Time-restricted eating intervention for Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates whether restricting eating to a 14-hour window at night can reduce cognitive decline and sleep disturbances in patients with Mild Cognitive Impairment (MCI) or early to moderate Alzheimer's disease (AD). The study will assess the feasibility of this time-restricted eating (TRE) approach over a period of 3 to 6 months, comparing outcomes between participants who fast for 14 hours versus those who fast for less than 12 hours. Researchers will evaluate various metabolic and pathological markers to determine the potential benefits of TRE on cognitive function and disease progression.

Why it matters

Who can join: the full rules

Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study.

Inclusion criteria

1. Persons, aged ≥60 years
2. 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.
3. Ability and willingness to complete cognitive evaluations, blood draw, actigraphy monitoring and to record fasting times daily.
4. Daily night fasting \<12h at baseline. Ability and willingness to follow an eating protocol of prolonged night fasting for 14 h
5. For cognitively normal living partners in the dyads group, scores \>26 in the Montreal Cognitive Assessment (MoCA) test administered at screening.

Exclusion Criteria:

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

Where it's running

• Shiley Marcos Alzheimer's Disease Center
  San Diego, California, United States Recruiting

Study contacts

• Principal investigator: Paula Desplats, PhD — University of California, San Diego
• Study coordinator: Paula Desplats, PhD
• Email: pdesplat@health.ucsd.edu
• Phone: 858-534-4839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.