ClinicalTrials.gov record NCT06162013

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 7, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Age30 years old to 85 years old
SexAll
LocationNorway
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase II randomized, double-blind trial compares oral nicotinamide riboside (NR) 3,000 mg/day with placebo in three groups: PSP, MSA, and CBS. The study plans 130 PSP and 165 MSA participants, plus an undetermined number with CBS; participants are randomized 1:1 within each disease cohort and followed for 78 weeks with clinic visits, remote safety checks, and patient-reported outcome measures. After 78 weeks, participants are offered an open-label NR-only extension.

What it is studying. The study is testing whether daily oral nicotinamide riboside (3,000 mg) changes clinical progression and symptoms in PSP, MSA, and CBS. Investigators hypothesize NR can raise brain NAD levels and affect metabolism and neurodegeneration; the trial compares NR with placebo over 78 weeks.

What the researchers hope to learn. To measure whether NR changes clinical rating scores at 78 weeks (PSPRS for PSP and CBS; UMSARS for MSA), to assess safety and tolerability, and to evaluate imaging and patient-reported outcomes.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Dietary supplement
  • Nicotinamide Riboside
Other
  • Placebo

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Participant must understand the nature of the study and be able to provide written, informed consent.
  • Male or female aged 30-85 years at baseline.
  • 123I-Ioflupane dopamine transporter imaging (DaTSCAN) or FDOPA- PET has been performed. A negative DaTSCAN cannot be more than two years old at baseline.
  • Meet the MDS criteria for possible or probable PSP; or
  • Meet the MDS criteria for clinically possible or probable MSA; or
  • Meet the consensus criteria for probable or possible CBS.
  • A baseline PSPRS score of <40 for PSP, or baseline UMSARS score < 3 on items: 1, 2, 7-9.
  • Score ≥ 20 on the Mini-Mental State Examination (MMSE) at screening.
  • Able to ambulate independently or with assistance defined as the ability to take at least 5 steps with a walker (guarding is allowed provided there is no contact) or the ability to take at least 5 steps with the assistance of another person who can only have contact with one upper extremity.

Exclusion criteria

  • Insufficient fluency in local language to complete neuropsychological and functional assessments.
  • Evidence of differential diagnoses to PSP, MSA or CBS including: PD; dementia with Lewy bodies; Alzheimer's disease; motor neuron disease; history of repeated and/or major stroke; history of repeated and/or severe brain or spinal cord; history of neuroleptic use (except quetiapine) for prolonged period within the last 6 months; history of severe encephalitis; street drug-related parkinsonism; vascular parkinsonism; familial PSP, FTD, or known pathogenic MAPT mutation; prion disease; other neurological disease or MRI findings that could explain the PSP, MSA or CBS symptoms.
  • Presence of other significant neurological or psychiatric disorders including (but not limited to) psychotic disorders; severe bipolar or unipolar depression; seizure disorder; tumor or other space-occupying lesion.
  • Treatment with/use of NR or any investigational drugs or device, within 90 days of screening.
  • A history of alcohol or substance abuse within 1 year prior to baseline (Visit 1) and deemed to be clinically significant by the site investigator
  • Any active neoplastic malignancy (other than non-metastatic dermatological conditions) within two years of the screening visit (Visit 0) or current clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disease. Active neoplastic malignancy is defined as having a known malignant focus and/or receiving anti-cancer treatment. For the non-cancer conditions, if the condition has been stable for at least the one year before the screening visit (Visit 0) and/or is judged by the site investigator not to interfere with the subject's participation in the study, the subject may be included.
  • Clinically significant laboratory abnormalities at screening that cannot be corrected to baseline and that is deemed incompatible with study participation by investigator.
  • History of deep brain stimulator surgery other than sham surgery for deep brain stimulation (DBS) clinical trial.
  • History of a clinically significant medical condition that would interfere with the subject's ability to comply with study instructions, would place the subject at increased risk, or might confound the interpretation of the study results.
  • Severe dysphagia with inability to swallow study-drug safely at baseline.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Background/Rationale: Atypical parkinsonian syndromes (APS) are rapidly progressive, debilitating, and incurable neurodegenerative diseases, including progressive supranuclear palsy (PSP), multiple system atrophy (MSA) and corticobasal syndrome (CBS). These are classified as rare and orphan disorders according to EU regulation, with a reported prevalence of 7/100,000 for PSP, 4.4/100,000 for MSA, and 0.6-1/100,000 for CBS, although accurate numbers for CBS are lacking. Currently, there are no neuroprotective therapies able to delay the progression of APS. Moreover, unlike Parkinson's disease (PD), symptomatic therapy is largely ineffective. Without options for disease modification or symptom relief, patients succumb to rapidly increasing motor and cognitive disability, and become quickly care-dependent, with an estimated overall survival from diagnosis between 3-8 years for PSP, 6-10 years for MSA and ~7 years for CBS. Despite being a source of morbidity and mortality comparable to amyotrophic lateral sclerosis (ALS), there are currently no clinical treatment studies on PSP, MSA, or CBS in Norway, and very few initiatives globally. Given the complete lack of therapy - neuroprotective, symptomatic or palliative - these disorders constitute an important and urgent challenge to health care and society. Taken together, the findings of our NAD-replenishment trials, NADPARK (NCT03816020) and NR-SAFE (NCT05344404), provide robust experimental evidence that: 1) NR has a dose-dependent symptomatic antiparkinsonistic effect, which occurs on the top of optimal dopaminergic therapy; 2) Nominate NR as a potential neuroprotective therapy for parkinsonism, able to ameliorate cerebral metabolism and dampen neuroinflammation. Encouraged by these findings, the investigators proposed that NAD-replenishment therapy via oral NR intake could show promise as both symptomatic and neuroprotective therapy for APS. Given the complete lack of treatment options for individuals with PSP, this trial is both timely and necessary. The investigators will conduct the NADAPT trial, a randomized, double blinded, phase II trial testing the efficacy of NAD replenishment therapy with nicotinamide riboside (NR) as a disease modifying therapy for APS. 130 patients with PSP, 165 patients with MSA, and an undetermined number of patients with CBS will be stratified by disease and randomized 1:1 per disease to receive either 3000mg NR a day or placebo (Fig 1). Follow up will be 18 months and consist of both in-clinic visits and decentralized patient-reported outcomes. NADAPT follows a basket trial design, essentially encompassing three trials in one, and drawing added value from the parallel enrolment and follow up.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are randomized (double‑blind) to take either nicotinamide riboside 3000 mg/day or matching placebo and are followed for 78 weeks. Follow-up includes regular in‑clinic visits, safety checks (including remote/decentralized safety reporting), rating scales for motor and non‑motor symptoms, cognitive testing, patient‑reported outcome questionnaires, and imaging (DaTSCAN/FDOPA‑PET is required at baseline and is used in outcomes). The study team will monitor for adverse events and perform routine safety tests; abnormal labs or safety concerns may affect continued participation. After completing 78 weeks, participants are offered entry into an open‑label extension where only NR is given.

