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NR-SAFE

PHASE I SAFETY AND TOLERABILITY STUDY
OF HIGH-DOSE NICOTINAMIDE RIBOSIDE IN PD

Recruiting: YES
ClinicalTrials.gov ID: NCT05344404
Ethics approval body/ID: REK / 379218
Type of study: phase I, randomized, double-blind safety trial
Single-center: (Haukeland University Hospital)
Participating countries: Norway

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RATIONAL/HYPOTHESIS

It is plausible that the beneficial effects of NR in PD, observed in the NADPARK study, are dose-dependent and more prominent at higher doses. NR doses of up to 2000 mg per day have been tested in healthy humans with no signs of toxicity. However, the safety and tolerability of even higher doses is untested. Here, we will assess the safety and tolerability of an oral dose of 3000 mg NR daily.

INCLUSION CRITERIA

Age equal to or greater than 35 years and lower than 100 years at time of enrollment.

Clinical diagnosis of idiopathic PD according to the MDS criteria1,2.


Hoehn and Yahr score < 4 at enrolment.

EXCLUSION CRITERIA

Dementia or other neurodegenerative disorder at baseline visit.

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.

Use of high dose vitamin B3 supplementation within 30 days of enrollment

Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit.

DESIGN

We are performing a phase I, randomized, double-blind trial. A total of 20 patients with PD will be recruited and randomized (1:1) to either NR 1500mg x 2 daily or placebo. Patients will be followed for 4 weeks with the following measures:

1

Clinical assessment (clinical examination, vital signs, ECG) at baseline and every week

2

Safety blood parameters at baseline, days 3, 5, 7, and then every week

3

Screening for adverse events at baseline, days 3, 7, and then every week

4

Blood and urine for metabolomics collected at baseline and day 28

OBJECTIVES



PRIMARY OBJECTIVES:

To determine the safety of oral NR dose of 3000mg daily for a period of 4 weeks in individuals with Parkinson’s disease (PD). Safety is defined as:

1

The absence of moderate or severe, acute or subacute adverse effects associated with an oral NR dose of 3000mg daily.

2

No significant change in clinical laboratory values associated with an oral NR dose of 3000mg daily.

3

No significant change in vital parameters associated with an oral NR dose of 3000mg daily.

SECONDARY OBJECTIVES:
Assess the following in relation to an oral NR dose of 3000mg daily:

1

Tolerability defined as self-reported mild adverse effects by subjects.

2

Changes in the NAD metabolome and related metabolites

OUTCOMES

PRIMARY OUTCOME Between-group (NR vs. placebo) difference in
1. Reported moderate/severe acute and subacute adverse effects at the end of study
2. Safety laboratory values: CRP, ALAT, ASAT, GT, bilirubin, ALP, creatinine, urea, RBC, Hb, WBC with differential, platelets, CK, FT4, TSH, B12, folic acid, homocysteine, methylmalonic acid, sodium, potassium, calcium, fasting glucose, insulin)
3. Vital parameters: (Blood pressure, pulse, EKG).

SECONDARY OUTCOME
1. Self-reported mild adverse effects after 4 weeks of follow up.
2. NAD metabolome in whole blood/PBMC measured by mass spectrometry (LC-MS/MS Q-Exactive HF).

START DATE

29th April 2022

END DATE

1st July 2022

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