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New treatment option for Mild Cognitive Impairment
Official title TREAD: Time Restricted Eating Intervention for Alzheimer's Disease
ClinicalTrials.gov ID: NCT06548191
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 6 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older. Healthy volunteers may be eligible.
You may be able to join if
- Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the...
- 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...
- 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
You likely can't join 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.
See the full eligibility criteria
- Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study.
- 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...
- 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.
- 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) \ 35
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.