TREAD: Time Restricted Eating Intervention for Alzheimer's Disease

NCT06548191 | Recruiting Phase 1 DMC

• 2 other identifiers: RD10061932R61AG085253
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Alzheimer Disease; Mild Cognitive Impairment; Alzheimer's Disease

Keywords

Time-Restricted Eating; Intermittent Fasting; Prolonged Nightly Fasting; Mild Cognitive Impairment; Alzheimer Disease; Circadian Rhythms; Cognition; Neuropathology

Outcome Measures

Primary Outcomes (1)

• Feasibility: assessed by computing the number of nights achieving the goal fasting time of 14 h.

  Test the feasibility of a Time-restricted eating intervention in patients with MCI or AD by quantification the number of days during the intervention period when the particpants reached the goal intervention fasting time of 14 h, b) increased fasting of \>12 h and \<14 h.

  3 and 6 months

Secondary Outcomes (9)

• 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

Study Arms (2)

Delayed-Start Intervention

ACTIVE COMPARATOR

Participants will continue their regular eating schedule (nightly fasting for less than 12 h) during the first 3 months and start time-restricted eating intervention ( 14 h of nightly fasting) for the next 3 months.

Behavioral: Time-restricted eating

Intervention

ACTIVE COMPARATOR

Participants will follow the time-restricted regimen (14 h of nightly fasting) for 6 months.

Behavioral: Time-restricted eating

Interventions

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

Also known as: Prolonged Nightly Fasting

Delayed-Start Intervention; Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons, aged ≥60 years
• 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.
• Ability and willingness to complete cognitive evaluations, blood draw, actigraphy monitoring and to record fasting times daily.
• Daily night fasting \<12h at baseline. Ability and willingness to follow an eating protocol of prolonged night fasting for 14 h
• For cognitively normal living partners in the dyads group, scores \>26 in the Montreal Cognitive Assessment (MoCA) test administered at screening.

You may not qualify if:

• Clinical diagnosis with a neurodegenerative condition other than MCI/AD.
• Presenting cognitive impairment not due to AD.
• Clinical diagnoses of diabetes.
• Actively using insulin in the past 6 months.
• Started a new medication (or changed doses) indicated for the treatment of MCI/AD in the last three months prior to enrollment.
• Currently taking any medication known to affect appetite, inlcuding but not limited to GLP-1 agonists.
• Any history of disordered eating, including difficulty swallowing and refusal to eat.
• Currently engaged in shift work.
• In treatment with another investigational drug.
• Body Mass Index (BMI) \<20. or \>35

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Shiley Marcos Alzheimer's Disease Center

San Diego, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Intermittent Fasting

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Fasting; Feeding Behavior; Behavior

Study Officials

• Paula Desplats, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paula Desplats, PhD

CONTACT

858-534-4839; pdesplat@health.ucsd.edu

Olivia Ott, M.S.

CONTACT

TREAD@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding disease condition and arm
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neuroscience

Model Details: TREAD will enroll 40 older adults (60+ years) with cognitive impairment and clinically diagnosed with Mild Cognitive Impairment (MCI) or early to moderate AD; and 20 cognitively normal subjects (18+ years). The investigators will recruit individual participants with a diagnosis of MCI/AD (n=20 subjects) and 20 dyads of participants (n=40 subjects) composed of an MCI/AD patient and a cognitively normal living partner. This design is necessary to evaluate how feasible and burdensome is to follow a time-restricted eating pattern for individuals with cognitive impairment. Individual and dyad participants will be randomized in equal ratios to the complete prolonged nightly fasting intervention (14 h fast with no energy intake after 8 pm for 6 months) or to a delayed-start prolonged nightly fasting intervention (3 initial months of unrestricted eating patterns followed by 3 months of 14 h fast with no energy intake after 8 pm) using a random permuted-block design.

Study Record Dates

• First Submitted: July 20, 2024
• First Posted: August 12, 2024
• Study Start: April 23, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 6, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)