Actively Recruiting
The NADAPT Study: a Randomized Double-blind Trial of NAD Replenishment Therapy for Atypical Parkinsonism
Led by Haukeland University Hospital · Updated on 2025-01-10
330
Participants Needed
3
Research Sites
247 weeks
Total Duration
On this page
Sponsors
H
Haukeland University Hospital
Lead Sponsor
O
Oslo University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The NADAPT Study: a Randomized Double-blind Trial of NAD Replenishment Therapy for Atypical Parkinsonism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understands the study and can provide written informed consent
- Male or female aged 30 to 85 years at baseline
- Has had a 123I-Ioflupane dopamine transporter scan (DaTSCAN) or FDOPA-PET performed, with a negative DaTSCAN no older than two years at baseline
- Meets MDS criteria for possible or probable PSP, or
- Meets MDS criteria for clinically possible or probable MSA, or
- Meets consensus criteria for probable or possible CBS
- Baseline PSP Rating Scale score less than 40 for PSP, or baseline Unified MSA Rating Scale items 1, 2, and 7-9 score less than 3
- Mini-Mental State Examination score of 20 or higher at screening
- Able to walk independently or with assistance by taking at least five steps with a walker or with help from another person who contacts only one upper limb
You will not qualify if you...
- Insufficient fluency in the local language to complete assessments
- Evidence of other diagnoses such as Parkinson's disease, dementia with Lewy bodies, Alzheimer's disease, motor neuron disease, stroke, brain or spinal cord injury, long-term neuroleptic use (except quetiapine), severe encephalitis, drug-related parkinsonism, vascular parkinsonism, familial PSP, frontotemporal dementia, or prion disease
- Other neurological or psychiatric disorders including psychosis, severe mood disorders, seizures, tumors, or space-occupying lesions
- Use of nicotinamide riboside or investigational drugs/devices within 90 days before screening
- History of alcohol or substance abuse within one year prior to baseline deemed clinically significant
- Active cancer (except non-metastatic skin conditions) within two years of screening or unstable significant medical conditions
- Clinically significant lab abnormalities incompatible with study participation
- History of deep brain stimulator surgery other than sham surgery in a clinical trial
- Medical conditions interfering with study compliance, increasing risk, or confounding results
- Severe swallowing difficulties preventing safe intake of study drug at baseline
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Oslo University Hospital
Oslo, Oslo, Norway, 0424
Actively Recruiting
2
Haukeland University Hospital
Bergen, Vestland, Norway, 5021
Actively Recruiting
3
Vestre Viken HF
Drammen, Norway
Actively Recruiting
Research Team
G
Geir Olve Skeie, MD, Dr.med
CONTACT
G
Gard Aasmund Skulstad Johanson, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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