Pilot Study to Test the Safety and Efficacy of Metformin, Dasatinib, Rapamycin and Nutritional Supplements (Bio-quercetin; Bio-fisetin; Glucosamine; Nicotinamide Riboside; Trans-resveratrol) in Reducing Clinical Measures of Aging in Older Adults

Vitality in Aging Research Group, Inc.0 个研究点开始时间: 2022年6月最近更新: 2022年6月7日

适应症

干预措施

试验速览

阶段: 1 期
状态: 撤回
发起方
主要终点: Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study aims to assess the safety and efficacy of study drugs and supplements on clinical (structural and functional) signs of aging and to explore/identify other possible biological measures of aging.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 65 Years 至 —（Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Male or female subjects 65 years of age or older
•Received full dose of COVID-19 vaccine
•Fasting Glucose: > 60 - < 125 mg/dl;
•HbA1C: </= 6.4
•Vitamin D: > 30 ng/mL
•Homocysteine < 14 mol/L
•B12 levels >232 pg/mL
•Ferritin: > 30 ng/mL
•Cystatin C: > 0.62 mg/L
•eGFR > 45 mL/min/1.73 m2
•BMI > 18 kg/m2 < 35 kg/m²
•Stable body weight (+/-10 lbs.) over last 6 months
•Be willing to travel to the study facility as required for this study
•Be willing to avoid taking antacids 2 hours prior and 2 hours after taking dasatinib
•Be willing to discontinue proton pump inhibitors
•Be willing to discontinue St. John's Wort
•Be willing to discontinue medication/supplements, if applicable, for a washout period and while participating on this study.
•If taking metformin for anti-aging, willing to washout for 2 months prior to initiating protocol intervention.
•Be willing to take the investigational product(s) according to schedule and keep a diary for compliance monitoring.
•Has not participated in another clinical trial within last 30 days
•If applicable, five years or more post cancer treatment and disease free (define as tumor free or 5 years of clean PET/CT scans).
•Able to provide signed written informed consent prior to any study specific procedures being performed.

排除标准

•Inability to provide written informed consent.
•ECOG score >/= 2
•More than 1 alcoholic drinks consumed per day.
•Anemic (defined as hemoglobin (Hb) levels < 12.0 g/dL in women and < 13.0 g/dL in men)
•Thrombocytopenia (defined as platelet count < 100 × 10^9/L
•Neutropenia (defined as < 1.0-1.5 × 10^9 neutrophils/L (mild))
•Any allergy to any medications or supplements used on this trial.
•Shellfish or iodine allergy (note: glucosamine sulfate supplement contains shellfish (shrimp, crab)
•Clinically significant vital signs (e.g. uncontrolled hypertension >/= 180/100) or lab abnormalities (defined as platelet count < 100 × 10^9/L; absolute granulocyte count < 1,000/mm3; ALT (SGOT) > 2.0 times the upper limit of normal range; total bilirubin > 2.5 times the upper limit of normal range) at baseline
•HIV and/or Hepatitis infection
•Immunosuppressed due to any condition (e.g. transplant).
•Taking concurrent medications that may interfere with the drugs or supplements used on this study.
•Any concurrent uncontrolled medical condition or psychiatric illness which could place the patient at unacceptable risk of study treatment.
•Other concerns that in the PI's judgment will be a potential safety issue for the subject or that precludes the ability to provide informed consent or complete the study.

研究组 & 干预措施

Subjects receiving study drugs and nutritional supplements

Experimental

All eligible and consented subjects will receive study drugs and nutritional supplements as described in the intervention.

干预措施: Study Drugs and Nutritional Supplements (Drug)

结局指标

主要结局

Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0

时间窗: through study completion, up to post treatment phone (approx. Day 532)

Visceral adipose tissue fat tissue (volume (in^3)) physiological parameter value measured by DEXA scan