Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548191
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-20
Brief Title:
TREAD Time Restricted Eating Intervention for Alzheimers Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
TREAD Time Restricted Eating Intervention for Alzheimers Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TREAD
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 Alzheimers 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 6 to 12 months Researchers will compare participants who fast for 14 h per night during 6 months to those who fast for less than 10 hnight Researchers will also compare participants that fast for 6 months to those who fast during 12 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 6 or 12 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
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 6 to 12 months Researchers will compare participants who fast for 14 h per night during 6 months to those who fast for less than 10 hnight Researchers will also compare participants that fast for 6 months to those who fast during 12 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 6 or 12 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
Detailed Description:
Study Description Our overarching hypothesis is that circadian alignment of food intake and biological clocks can reduce pathology and improve cognitive function in Alzheimers 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 6 or 12 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 MCIAD 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 65 years old with normal cognition or with a clinical diagnosis of MCIAD meeting research consensus criteria for probable MCI or dementia due to AD and positive for AD biomarkers
Phase Early phase 1
Description of SitesFacilities Enrolling Participants
Shiley-Marcos Alzheimers 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 65 years old clinically diagnosed with MCI or early to moderate AD n20 subjects and 20 dyads of participants n40 subjects composed of an MCIAD patient and a cognitively normal living partner age-matched for a total enrollment of 60 subjects All participants must have a baseline nightly fasting of 10 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 6 months nightly fasting 10 h followed by 6 months of TRE All participants will have study visits outcome assessments and biospecimen collections at baseline 6 and 12 months
Study Duration Two years Participant Duration 12 months
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 MCIAD 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 65 years old with normal cognition or with a clinical diagnosis of MCIAD meeting research consensus criteria for probable MCI or dementia due to AD and positive for AD biomarkers
Phase Early phase 1
Description of SitesFacilities Enrolling Participants
Shiley-Marcos Alzheimers 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 65 years old clinically diagnosed with MCI or early to moderate AD n20 subjects and 20 dyads of participants n40 subjects composed of an MCIAD patient and a cognitively normal living partner age-matched for a total enrollment of 60 subjects All participants must have a baseline nightly fasting of 10 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 6 months nightly fasting 10 h followed by 6 months of TRE All participants will have study visits outcome assessments and biospecimen collections at baseline 6 and 12 months
Study Duration Two years Participant Duration 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None