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The NO-ALS Study: A Trial of Nicotinamide/Pterostilbene Supplement in ALS.

Plain-language guide to NCT04562831: not phased randomized trial of NAD+, 380 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04562831
Phase
not phased
Status
active, not recruiting
Start
2020-10-07
Completion (planned or actual)
2026-10-31
Participants
380 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
Amyotrophic Lateral Sclerosis
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test NAD+.

Amyotrophic lateral sclerosis (ALS) is a serious rapidly progressive disease of the nervous system.

The average survival from the time of diagnosis is 3 years.

It had two arms (groups): Newly diagnosed ALS patients (experimental) and Earlier diagnosed ALS patients (experimental).

The registry classes the interventions as dietary supplement.

Who Took Part

Enrollment: 380 planned participants were the target.

It was open to people of any sex aged from 35 years with no upper age limit.

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

Examples of who could join: Have a clinical diagnosis of probable ALS according to the revised El Escorial criteria. MR of the brain and cervical spine cannot explain symptoms. Symptom onset no longer than 2 year prior to inclusion. ALS-FRC-R of 36 or more (not any item below 2). Age equal to or greater than 35 years at time of enrollment.

The full record lists 9 inclusion and 7 exclusion criteria; among the exclusions: dementia, ftd or other neurodegenerative disorder at baseline visit; any psychiatric disorder that would interfere with compliance in the study; metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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.

The NAD+ group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on NAD+, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2020-10-07 with completion listed for 2026-10-31.

It ran at 9 sites in Norway (9).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Disease progression as assessed by Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) (time frame: Change from baseline to 1 year).

It also tracked 4 secondary outcomes, for example Change in vital capacity, Change in cognitive functions as assessed by the Edinburgh Cognitive Scale (ECAS), Change of Neurofilament light chain (NFL) levels in serum and Change in quality of life as assessed by the quality of life questionnaire SF-36.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of NAD+ in 380 people.

Its status is active not recruiting; 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.