AgingPhase 1NCT04994561
VIAging Deceleration Trial Using Metformin, Dasatinib, Rapamycin and Nutritional Supplements
A Phase 1 study testing Study Drugs and Nutritional Supplements in people with Aging, run by Vitality in Aging Research Group, Inc..
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Study Drugs and Nutritional Supplements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Show all 22Show fewer
- 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.
Who cannot join
- 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))
Show all 14Show fewer
- 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.
About this study
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
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
- Being tested
- Study Drugs and Nutritional Supplements
- Keywords
- Aging, Cell senescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Drugs and Nutritional SupplementsDrug
Also called metformin, dasatinib, rapamycin and nutritional supplements (bio-quercetin; bio-fisetin; glucosamine; nicotinamide riboside; trans-resveratrol)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Study Drugs and Nutritional Supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0
Measured: 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
Measured: Change from baseline to Visit 20 (approx. Day 502)
Systolic blood pressure physiological parameter value measured with a blood pressure cuff
Measured: Change from baseline to Visit 20 (approx. Day 502)
Senescent cell-cycle arrest physiological parameter value measured by MMP-9 laboratory test
Measured: 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
Measured: Change from baseline to Visit 20 (approx. Day 502)
DNA Methylation physiological parameter as measured by 2019 GrimAge Clock laboratory test
Measured: Change from baseline to Visit 20 (approx. Day 502)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study startJun 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Study was withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitality in Aging Research Group, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Anne Weinstock, Study director, Vitality in Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994561
- Sponsor's protocol ID
- VIA-004
- Status last verified
- Jun 2022
- First submitted
- 23 Jul 2021
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04994561
- Acronym / sponsor ID
- VIA-004
- Conditions
- Aging
- Keywords
- Aging, Cell senescence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vitality in Aging Research Group, Inc.University, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving study drugs and nutritional supplements | Experimental | Drug: Study Drugs and Nutritional SupplementsAll eligible and consented subjects will receive study drugs and nutritional supplements as described in the intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study Drugs and Nutritional SupplementsAlso: metformin, dasatinib, rapamycin and nutritional supplements (bio-quercetin; bio-fisetin; glucosamine; nicotinamide riboside; trans-resveratrol)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. | Drug | Subjects receiving study drugs and nutritional supplements |
Primary outcome
Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0
Time frame: 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
Time frame: Change from baseline to Visit 20 (approx. Day 502)
Systolic blood pressure physiological parameter value measured with a blood pressure cuff
Time frame: Change from baseline to Visit 20 (approx. Day 502)
Senescent cell-cycle arrest physiological parameter value measured by MMP-9 laboratory test
Time frame: Change from baseline to Visit 20 (approx. Day 502)
Glucose control (insulin resistance) physiological parameter as measured by HOMA-IR (mg/dL) calculation value
Time frame: Change from baseline to Visit 20 (approx. Day 502)
insulin and glucose laboratory values are collected to computer the measurement used
DNA Methylation physiological parameter as measured by 2019 GrimAge Clock laboratory test
Time frame: Change from baseline to Visit 20 (approx. Day 502)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Aging
Enrolling by invitationPhase 2
Tirzepatide and Organ-specific Biological Aging
Longevity, Preventive Medicine
Active, not recruiting
Emotional Well-being and Measures of Healthy Aging
Aging, Aging, Healthy
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Active, not recruiting
Vascular Aging and Lp299v Study in Healthy Adults
Vascular Aging
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Anne Weinstock study director
Vitality in Aging
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Study Drugs and Nutritional Supplements in people with Aging, run by Vitality in Aging Research Group, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0 (time frame: through study completion, up to post treatment phone (approx. Day 532)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.