A Phase 1 interventional study of Time-restricted eating in Mild Cognitive Impairment, Alzheimer Disease and Alzheimer's Disease, sponsored by University of California, San Diego. Recruiting at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by University of California, San Diego · Phase 1, Interventional, and Treatment
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:
Participants will:
Study Description: Our overarching hypothesis is that circadian alignment of food intake and biological clocks can reduce pathology and improve cognitive function in Alzheimer's disease (AD) patients. The rationale for this proposal is that the prolonged nightly fasting form of Time-restricted eating (TRE) aligns food intake with the daytime "wake phase" of the biological clock, optimizing nutrient processing, and may modulate disease trajectory in AD. This Pilot study will test the feasibility and safety of TRE, consisting of 14 hours of night fasting for 3 or 6 months, in patients along the AD continuum and will explore the outcomes of this intervention on markers of aging and AD pathology. Results from this study will provide a strong scientific justification and will optimize the methods for a larger trial to determine the clinical efficacy of TRE to mitigate disease progression in AD and related dementias.
Objectives:
Primary Objective: Test the feasibility of a TRE intervention (TREAD) among patients with Mild Cognitive Impairment (MCI) or AD.
Secondary Objectives: Explore the effects of TRE on metabolic and pathological markers in MCI/AD patients.
Endpoints:
Primary Endpoint: Feasibility, safety, cognition, and metabolic indicators. Secondary Endpoints: Biomarkers of AD pathology, sleep and activity, and markers of epigenetic aging.
Study Population:
Adult subjects (female and males, ≥60 years old) with normal cognition or with a clinical diagnosis of MCI/AD (meeting research consensus criteria for probable MCI or dementia due to AD).
Phase: Early phase 1
Description of Sites/Facilities Enrolling Participants:
Shiley-Marcos Alzheimer's disease Research Center (SMARDC) at the University of California San Diego (UCSD) La Jolla campus.
Description of Study Intervention: The investigators will enroll older-adult participants (>60 years old) clinically diagnosed with MCI or early to moderate AD (n=20 subjects) and 20 dyads of participants (n=40 subjects) composed of an MCI/AD patient and a cognitively normal living partner (> 18 years old ); for a total enrollment of 60 subjects. All participants must have a baseline nightly fasting of \<12 h. Individual participants and dyads will be randomized into the Intervention group (INT) or the Delayed Start Intervention group (DS-INT). The intervention will involve prolonged nightly fasting of 14 hours (TRE). 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. All participants will have study visits, outcome assessments, and biospecimen collections at baseline, 3, and 6 months.
Study Duration: Two years Participant Duration: 6 months
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 60 is close to the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Provision of signed and dated form. Stated willingness to comply with all study procedures and availability for the duration of the study.
Inclusion criteria
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants will follow the time-restricted regimen (14 h of nightly fasting) for 6 months.
Behavioral: Time-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
Also known as: Prolonged Nightly Fasting
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.
Time frame: 3 and 6 months
Effects of TRE on activity rhythms measured as steps/day using an accelerometer
The investigators will measure the participants' 24-hour activity rhythms using an actigraph unit. The investigators will calculate interday stability and intraday variability of activity rhythms, which have been reported as sensitive in studies on aging and AD cohorts. Interday stability will indicate the stability of rhythms across several days. Intraday variability will indicate the fragmentation of rhythms.
Time frame: baseline, 3 and 6 months
Effects of TRE on skin temperature rhythms measured in F using a smart sensor.
The investigators will measure the participants' 24-hour temperature rhythms using a smart sensor. The investigators will calculate interday stability and intraday variability of skin temperature as a circadian output.
Time frame: baseline, 3 and 6 months
Effects of TRE on sleep quantity (as hours/night) using a smart sensor.
The investigators will determine changes in sleep duration during the study as recorded by a smart sensor and accessed via the Fitabase.
Time frame: Baseline, 3 and 6 months
Effects of TRE on sleep quality (determined by a sleep score) using a smart sensor.
The investigators will determine whether the overall sleep efficiency changes based on the sleep score calculated based on metrics collected with the accelerometer watch. The overall sleep score is a sum of the individual scores in sleep duration, sleep quality, and restoration, with a maximum of 100. Sleep score tiers are: Excellent: 90-100; Good: 80-89; Fair: 60-79; Poor: Less than 60.
Time frame: baseline, 3 and 6 months
Explore the effects of TRE on pathology in MCI/AD patients
Evaluate levels of amyloid Beta (AB)40, AB42, phospho-Tau181, Neurofilament light chain protein, and markers of neuroinflammation in plasma
Time frame: baseline, 3 and 6 months
Explore the effects of TRE on markers of epigenetic aging by profiling DNA methylation in blood samples.
The investigators will profile genome-wide DNA methylation in whole blood using the Infinium Methylation EPIC v2.0 array (Illumina) to determine whether prolonged fasting modulates epigenetic aging rates. A beneficial effect will result in no changes to the subjects' biological aging rate or a deacceleration of aging.
Time frame: baseline, 3 and 6 months
Explore the effects of TRE on fasting blood glucose (mg/mL)
The investigators will measure glucose levels in the blood at the end of fasting during the clinical visits to evaluate whether prolonged fasting reduces fasting glucose as an indicator of metabolic health.
Time frame: baseline, 3 and 6 months
Evaluation of neurocognitive changes using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog).
The investigators will utilize the ADAS-Cog test to investigate whether TRE reduces cognitive decline in MCI and AD patients, expressed as the average score changes between visits. The ADAS-Cog is a brief neuropsychological assessment tool used to determine the severity of cognitive symptoms of dementia, widely used in clinical trials assessing antidementia treatments. The ADAS-Cog scores range from 0 to 70, with higher scores indicating poorer performance. It consists of 11 tasks, including Word Recall, Naming Objects and Fingers, Following Commands, Constructional Praxis, Ideational Praxis, Orientation, Word Recognition, Remembering Test Directions, Spoken Language, Comprehension, and Word-Finding Difficulty.
Time frame: baseline and 6 months
Evaluation of changes in self-reported sleep quality as determined by the Pittsburgh Sleep Quality Index (PSQI).
The investigators will utilize the PSQI to investigate whether TRE improves self-reported sleep quality. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the worst dysfunction. The global PSQI score ranges from 0 to 21 and is obtained by adding the scores of the seven components of the test. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.
Time frame: baseline, 3 and 6 months
Plan to share: No — Individual participant data will not be shared
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Apr 2027, 24 months after the start.
Of 54 non-industry phase 1 interventional studies under Cognitive Dysfunction, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 64. This study's planned 24 months is below that.
Counting every sponsor, half of 80 studies reached it within 27 months; a quarter within 13 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
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