Actively Recruiting
The NADAPT Study: A Randomized Double-blind Trial of Nicotinamide Riboside Therapy for Atypical Parkinsonism Including PSP, MSA, and CBS
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
Researchers are investigating treatments for three severe neurodegenerative diseases: Progressive Supranuclear Palsy (PSP), Multiple System Atrophy (MSA), and Corticobasal Syndrome (CBS). These diseases progress rapidly, causing worsening motor and cognitive symptoms, with survival ranging from about 3 to 10 years. Currently, no effective therapies exist to slow or stop disease progression, making these conditions a critical challenge for healthcare providers. The NADAPT clinical trial aims to test whether oral nicotinamide riboside (NR) can raise cellular NAD levels in patients' central nervous systems, potentially improving metabolism, reducing neurodegeneration, and slowing disease progression. The NADAPT trial is a phase II, randomized, double-blind study including 130 PSP patients, 165 MSA patients, and an undetermined number of CBS patients. Participants are divided into three disease-specific groups and randomly assigned to receive either 3000 mg of NR daily or a placebo. The study lasts 78 weeks, with both in-clinic visits and remote safety monitoring. After this period, patients may join an open-label extension to continue NR treatment until all participants complete follow-up. During the trial, patients will undergo regular assessments including neurological examinations, patient-reported outcomes, and safety evaluations. Researchers will measure changes in disease severity using rating scales specific to each condition, such as the PSP Rating Scale and Unified MSA Rating Scale, comparing scores from baseline to week 78. The study also monitors cognitive function, mobility, and overall health to evaluate the potential neuroprotective effects of NR. Participants will be followed closely throughout the study to ensure safety and gather comprehensive data on treatment impact.
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
G
Gard Aasmund Skulstad Johanson, MD
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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