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

NCT04994561 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: VIA-004
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aging

Keywords

Aging; Cell senescence

Outcome Measures

Primary Outcomes (6)

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

  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

  Change from baseline to Visit 20 (approx. Day 502)

• Systolic blood pressure physiological parameter value measured with a blood pressure cuff

  Change from baseline to Visit 20 (approx. Day 502)

• Senescent cell-cycle arrest physiological parameter value measured by MMP-9 laboratory test

  Change from baseline to Visit 20 (approx. Day 502)

• 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)

• DNA Methylation physiological parameter as measured by 2019 GrimAge Clock laboratory test

  Change from baseline to Visit 20 (approx. Day 502)

Study Arms (1)

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.

Drug: Study Drugs and Nutritional Supplements

Interventions

Study Drugs and Nutritional Supplements DRUG

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.

Also known as: metformin, dasatinib, rapamycin and nutritional supplements (bio-quercetin; bio-fisetin; glucosamine; nicotinamide riboside; trans-resveratrol)

Subjects receiving study drugs and nutritional supplements

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vitality in Aging Research Group, Inc.: lead

MeSH Terms

Interventions

Dietary Supplements; Metformin; Dasatinib; Sirolimus; Glucosamine; nicotinamide-beta-riboside; Resveratrol

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Biguanides; Guanidines; Amidines; Organic Chemicals; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Macrolides; Lactones; Hexosamines; Amino Sugars; Carbohydrates; Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polyphenols; Phenols

Study Officials

• Elizabeth Anne Weinstock

  Vitality in Aging

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 6, 2021
• Study Start: June 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share