What is the mechanism of action of this treatment?

Common treatments for aging, such as Nicotinamide Riboside (NR), work by enhancing cellular energy metabolism and combating cellular aging. NR, a form of Vitamin B3, increases levels of NAD+ (nicotinamide adenine dinucleotide), a coenzyme essential for energy production and metabolic processes. Higher NAD+ levels improve mitochondrial function, reduce oxidative stress, and promote DNA repair, which are crucial for maintaining cellular health. For aging patients, these mechanisms can slow the aging process, improve cognitive function, and enhance overall vitality.

What side effects are associated with this type of intervention?

Common treatments aimed at enhancing cellular energy metabolism and combating cellular aging, such as Nicotinamide Riboside (NR), generally have mild side effects. These can include nausea, fatigue, headaches, and gastrointestinal discomfort. More severe side effects are rare but may include liver enzyme abnormalities and potential interactions with other medications. It is important to consult with a healthcare provider to tailor treatments to individual health needs and monitor for any adverse effects.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved drugs explicitly for the treatment of aging. However, Nicotinamide Riboside (NR), a form of Vitamin B3, is being studied for its potential to improve cellular energy metabolism and combat cellular aging. While NR itself is not FDA-approved for aging, it represents a class of compounds aimed at enhancing cellular health and longevity. Other related compounds and interventions, such as those targeting mitochondrial function and oxidative stress, are also under investigation but have not yet received FDA approval specifically for aging.

What other types of research exist?

Promising alternatives to Nicotinamide Riboside for aging patients include: 1) Metformin, which has shown potential in extending lifespan and improving metabolic health; 2) Rapamycin, known for its effects on mTOR signaling and longevity; 3) Senolytics, which target and eliminate senescent cells to improve tissue function; 4) NAD+ precursors like Nicotinamide Mononucleotide (NMN), which also boost NAD+ levels and cellular energy metabolism.

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Vitamin B3 Supplement

NAD Supplementation for Brain Health in Aging

Phase 4

Recruiting

Led By Andriy Yabluchanskiy, MD, PhD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥60 and ≤85 years of age

Adequate hearing and visual acuity to participate in the examinations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial tests if taking Nicotinamide Riboside (NR), a form of Vitamin B3, can improve brain health and memory in older adults aged 60-85 by boosting a molecule called NAD that helps with energy and cell health. Nicotinamide Riboside (NR) is a precursor to NAD+, which has been identified as a promising treatment strategy for age-related cognitive decline and other conditions.

Who is the study for?

This trial is for people aged 60 to 85 who can read and write in English, have good enough vision and hearing to participate, and can give informed consent. It's not for those with recent severe strokes, major uncontrolled psychiatric conditions, substance abuse issues, active brain diseases or poor kidney function.

What is being tested?

The study tests if Nicotinamide Riboside (NR), a form of Vitamin B3, improves brain health and memory in older adults. Participants will take NR daily or a placebo without knowing which one they're getting to compare the effects fairly.

What are the potential side effects?

While the side effects are not detailed here, as NR is a vitamin supplement generally considered safe at recommended doses, potential side effects could include mild digestive upset or skin flushing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 60 and 85 years old.

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I can see and hear well enough to undergo tests.

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I understand and can agree to the study's procedures and risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in neuronal activity

Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS)

Change in neurovascular coupling using the dynamic retinal vessel analysis

+1 more

Secondary study objectives

Blood collection

Change in Attention

Change in ECG

+12 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NRExperimental Treatment1 Intervention

Treatment with oral NR (1g/day per os for 8 weeks)

Group II: ControlPlacebo Group1 Intervention

Visually identical placebo (daily, per os, for 8 weeks)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nicotinamide riboside

2021

Completed Phase 3

~390

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for aging, such as Nicotinamide Riboside (NR), work by enhancing cellular energy metabolism and combating cellular aging. NR, a form of Vitamin B3, increases levels of NAD+ (nicotinamide adenine dinucleotide), a coenzyme essential for energy production and metabolic processes. Higher NAD+ levels improve mitochondrial function, reduce oxidative stress, and promote DNA repair, which are crucial for maintaining cellular health. For aging patients, these mechanisms can slow the aging process, improve cognitive function, and enhance overall vitality.