NAD-brain: a Pharmacokinetic Study of NAD Replenishment Therapy
NCT ID: NCT05698771
Last Updated: 2025-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2022-09-17
2024-03-04
Brief Summary
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Detailed Description
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Moreover, a total of 6 healthy individuals (3 men and 3 women) and 6 individuals with Parkinson's disease (3 men and 3 women) will receive NR 1200 mg daily (600 mg x 2) for 4 weeks, with a total measurement/assessment period of 7 weeks, and undergo repeated blood sampling and 31P-MRS brain scans once per week during this time.
Blood will be analyzed for NAD-metabolites. The simultaneous change in NAD-metabolism over time in blood and brain will be assessed and blood and brain pharmacokinetics for NRT in humans will be established.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
Nicotinamide Riboside (NR)
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.
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.
nicotinamide mononucleotide
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.
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).
Nicotinamide Riboside (NR)
A total of n=6 healthy individuals (3 men and 3 women) will receive NR 1200 mg per day for 4 weeks, followed by 3 weeks of washout. The individuals will undergo repeated blood sampling and 31P-MRS brain scans once per week during the 7 weeks period, Blood will be analyzed for NAD-metabolites using spectroscopic assays.
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).
Nicotinamide Riboside (NR)
A total of n=6 individuals with Parkinson's disease (3 men and 3 women) will receive NR 1200 mg per day for 4 weeks, followed by 3 weeks of washout. The individuals will undergo repeated blood sampling and 31P-MRS brain scans once per week during the 7 weeks period, Blood will be analyzed for NAD-metabolites using spectroscopic assays.
Interventions
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Nicotinamide Riboside (NR)
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.
nicotinamide mononucleotide
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.
Nicotinamide Riboside (NR)
A total of n=6 healthy individuals (3 men and 3 women) will receive NR 1200 mg per day for 4 weeks, followed by 3 weeks of washout. The individuals will undergo repeated blood sampling and 31P-MRS brain scans once per week during the 7 weeks period, Blood will be analyzed for NAD-metabolites using spectroscopic assays.
Nicotinamide Riboside (NR)
A total of n=6 individuals with Parkinson's disease (3 men and 3 women) will receive NR 1200 mg per day for 4 weeks, followed by 3 weeks of washout. The individuals will undergo repeated blood sampling and 31P-MRS brain scans once per week during the 7 weeks period, Blood will be analyzed for NAD-metabolites using spectroscopic assays.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Neurologically healthy at the time of enrollment.
Exclusion Criteria
* 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.
35 Years
85 Years
ALL
Yes
Sponsors
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Haukeland University Hospital
OTHER
Responsible Party
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Principal Investigators
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Charalampos Tzoulis, MD, PhD
Role: STUDY_DIRECTOR
Haukeland University Hospital
Locations
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Haukeland University Hospital
Bergen, Vestland, Norway
Countries
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Other Identifiers
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2023-496197
Identifier Type: -
Identifier Source: org_study_id
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