The NADAPT Study: a Randomized Double-blind Trial of NAD Replenishment Therapy for Atypical Parkinsonism

Summary

Progressive supranuclear palsy (PSP), Multiple system atrophy (MSA) and corticobasal syndrome (CBS) are severe neurodegenerative diseases with rapid progression and no effective treatment. Patients quickly succumb to increasing motor and non-motor symptoms and survival ranges from \~3 years to \~10 years.

Although PSP, MSA and CBS are rare diseases they constitute a major and mostly unaddressed challenge to health-care providers due to the severity of disease and lack of treatment.

The main 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, and rectify metabolism and inhibit neurodegeneration, resulting in delayed disease progression and amelioration of symptoms for these patients.

To test whether NR is a neuroprotective therapy for atypical parkinsonism, the investigators will perform the NADAPT clinical trial. The investigators will include 130 patients with Progressive supranuclear palsy (PSP), 165 patients with Multiple system atrophy (MSA) and an indeterminate number of patients with corticobasal syndrome (CBS). The participants will be stratified by disease into three cohorts and randomized to either 3000mg NR daily or placebo.

The trial will include patients from all of Norway. Patients will be followed for 78 weeks with both in-clinic visits and decentralized safety measurements and reporting of patient reported outcomes (PROMs). After completion of the 78 weeks follow-up, patients are offered to continue in an open-label NR-only extension study, this extension study will last until follow-up is completed for the last patients in NADAPT.

Conditions

• Progressive Supranuclear Palsy
• Multiple System Atrophy
• Corticobasal Syndrome

Interventions

DIETARY_SUPPLEMENT

Nicotinamide Riboside

Nicotinamide Riboside 3000mg/day

OTHER

Placebo

Placebo. Identical in taste and appearance as the intervention.

Sponsors & Collaborators

• Oslo University Hospital

  collaborator OTHER

• Akershus Universitetssykehus HF

  collaborator UNKNOWN

• Vestre Viken Hospital Trust

  collaborator OTHER

• Sykehuset Ostfold

  collaborator OTHER

• Nevro Arendal AS

  collaborator UNKNOWN

• Helse Forde

  collaborator OTHER

• Helse Fonna

  collaborator OTHER

• Universitetssykehuset Nord Norge HF

  collaborator UNKNOWN

• Helse Møre og Romsdal HF

  collaborator OTHER_GOV

• Nordlandssykehuset HF

  collaborator OTHER

• Elysium Health

  collaborator INDUSTRY

• Haukeland University Hospital

  lead OTHER

Principal Investigators

• Charalampos Tzoulis, MD, PhD · Haukeland University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-05

Primary Completion

2028-12-31

Completion

2028-12-31

Countries

• Norway

Study Locations