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NCT06548191 · ClinicalTrials.gov registry record · Phase 1
TREAD: Time Restricted Eating Intervention for Alzheimer's Disease
A Phase 1 study of Alzheimer Disease and Mild Cognitive Impairment, sponsored by University of California, San Diego.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06548191: Recruiting Phase 1 study of Alzheimer Disease and Mild Cognitive Impairment, sponsored by University of California, San Diego.
NCT06548191 is a Phase 1 study of Alzheimer Disease and Mild Cognitive Impairment that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 60 participants, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06548191, a Phase 1 study of Alzheimer Disease and Mild Cognitive Impairment, is actively recruiting participants, sponsored by University of California, San Diego.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL Time-restricted eating
Study Locations (1)
California
- Shiley Marcos Alzheimer's Disease Center - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-04-23 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What NCT06548191 shows while recruiting
NCT06548191 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 1 intervention - of which Time-restricted eating is the first listed.
NCT06548191 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06548191 about?
NCT06548191 is a clinical study titled "TREAD: Time Restricted Eating Intervention for Alzheimer's Disease". 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 l...
What is the current status of trial NCT06548191?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2025-04-23. Estimated completion is 2026-12-31.
What conditions does trial NCT06548191 study?
This clinical trial studies the following conditions: Alzheimer Disease, Mild Cognitive Impairment, Alzheimers Disease.
What interventions are being tested in trial NCT06548191?
The interventions under investigation include: Time-restricted eating (BEHAVIORAL).
Who is sponsoring clinical trial NCT06548191?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06548191 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06548191's enrollment target sits among peer trials
60 187th of 306 higher than 108 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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