participants who fast for 14 hours versus those who fast for less than 12 hours. Researchers will evaluate various metabolic and pathological markers to determine the potential benefits of TRE on cognitive function and disease progression.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 60 and older diagnosed with Mild Cognitive Impairment or early to moderate Alzheimer's disease.
Not a fit: Patients who are not willing or able to comply with the fasting protocol or who have severe cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a novel dietary approach to slow cognitive decline and improve quality of life for patients with Alzheimer's disease.
How similar studies have performed: While the approach of time-restricted eating is gaining interest, this specific application in Alzheimer's disease is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Diego, California
- Shiley Marcos Alzheimer's Disease Center — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: Paula Desplats, PhD — University of California, San Diego
- Study coordinator: Paula Desplats, PhD
- Email: pdesplat@health.ucsd.edu
- Phone: 858-534-4839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.