NCT05698771

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2022

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2024

Completed
Last Updated

January 17, 2025

Status Verified

September 1, 2024

Enrollment Period

1.5 years

First QC Date

January 16, 2023

Last Update Submit

January 16, 2025

Conditions

Healthy

Keywords

nicotinamide adenine dinucleotideNADNAD+pharmacokineticsnicotinamide ribosidenicotinamide mononucleotidebrain kinetics

Outcome Measures

Primary Outcomes (1)

  • NAD metabolism

    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.

    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

Secondary Outcomes (2)

  • Interindividual differences

    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

  • Between-sex differences

    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

Study Arms (4)

NR Stage-1 Healthy

EXPERIMENTAL

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.

Dietary Supplement: Nicotinamide Riboside (NR)

NMN Stage-1 Healthy

EXPERIMENTAL

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.

Dietary Supplement: nicotinamide mononucleotide

NR Stage 2 Healthy

EXPERIMENTAL

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).

Dietary Supplement: Nicotinamide Riboside (NR)

NR Stage-2 Parkinson's disease

EXPERIMENTAL

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).

Dietary Supplement: Nicotinamide Riboside (NR)

Interventions

Nicotinamide Riboside (NR)DIETARY_SUPPLEMENT

The NAD-brain study will perform a parallel assessment of NAD replenishment therapy (NRT) pharmacokinetics in the blood and brain of healthy human subjects . A total of 6 healthy individuals (3 men and 3 women) will undergo repeated blood sampling and 31P-MRS brain scans during two 20-day periods, each of which will start with 8 days of daily intake of Nicotinamide Riboside (NR) 600mg x 2, or Nicotinamide Mononucleotide (NMN) 600mg x 2. The two 20-day periods will be 14 days apart to allow for washout of the previous compound. Blood will be analyzed for NAD-metabolites using spectroscopic assays. By this approach we will measure the simultaneous change in NAD-metabolism over time in blood and brain and establish blood and brain pharmacokinetics for NRT in humans.

Also known as: NR Stage-1 Healthy
NR Stage-1 Healthy
nicotinamide mononucleotideDIETARY_SUPPLEMENT

The NAD-brain study will perform a parallel assessment of NAD replenishment therapy (NRT) pharmacokinetics in the blood and brain of healthy human subjects. A total of 6 healthy individuals (3 men and 3 women) will undergo repeated blood sampling and 31P-MRS brain scans during two 20-day periods, each of which will start with 8 days of daily intake of Nicotinamide Riboside (NR) 600mg x 2, or Nicotinamide Mononucleotide (NMN) 600mg x 2. The two 20-day periods will be 14 days apart to allow for washout of the previous compound. Blood will be analyzed for NAD-metabolites using spectroscopic assays. By this approach we will measure the simultaneous change in NAD-metabolism over time in blood and brain and establish blood and brain pharmacokinetics for NRT in humans.

Also known as: NMN Stage-1 Healthy
NMN Stage-1 Healthy

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 30-85 years at the time of enrollment.
  • Neurologically healthy at the time of enrollment.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, Vestland, 5021, Norway

Location

MeSH Terms

Interventions

nicotinamide-beta-ribosideNicotinamide Mononucleotide

Intervention Hierarchy (Ancestors)

RibonucleotidesNucleotidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Charalampos Tzoulis, MD, PhD

    Haukeland University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2023

First Posted

January 26, 2023

Study Start

September 17, 2022

Primary Completion

March 4, 2024

Study Completion

March 4, 2024

Last Updated

January 17, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)