How the study is structured. A randomized, placebo-controlled, double-blind Phase II trial using a basket design: three parallel, disease-specific cohorts (PSP, MSA, CBS). Within each cohort participants are assigned 1:1 to NR 3,000 mg/day or matching placebo. Follow-up lasts 78 weeks and includes in-clinic assessments, remote safety monitoring, patient questionnaires, and imaging where used; an open‑label NR extension is offered after the blinded period.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
  • The listed sites are in Norway. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on multiple system atrophy

This trial is also listed on this site under progressive supranuclear palsy.

Clinical trials76 trials listed for multiple system atrophyEvery trial the registry lists for multiple system atrophy, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in multiple system atrophy researchLatest monthly update: September 2026. Includes: Tube feeding. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Mar 5, 2024
Primary completion
December 2028 (estimated)
Study completion
December 2028 (estimated)
Target enrollment
330 participants (estimated)
Last updated on registry
Jan 10, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Haukeland University Hospital
Collaborators
  • Oslo University Hospital
  • Akershus Universitetssykehus HF
  • Vestre Viken Hospital Trust
  • Sykehuset Ostfold
  • Nevro Arendal AS
  • Helse Forde
  • Helse Fonna
  • Universitetssykehuset Nord Norge HF
  • Helse Møre og Romsdal HF
  • Nordlandssykehuset HF
  • Elysium Health

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (3)

Terms used on this page · explanations by MedicalUpdates.ai

stratified
Randomisation done separately within subgroups, such as age bands or disease severity, so that each group contains a similar mix.
randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
placebo
A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
open-label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
extension study
A continuation study in which participants who completed an earlier study can keep receiving the treatment, usually with everyone knowing what they are given.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
PET
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
at screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
investigational
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
sham
A procedure designed to resemble the real procedure, for example the same visit and equipment, without its active part. It is the procedure equivalent of a placebo.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
overall survival
The length of time from the start of the study or treatment that participants are alive, whatever the cause of death.
blinded
Who does not know which intervention a participant is receiving. It can apply to participants, the people giving the treatment, those assessing results, or those analysing the data.
1:1
How many participants go to each group. In a 2:1 ratio, two are assigned to the first group for every one assigned to the second.
enrolment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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