RecruitingPhase 1NCT06548191

TREAD: Time Restricted Eating Intervention for Alzheimer's Disease


Sponsor

University of California, San Diego

Enrollment

60 participants

Start Date

Apr 23, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study (called TREAD) is testing whether time-restricted eating — limiting when you eat each day to a certain window of hours — can benefit people with Alzheimer's disease or mild cognitive impairment (MCI). Researchers believe that aligning eating patterns with the body's natural daily rhythm may help brain health. Participants will be asked to extend their overnight fast and track their eating times. **You may be eligible if...** - You are 60 years of age or older - You have been diagnosed with MCI (mild cognitive impairment) or early Alzheimer's disease, confirmed by positive amyloid biomarkers in the brain or spinal fluid within the past 3 months - You currently fast less than 12 hours overnight - You are willing and able to complete cognitive tests, blood draws, wear an activity monitor, and record your eating times daily **You may NOT be eligible if...** - You do not have confirmed amyloid markers of Alzheimer's - You already fast 12 or more hours overnight - You are unable or unwilling to follow the eating protocol - You have conditions that make extended fasting unsafe (such as certain metabolic disorders) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALTime-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)

Shiley Marcos Alzheimer's Disease Center

San Diego, California, United States

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NCT06548191


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