Time Restricted Eating in Alzheimer's Disease

The goal of this pilot study on time restricted eating regimens in the mild cognitive impairment (MCI) patient population will be to determine the feasibility of implementing the intervention and impact of time-restricted eating on cognitive performance and biomarkers of metabolic health. Researchers at the Barrow Neurological Institute, Alzheimer's Disease Program in collaboration with the Arizona State University College of Health Solutions will execute the specific aims using a pre-post non-randomized study design in which all participants receive the intervention. Outcome assessments for specific aim 2 will include neuropsychological tests, blood biomarkers, and psychological well-being measured at baseline and after 3 months of intervention.

Participants will be instructed to follow a 16/8 regimen characterized by 16 hours of fasting and an 8-hour eating window daily, on approximately 5 days/week, for 3 months. Primary outcomes will include participant recruitment, retention, acceptability, safety, and adherence to the 16 hours of fasting and 8-hour eating window. Researchers hypothesize that participants who follow a time-restricted eating pattern will have improvements in attention, working memory and semantic fluency domains. Study staff hypothesize that there will be improvements or trends toward improvements in inflammatory and cardiometabolic biomarkers (i.e., interleukin-6, tumor necrosis factor alpha, C-reactive protein, insulin, hemoglobin A1c, and lipids).

The results of this project will provide critical preliminary data for a longer-term, large-scale, randomized controlled trial of time-restricted eating on cognitive trajectory among adults with MCI. The novel findings from the proposed project and future studies will contribute significantly to the body of knowledge that will advance the field, with the ultimate goal of preventing or delaying the progression of MCI to dementia.

Inclusion criteria

• Male or Female outpatients 55-89 years of age.
• Meet Mayo Clinic Criteria for MCI.
• If taking medications that may affect one or more study outcome measures(such as donepezil and memantine),the participant must be on a stable dose for at least the preceding 3 months.
• A body mass index ≥18.5 and <40.0 kg/m2.
• Access to the internet through computer or smartphone.
• Must have a collateral informant/study partner(e.g. spouse or adult child) who has significant direct contact with the patient and who is willing to accompany the patient to specified clinic visits and be available for telephone visits/Interviews.
• An education level > 8 years.
• A proficiency in speaking and reading English or having a family member who is proficient in reading and speaking English and is willing to serve as a translator.
• Vision and hearing must be sufficient to comply with study procedures.

Exclusion criteria

• Diabetes mellitus that requires insulin treatment or is not well managed.
• An eating disorder.
• A contraindication to time-restricted eating.
• Daily eating window <11 hours/day on ≥3 days/week.
• MMSE score ≤9 or patients diagnosed with severe dementia by a clinician.
• In the opinion of the investigator, participation would not be in the best interest of the subject.
• Taking prescription medications twice a day that need to be taken with food.