VIAging Deceleration Trial Using Metformin, Dasatinib, Rapamycin and Nutritional Supplements

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vitality in Aging Research Group, Inc.
• Treatments: Dasatinib; Metformin; Niacinamide; Quercetin; Resveratrol

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:

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.