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

Aging Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04994561
• Other study ID #: VIA-004
• Status: Withdrawn
• Phase: Phase 1
• Start date: June 2022
• Est. completion date: December 2023

Study information

• Verified date: June 2022
• Source: Vitality in Aging Research Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging

Intervention

Drug:
• Study Drugs and Nutritional Supplements
Step 1: 500 mg of metformin and increase their dose 500 mg every 2 weeks up to 2000 mg or until tolerable. Step 2: Once at tolerable daily metformin dose, subjects will take 140 mg of dasatinib along with 58 mg to 174 mg (based on body weight) bio-quercetin and 44.5 mg bio-fisetin. Subjects will take dasatinib, bio-quercetin and bio-fisetin for 2 consecutive days as described 4 times over one year (every 3 months) while participating on this study. Step 3: Two weeks after the first dasatinib dose is complete, subjects will start taking daily nutritional supplements of 1,500 mg glucosamine, 600 mg nicotinamide riboside and 500 mg trans-resveratrol. Step 4: Two weeks after starting daily supplements in Step 3, subjects will take a once weekly 6 mg dose of rapamycin. Once subject is taking rapamycin, they will continue on this intervention for 12 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vitality in Aging Research Group, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0		through study completion, up to post treatment phone (approx. Day 532)
Primary	Visceral adipose tissue fat tissue (volume (in^3)) physiological parameter value measured by DEXA scan		Change from baseline to Visit 20 (approx. Day 502)
Primary	Systolic blood pressure physiological parameter value measured with a blood pressure cuff		Change from baseline to Visit 20 (approx. Day 502)
Primary	Senescent cell-cycle arrest physiological parameter value measured by MMP-9 laboratory test		Change from baseline to Visit 20 (approx. Day 502)
Primary	Glucose control (insulin resistance) physiological parameter as measured by HOMA-IR (mg/dL) calculation value	insulin and glucose laboratory values are collected to computer the measurement used	Change from baseline to Visit 20 (approx. Day 502)
Primary	DNA Methylation physiological parameter as measured by 2019 GrimAge Clock laboratory test		Change from baseline to Visit 20 (approx. Day 502)