Clinical Trial of Niagen to Examine Recovery in People With Persistent Cognitive and Physical Symptoms After COVID-19

What Was Tested

In this phase 4 trial, researchers set out to test NAD+.

Outcomes will consist of standardized cognitive, neuropsychiatric, physical, functional and biomarker assessments.

It had two arms (groups): Placebo (placebo comparator) and Niagen (experimental).

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

The registry classes the interventions as drug.

More on the Plan

This study will recruit people who were infected with COVID-19 at least 2 months ago and continue to experience symptoms related to infection.

Variously called "Long-COVID," "COVID long-haulers," or "chronic COVID syndrome", some of the most prominent symptoms are neurologic and neuropsychiatric, including cognitive impairment ('brain fog'), headache, fatigue, muscle aches and weakness, shortness of breath, hair loss and pain, among others.

Participants will complete the following at baseline and every 5 weeks: 1) a standard cognitive battery and subjective cognitive complaints scales; 2) mood measures; 3) assessments of physical functioning, as well as of other common COVID-19-related symptoms; 4) blood draw; and 5) 2 optional MRIs.

Participants will also wear a Fitbit and complete questionnaires to assess sleep and physical activity.

Who Took Part

Enrollment: 72 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: History of SARS-CoV-2 PCR+ at least 2 months prior to study entry;. SARS-CoV-2 negative (PCR) at study entry;. Persistent cognitive difficulties (esp. "brain fog") that began around the time of the acute COVID-19;. Willing and able to consent, complete all assessment and study procedures;. Not pregnant or lactating.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: any specific central nervous system disease history (e.g. major clinical stroke, brain tumor, normal pressure hydrocephalus, etc);; was intubated due to covid-19;; major active or chronic unstable psychiatric illness (e.g. depression, bipolar disorder, obsessive compulsive disorder, schizophrenia) within the previous year;.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this NAD+ study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received NAD+.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2021-08-28 with completion listed for 2023-10-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Effect of Niagen on NAD+ and Cognitive Functioning (time frame: Baseline, Week 10 and Week 20).

It also tracked 3 secondary outcomes, for example Effect of Niagen on NAD+ and Depression Symptoms, Effect of Niagen on NAD+ and Anxiety Symptoms and Effect of Niagen on NAD+ and Other COVID-related Symptoms.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of NAD+ in 72 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the NAD+ compound page, all human trials.