What is the mechanism of action of this treatment?

Common treatments for cognitive symptoms, such as Nicotinamide Riboside (NR), work by increasing levels of NAD+, a molecule essential for cellular energy metabolism and mitochondrial function. NAD+ supports the repair of damaged DNA, enhances mitochondrial efficiency, and reduces oxidative stress. These actions are crucial for maintaining neuronal health and function, which can help improve cognitive performance and protect against neurodegenerative processes. For patients with cognitive symptoms, these treatments offer a potential means to enhance brain health and mitigate cognitive decline.

What side effects are associated with this type of intervention?

Common treatments for cognitive symptoms, such as Niagen (Nicotinamide Riboside), which supports cellular energy metabolism and mitochondrial function, generally have a favorable safety profile. However, some side effects have been reported. For instance, high-dose B vitamin supplements have been associated with an increased incidence of depression. Acetyl-l-carnitine, another supplement studied for cognitive benefits, has been linked to nausea and vomiting in some patients. It is important for patients to discuss these potential side effects with their healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of cognitive symptoms, particularly in conditions like Alzheimer's disease. These include cholinesterase inhibitors (e.g., donepezil, rivastigmine, and galantamine) and NMDA receptor antagonists (e.g., memantine). While these drugs focus on neurotransmitter modulation, Niagen (Nicotinamide Riboside) is being studied for its potential to support cellular energy metabolism and mitochondrial function, which represents a different approach to cognitive health. There are no specific FDA approvals for Niagen or similar NAD+ precursors for cognitive symptoms as of now.

What other types of research exist?

Promising alternatives to Niagen for cognitive symptoms include: 1) Patisiran, which has shown efficacy in reducing neuropathy symptoms and improving quality of life in patients with ATTRm amyloidosis, potentially benefiting cognitive function. 2) Inotersen, another treatment for ATTRm amyloidosis, which also improves quality of life and may have neuroprotective effects. 3) A vitamin/nutriceutical formulation containing folate, vitamin B12, alpha-tocopherol, S-adenosyl methionine, N-acetyl cysteine, and acetyl-L-carnitine, which has shown efficacy in Alzheimer's disease. These alternatives should be discussed with a healthcare provider to determine the best option based on individual patient needs and conditions.

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Dietary Supplement

Niagen for Post-COVID Syndrome

Phase 4

Waitlist Available

Led By Edmarie Guzman-Velez, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 and 22 weeks

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial tests Niagen, a Vitamin B3 supplement, on people with long-term COVID-19 symptoms. It aims to see if the supplement can improve thinking skills, mood, and physical health by boosting cell energy and brain function.

Who is the study for?

This trial is for individuals who have had COVID-19 and are experiencing ongoing neurological or physical symptoms like fatigue, headaches, or 'brain fog' at least two months after infection. Participants must not be pregnant, lactating, or have a history of hypersensitivity to nicotinamide riboside. They should not be using psychoactive medications that affect cognition and must not have any major psychiatric illness within the last year.

What is being tested?

The study tests Niagen, a dietary supplement, to see if it helps people with Long-COVID recover from persistent cognitive and physical symptoms. Sixty percent of participants will receive Niagen while forty percent will get a placebo (PBO). The effects will be measured through various assessments including cognitive tests and biomarkers.

What are the potential side effects?

While the description does not list specific side effects for Niagen in this context, as a dietary supplement it may cause mild issues such as nausea or indigestion. However, since it's being tested in Long-COVID patients here, monitoring for unexpected reactions is part of the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 and 22 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 and 22 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 and 22 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

Cognition

Secondary study objectives

Examine the effect of Niagen in COVID-related physical symptoms

Examine the effect of Niagen in anxiety symptoms

Examine the effect of Niagen in depression symptoms

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: NiagenExperimental Treatment1 Intervention

Supplement: 60 participants will take Niagen 2000mg in the form of capsules daily.

Group II: PlaceboPlacebo Group1 Intervention

Placebo: 40 participants will take placebo in the form of a capsule.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nicotinamide riboside

Not yet FDA approved

Do I qualify?Apply below to find out

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 cognitive symptoms, such as Nicotinamide Riboside (NR), work by increasing levels of NAD+, a molecule essential for cellular energy metabolism and mitochondrial function. NAD+ supports the repair of damaged DNA, enhances mitochondrial efficiency, and reduces oxidative stress. These actions are crucial for maintaining neuronal health and function, which can help improve cognitive performance and protect against neurodegenerative processes. For patients with cognitive symptoms, these treatments offer a potential means to enhance brain health and mitigate cognitive decline.

Protective Effects of Nicotinamide Adenine Dinucleotide and Related Precursors in Alzheimer's Disease: A Systematic Review of Preclinical Studies.