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

Sponsor
Haukeland University Hospital
Study ID
NCT06162013
Phase
PHASE2
Status
Recruiting
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Conditions

  • Corticobasal Syndrome
  • Multiple System Atrophy
  • Progressive Supranuclear Palsy

Eligibility Criteria

Sex
ALL
Age
30 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Nicotinamide Riboside — DIETARY_SUPPLEMENT
    Nicotinamide Riboside 3000mg/day
  • Placebo — OTHER
    Placebo. Identical in taste and appearance as the intervention.

Study Details

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.

Key Dates

First listed
Dec 8, 2023
Start date
Mar 5, 2024
Status verified
Oct 2024
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
330 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Intervention
    Following our basket trial design, there will be three parallel intervention cohorts (one per disease/cohort)
  • Placebo Comparator: Placebo
    Following our basket trial design, there will be three parallel placebo cohorts (one per disease/cohort)

Primary Outcome Measure

PSP Cohort: Between group difference in PSP Rating Scale (PSPRS) total score from baseline to week 78 [ Time Frame: 78 weeks ]

Central Contacts

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