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VIAging Deceleration Trial Using Metformin, Dasatinib, Rapamycin and Nutritional Supplements
Plain-language guide to NCT04994561: phase 1 interventional trial of NAD+. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04994561
- Phase
- phase 1
- Status
- withdrawn
- Start
- 2022-06
- Completion (planned or actual)
- 2023-12
- Participants
- n/a (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Aging
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around NAD+.
It had 1 arm (groups): 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.
The registry classes the interventions as drug.
Who Took Part
It was open to people of any sex aged from 65 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Male or female subjects 65 years of age or older. HbA1C: \</= 6.4. Vitamin D: \> 30 ng/mL. Homocysteine \< 14 mol/L. B12 levels \>232 pg/mL.
The full record lists 22 inclusion and 14 exclusion criteria; among the exclusions: inability to provide written informed consent; ECOG score \>/= 2; more than 1 alcoholic drinks consumed per day.
How the Study Was Run
Design: single-group and open-label.
Being open-label, the NAD+ study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2022-06 with completion listed for 2023-12.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main 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)). 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)).
What This Means in Plain Language
Put simply, this is a phase 1 trial of NAD+ in people.
It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the NAD+ compound page, all human trials.
Our Notes on the Compound
NAD+: The coenzyme that accepts electrons at complex I.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.