Phase 4
N=72
Clinical Trial of Niagen to Examine Recovery in People With Persistent Cognitive and Physical Symptoms After COVID-19
Covid19 · Sequelae of; Infection · Cognitive Symptom
Bottom Line
View on ClinicalTrials.gov: NCT04809974 ↗Enrolled (actual)
72
Serious AEs
0.8%
Results posted
Jun 2025
Primary outcome: Primary: Effect of Niagen on NAD+ and Cognitive Functioning — -0.104; -0.214; -0.014; -0.147 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Niagen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of Niagen on NAD+ and Cognitive Functioning |
-0.104; -0.214; -0.014; -0.147; -0.222; -0.285 | — |
| SECONDARY Effect of Niagen on NAD+ and Depression Symptoms |
-1.360; 0.167; 0.167; -2.111 | — |
| SECONDARY Effect of Niagen on NAD+ and Anxiety Symptoms |
-0.840; -1.333; -0.167; -1.778 | — |
| SECONDARY Effect of Niagen on NAD+ and Other COVID-related Symptoms |
-3.400; -0.389; 3.444; -4.278 | — |
Summary
The study will assess whether Niagen, a safe dietary supplement, improves recovery of COVID-19 related symptoms in individuals who were infected at least 2 months prior to study entry ("Long-COVID" "Long-haulers"). 60% of participants will receive Niagen and 40% will receive PBO. Outcomes will consist of standardized cognitive, neuropsychiatric, physical, functional and biomarker assessments.
Eligibility Criteria
Inclusion Criteria
- 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;
- At least two neurological and/or physical symptoms that started with COVID-19 infection and are ongoing at study entry, including fatigue, weakness, headache, loss of smell, tingling/numbness, shortness of breath, loss of appetite, palpitations/tachycardia, hair loss, musculoskeletal and/or chest pain;
- Willing and able to consent, complete all assessment and study procedures;
- Not pregnant or lactating.
Exclusion Criteria
- Any specific central nervous system disease history (e.g. major clinical stroke, brain tumor, normal pressure hydrocephalus, etc);
- Clinically significant unstable medical condition that could affect safety or compliance with the study;
- 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;
- History of alcohol or other substance abuse or dependence within the past two years;
- Any significant systemic illness or medical condition that could affect safety or compliance with study;
- Current use of medications with psychoactive properties that may be deleteriously affecting cognition;
- Any known hypersensitivity to nicotinamide riboside, or its principal metabolite, nicotinamide mononucleotide;
- Use of other investigational agents or interventions one month prior to entry and for the duration of the trial;
- If participating in the optional magnetic resonance imaging (MRI) sub-study: Any contraindication to undergo MRI;
- Pregnant women or women who are planning to become pregnant within 7 months from study entry.
Data sourced from ClinicalTrials.gov (NCT04809974). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.