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Behavioural Intervention

Time-Restricted Eating for Alzheimer's Disease (TREAD Trial)

Phase 1
Waitlist Available
Led By Paula Desplats, PhD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Persons aged 65 years and above
Be older than 65 years old
Must not have
Clinical diagnosis with a neurodegenerative condition other than MCI/AD
Clinical diagnoses of diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights

Summary

This trial aims to investigate if fasting for 14 hours at night can help reduce sleep problems, cognitive decline, and disease progression in individuals with Mild Cognitive Impairment (MCI) or early to

Who is the study for?
This trial is for adults with Mild Cognitive Impairment or early to moderate Alzheimer's Disease who are interested in trying a time-restricted eating pattern. Participants will need to fast for 14 hours nightly and be willing to visit the clinic three times, provide blood samples, take cognitive tests, and track their eating habits.
What is being tested?
The study is testing if fasting for 14 hours each night can reduce symptoms of Alzheimer's Disease like sleep problems and memory loss. It compares people who fast less than 10 hours with those who do it for longer periods (6 or 12 months) and checks if having a partner doing the same helps stick to the diet.
What are the potential side effects?
Potential side effects may include hunger, irritability, or difficulty sleeping during adjustment to the new eating schedule. Long-term effects are unknown but could involve nutritional deficiencies or changes in metabolism.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a neurodegenerative condition that is not mild cognitive impairment or Alzheimer's disease.
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I have been diagnosed with diabetes.
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My cognitive issues are not caused by Alzheimer's disease.
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I have been using insulin for the last 6 months.
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I am taking medication that affects my appetite.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility: assessed by computing the number of nights achieving the goal fasting time of 14 h.
Secondary study objectives
Effects of TRE on activity rhythms measured as steps/day using an accelerometer
Effects of TRE on skin temperature rhythms measured in F using a Fitbit smart sensor.
Effects of TRE on sleep quality (determined by a sleep score) using a smart sensor.
+6 more

Trial Design

2Treatment groups
Active Control
Group I: Delayed-Start InterventionActive Control1 Intervention
Participants will continue thier regular eating schedule (nightly fasting for less than 10 h) during the first 6 months and start time-restricted eating intervention ( 14 h of nightly fasting) for the next 6 months.
Group II: InterventionActive Control1 Intervention
Participants will follow the time-restricted regimen (14 h of nightly fasting) for 12 months.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,157 Previous Clinical Trials
1,571,359 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,943 Total Patients Enrolled
Paula Desplats, PhDPrincipal InvestigatorUniversity of California, San Diego
~40 spots leftby Aug 2025
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