CLINICAL TRIALS

What are
clinical trials?

Clinical trials, or clinical studies, are reserach studies designed to investigate the effect of new therapies or interventions. They are divided into different phases, being each of these phases used to answer a specific set of questions. These studies are carefully designed, reviewed and approved before they start. They also follow strict guidelines to safeguard participants involved, guaranteeing confidentiality and safety. Many of these studies also requires healthy participants, meaning that anyone can take part and help!

The video explains clinical studies in more details (available in Norwegian only)

IMPORTANCE OF CLINICAL TRIALS

1

HELP A CAUSE

Help the development of new and/or better drugs for a specific disease.

2

HELP YOURSELF

Access the newest treatments while having extra medical care at reference research centers. 

3

HELP SCIENCE

Help science to move forward and help on the advance of medical knowlegde. 

ONGOING TRIALS

Our projects aim to improve patient diagnosis and treatment by testing and
developing clinical biomarkers and novel treatments.

NO-PARK

NOPARK will recruit 400 people with PD from all around Norway to investigate whether treatment with nicotinamide riboside (NR) protects nerve cells and delays disease progression. NR increases the level of an essential substance (NAD), which is beneficial for nerve cells’ energy turnover and survival. If the result is positive, the study could lead to new treatment that can slow down Parkinson’s disease. 

N-DOSE

The NADPARK study (completed trial) showed significant biological and clinical effects with 1000 mg NR daily, but higher doses have not been explored in PD. So, it remains unknown whether improved responses can be achieved by escalating the dose. The objective of N-DOSE is to determine the Optimal Biological Dose (OBD) of NR in PD. The outcomes of this project will take us closer to developing NR into a PD-drug.

N-DOSE-AD

The NADPARK study showed significant biological and clinical effects with 1000 mg NR daily, but higher doses have not been explored neither in PD, nor in other neurodegenerative disorders, like Alzheimer’s disease (AD). The objective of N-DOSE-AD is to determine the Optimal Biological Dose (OBD) of NR in AD. The outcomes of this project will take us closer to developing NR into an AD-drug.

STRAT-PARK

STRAT-PARK aims to understand the heterogeneity of PD and identify subgroups of patients with distinct clinical and/or molecular characteristics, so that tailored experimental treatment can be developed and tested. The STRAT-PARK project will recruit PD and healthy people from Bergen, Trondheim and Canada. Healthy individuals are included to compare with patients and distinguish between Parkinson-related variation and naturally occurring variation in the population. 

NAD-BRAIN

NAD-brain is a pharmacokinetic study of NAD replenishment therapy. We will determine the change in blood and brain NAD levels, following the administration of oral NAD replenishment therapy (NRT). Brain NAD levels are measured by phosphorous-MR spectroscopy (31P-MRS). In a first stage, 6 healthy individuals (3 men and 3 women) participated in two 20-day periods. In a second stage, a longer duration of NRT over 4 weeks is examined in 6 healthy individuals and 6 individuals with Parkinson`s disease.

NADAPT

Progressive supranuclear palsy (PSP), Multiple system atrophy (MSA) and corticobasal syndrome (CBS) are severe neurodegenerative diseases that have apparent similarities to Parkinson’s disease (PD), but differ in key symptoms and prevalence. Results from PD studies show that nicotineamide riboside (NR) boost nicotineamide adenine dinucleotide (NAD) levels in the brain. The hypothesis for the NADAPT trial is that oral administration of NR can boost cellular NAD levels in the central nervous system of patients with PSP, MSA and CBS, rectifing metabolism and inhibiting neurodegeneration, which results in delayed disease progression and improvement of symptoms. 

COMPLETED TRIALS

NAD-PARK

The NAD-PARK study aimed to assess the tolerability, cerebral bioavailability and molecular effects of NR therapy in PD. The study showed encouraging results. In summary, NADPARK showed that intake of NR 1000 mg daily was well tolerated and led to a significant, but variable, increase in cerebral NAD levels and related metabolites in the cerebrospinal fluid (CSF). NR recipients showing increased brain NAD levels exhibited altered cerebral metabolism and this was associated with mild clinical improvement. NR augmented the NAD metabolome and induced transcriptional upregulation of processes related to mitochondrial, lysosomal, and proteasomal function in blood cells and/or skeletal muscle. Furthermore, NR decreased the levels of inflammatory cytokines in serum and cerebrospinal fluid. These findings nominate NR as a potential neuroprotective therapy for PD, warranting further investigation in larger trials.

Learn more about NADPARK!

NADPARK was a successful trial and the results of this project attracted attention all over, from scientific highlights to press, and Parkinson’s blogs. The study was selected among the top 10-most influential studies published in Cell Metabolism in 2022!

To learn more about NADPARK, please click below!

NR-SAFE

A phase I, randomized, double-blinded, safety trial of high-dose nicotinamide riboside (NR) in Parkinson’s Disease. This short trial took place during the first half of 2022 and has been completed. Data are currently being analyzed and a open-access publication will be made available shortly.

NR-SAFE studyNature communications paperParkinson’s News Today
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