NAD-brain: a Pharmacokinetic Study of NAD Replenishment Therapy

Short name NAD-brain

NCTNCT05698771Other id2023-496197Other id2023

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 12 participants (actual)
Sponsor: Haukeland University Hospital · Other
Design: Not randomized · Open label (no masking)
Countries: 1 country
Norway
Start: 17 Sept 2022
Primary completion: 4 Mar 2024
Completion: 4 Mar 2024
First posted: 26 Jan 2023
Last update posted: 17 Jan 2025
Conditions: Healthy

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2022202320242025

Ph 1
NAD-brain
NCT05698771
17 Sept 2022 to 4 Mar 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The objective of the NAD-brain study is to determine the blood and brain pharmacokinetics of NAD replenishment therapy (NRT) using Nicotinamide Riboside (NR) or Nicotinamide Mononucleotide (NMN).

Interventions

Nicotinamide Riboside (NR)Dietary supplement
nicotinamide mononucleotideDietary supplement
Nicotinamide Riboside (NR)Dietary supplement
Nicotinamide Riboside (NR)Dietary supplement

Arms4

Experimental
NR Stage-1 Healthy
A total of 6 individuals comprising 3 males and 3 females will receive NR 1200 mg daily (600 mg x 2) for 8 days, with a total measurement/assessment period of 20 days. These will be the same individuals as in the NMN-arm. The individuals will enter the two arms sequentially and with a washout period of 14 days.
Experimental
NMN Stage-1 Healthy
A total of 6 individuals comprising 3 males and 3 females will receive NMN 1200 mg daily (600 mg x 2) for 8 days, with a total measurement/assessment period of 20 days. These will be the same individuals as in the NR-arm. The individuals will enter the two arms sequentially and with a washout period of 14 days.
Experimental
NR Stage 2 Healthy
A total of 6 healthy individuals (3 men and 3 women) will receive NR 1200 mg daily (600 mg x 2) for for 4 weeks, followed by 3 weeks of washout (total period of follow-up is 7 weeks).
Experimental
NR Stage-2 Parkinson's disease
A total of 6 with Parkinson's disease (3 men and 3 women) will receive NR 1200 mg daily (600 mg x 2) for for 4 weeks, followed by 3 weeks of washout (total period of follow-up is 7 weeks).

Primary outcomes1

Outcomes the sponsor listed as primary.

NAD metabolism
Time frame · For Stage-1: 20 days for NR and 20 days for NMN comprising 8 days treatment, and 11 days washout. For Stage-2 (NR): 7 weeks comprising 4 weeks of treatment and 3 weeks washout
Registry description
The change of cerebral NAD levels (measured by 31P-MRS) and of blood NAD-metabolites (measured by HPLC-MS), over time (20 days), after the administration of oral NRT with the following NAD precursors: NR 600mg x 2 daily, NMN 600mg x 2 daily.

Secondary outcomes(2)

Interindividual differences
Time frame · For Stage-1: 20 days for NR and 20 days for NMN comprising 8 days treatment, and 11 days washout. For Stage-2 (NR): 7 weeks comprising 4 weeks of treatment and 3 weeks washout
Registry description
Descriptive analyses of interindividual differences in the time course of change in the blood NAD-metabolome and cerebral NAD increase, following the administration of oral NRT.
Between-sex differences
Time frame · For Stage-1: 20 days for NR and 20 days for NMN comprising 8 days treatment, and 11 days washout. For Stage-2 (NR): 7 weeks comprising 4 weeks of treatment and 3 weeks washout
Registry description
Between-sex differences in the time course of change in the blood NAD-metabolome and cerebral NAD increase, following the administration of oral NRT.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 35 Years up to 85 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Age 30-85 years at the time of enrollment. * Neurologically healthy at the time of enrollment. Exclusion Criteria: * History of acute or chronic neurological disorder affecting the central nervous system (CNS). Migraine, cluster headache, and tension headache are allowed, but not on the day of the study visits. * Impaired renal function. * Impaired hepatic function. * Severe hematological disease. * Any psychiatric disorder that would interfere with compliance in the study. * Any severe somatic illness that would make the individual unable to comply and participate in the study. * Mitochondrial disease. * Use of high dose vitamin B3 supplementation within 30 days of enrolment.

PepBank is a research reference. Talk to a doctor before you use any peptide.