Clinical trial NCT04994561: VIAging Deceleration Trial Using Metformin, Dasatinib, Rapamycin and Nutritional Supplements
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Aging
Keywords: Aging
Cell senescence
Lead sponsor: Vitality in Aging Research Group, Inc.
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Inability to provide written informed consent.
2. ECOG score \>/= 2
3. More than 1 alcoholic drinks consumed per day.
4. Anemic (defined as hemoglobin (Hb) levels \< 12.0 g/dL in women and \< 13.0 g/dL in men)
5. Thrombocytopenia (defined as platelet count \< 100 × 10\^9/L
6. Neutropenia (defined as \< 1.0-1.5 × 10\^9 neutrophils/L (mild))
7. Any allergy to any medications or supplements used on this trial.
8. Shellfish or iodine allergy (note: glucosamine sulfate supplement contains shellfish (shrimp, crab)
9. 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
10. HIV and/or Hepatitis infection
11. Immunosuppressed due to any condition (e.g. transplant).
12. Taking concurrent medications that may interfere with the drugs or supplements used on this study.
13. Any concurrent uncontrolled medical condition or psychiatric illness which could place the patient at unacceptable risk of study treatment.
14. 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.

Primary outcomes:
measure: Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0
timeFrame: through study completion, up to post treatment phone (approx. Day 532)
measure: Visceral adipose tissue fat tissue (volume (in^3)) physiological parameter value measured by DEXA scan
timeFrame: Change from baseline to Visit 20 (approx. Day 502)
measure: Systolic blood pressure physiological parameter value measured with a blood pressure cuff
timeFrame: Change from baseline to Visit 20 (approx. Day 502)
measure: Senescent cell-cycle arrest physiological parameter value measured by MMP-9 laboratory test
timeFrame: Change from baseline to Visit 20 (approx. Day 502)
measure: Glucose control (insulin resistance) physiological parameter as measured by HOMA-IR (mg/dL) calculation value
timeFrame: Change from baseline to Visit 20 (approx. Day 502)
measure: DNA Methylation physiological parameter as measured by 2019 GrimAge Clock laboratory test
timeFrame: Change from baseline to Visit 20 (approx. Day 502)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vitality in Aging
name: Elizabeth Anne Weinstock
role: STUDY_DIRECTOR
References: