TREAD: Time Restricted Eating Intervention for Alzheimer's Disease
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Feasibility: assessed by computing the number of nights achieving the goal fasting time of 14 h.
研究概览
简要总结
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
详细描述
Study Description: Our overarching hypothesis is that circadian alignment of food intake and biological clocks can reduce pathology and improve cognitive function in Alzheimer's 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 3 or 6 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 MCI/AD patients.
Endpoints:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Blinding disease condition and arm
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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 brain or cerebrospinal fluid (CSF) obtained at their regular point of care or study referral no longer than 3 months prior to screening.
- •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.
排除标准
- •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) <
研究组 & 干预措施
Delayed-Start Intervention
Participants will continue their regular eating schedule (nightly fasting for less than 12 h) during the first 3 months and start time-restricted eating intervention ( 14 h of nightly fasting) for the next 3 months.
干预措施: Time-restricted eating (Behavioral)
Intervention
Participants will follow the time-restricted regimen (14 h of nightly fasting) for 6 months.
干预措施: Time-restricted eating (Behavioral)
结局指标
主要结局
Feasibility: assessed by computing the number of nights achieving the goal fasting time of 14 h.
时间窗: 3 and 6 months
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.
次要结局
- Effects of TRE on activity rhythms measured as steps/day using an accelerometer(baseline, 3 and 6 months)
- Effects of TRE on skin temperature rhythms measured in F using a smart sensor.(baseline, 3 and 6 months)
- Effects of TRE on sleep quantity (as hours/night) using a smart sensor.(Baseline, 3 and 6 months)
- Effects of TRE on sleep quality (determined by a sleep score) using a smart sensor.(baseline, 3 and 6 months)
- Explore the effects of TRE on pathology in MCI/AD patients(baseline, 3 and 6 months)
- Explore the effects of TRE on markers of epigenetic aging by profiling DNA methylation in blood samples.(baseline, 3 and 6 months)
- Explore the effects of TRE on fasting blood glucose (mg/mL)(baseline, 3 and 6 months)
- Evaluation of neurocognitive changes using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog).(baseline and 6 months)
- Evaluation of changes in self-reported sleep quality as determined by the Pittsburgh Sleep Quality Index (PSQI).(baseline, 3 and 6 months)
研究者
Paula Desplats
Associate Professor of Neuroscience
University of California, San Diego