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NAD-supplementation in Drug naïve Parkinson's Disease

Plain-language guide to NCT03816020: not phased randomized trial of NAD+, parkinson's disease, 30 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03816020
Phase
not phased
Status
completed
Start
2019-03-09
Completion (planned or actual)
2020-02-10
Participants
30 (actual)
Design
randomized, triple-blind, basic_science
Conditions studied
Parkinson Disease; Neurodegenerative Diseases
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested NAD+ for parkinson's disease.

Primary objective: Determine if NR has an impact on the neurometabolic profile of patients with PD as measured by \[18F\]Fluorodeoxyglucose (FDG)-positron emission tomography (FDG-PET). 2.

It had two arms (groups): NR Group (active comparator) and Placebo Group (placebo comparator).

Participant receiving Placebo BIDfor 30 days.

The registry classes the interventions as dietary supplement and other.

More on the Plan

Only newly diagnosed and drug naïve PD patients are eligible for inclusion.

Participants and investigators will be masked to treatment group.

Participants and investigators will be blinded (double blinded).

Patients will not be using any dopaminergic treatment during the study period.

Who Took Part

30 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Newly diagnosed with PD. Drug naïve with respect to dopaminergic treatment. Have a clinical diagnosis of idiopathic PD according to the MDS clinical diagnostic criteria for PD.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: \[¹²³i\]fp-cit single photon emission ct (datscan) does not show nigrostriatal degeneration; dementia or other neurological disorder at baseline visit; metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit.

How the Study Was Run

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

The parkinson's disease participants were allocated by chance, so the NAD+ group and the comparison group should start out alike.

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

As a double-blind NAD+ study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2019-03-09 with completion listed for 2020-02-10.

It ran at 1 site in Norway.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: PDRP changes from NR use (time frame: 4 weeks).

It also tracked 1 secondary outcome, for example Motoric change of symptoms from NR use.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of NAD+ in 30 people with parkinson's disease.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, Parkinson's disease research.

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.