Progressive Supranuclear PalsyPhase 2NADAPTNCT06162013
The NADAPT Study: a Randomized Double-blind Trial of NAD Replenishment Therapy for Atypical Parkinsonism
A Phase 2 study testing Nicotinamide Riboside in people with Progressive Supranuclear Palsy and Multiple System Atrophy, run by Haukeland University Hospital at 3 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Progressive Supranuclear Palsy, Multiple System Atrophy, Corticobasal Syndrome
- What is being tested?
- Nicotinamide Riboside
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 3 sitesNorway
- Study dates
- 5 Mar 2024to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Gard Aasmund Skulstad Johanson, MD contact
Norway3 sites, 3 recruiting
- Recruiting
Haukeland University Hospital
Bergen, Vestland, 5021
Charalampos Tzoulis, MD, PhD, 55975061 ext. 47, charalampos.tzoulis@helse-bergen.no
Gard Aasmund Skulstad Johanson, MD, 55975045 ext. 47, gard.aasmund.skulstad.johanson@helse-bergen.no
- Recruiting
Vestre Viken HF
Drammen
Kari Anne Bjørnarå, M.D., Ph.D., 47 92668493, Kari.Anne.Bjornara@vestreviken.no
Kari Anne Bjørnarå, M.D., Ph.D.
- Recruiting
Oslo University Hospital
Oslo, Oslo, 0424
Lasse Pihlstrøm, MD, PhD, 91592770, lasse.pihlstrom@medisin.uio.no
About this study
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Nicotinamide Riboside, Placebo
- Medical subject headings
- Supranuclear Palsy, Progressive, Multiple System Atrophy, Corticobasal Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide RibosideDietary supplement
Also called NR
Nicotinamide Riboside 3000mg/day
PlaceboOther
Placebo. Identical in taste and appearance as the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Following our basket trial design, there will be three parallel intervention cohorts (one per disease/cohort) Receives: Dietary Supplement: Nicotinamide Riboside |
| Placebo | Placebo comparator | Following our basket trial design, there will be three parallel placebo cohorts (one per disease/cohort) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSP Cohort: Between group difference in PSP Rating Scale (PSPRS) total score from baseline to week 78
Our primary outcome measure for the PSP Cohort is the between group (placebo or NR) difference in Progressive Supranuclear Palsy Rating Scale (PSPRS) total score from baseline to week 78.
Measured: 78 weeks
MSA Cohort: Between group difference in Unified MSA Rating Scale (UMSARS) total score from baseline to week 78
Our primary outcome measure for the MSA Cohort is the between group (placebo or NR) difference in the Unified Multiple System Atrophy Rating Scale (UMSARS) total score from baseline to week 78.
Measured: 78 weeks
CBS Cohort: Between group difference in PSP Rating Scale (PSPRS) total score from baseline to week 78
Our primary outcome measure for the CBS Cohort is the between group (placebo or NR) difference in Progressive Supranuclear Palsy Rating Scale (PSPRS) total score from baseline to week 78.
Measured: 78 weeks
Secondary outcomes (9)
Safety and tolerability
Monitor frequency and severity of adverse events (AE)
Measured: 79 weeks (Trial duration of 78 weeks plus 7 days after last dose of intervention or placebo)
Specific motor/non-motor symptoms, activities of daily function, and quality of life as measured by the PSPRS
Measured by individual items of the PSPRS
Measured: 78 weeks
Specific motor/non-motor symptoms, activities of daily function, and quality of life as measured by the UMSARS
Measured by individual items of the UMSARS
Measured: 78 weeks
Specific motor/non-motor symptoms, activities of daily function, and quality of life as measured by the UPDRS
Measured by individual items of the Movement disorders society unified parkinson's disease rating scale (UPDRS)
Measured: 78 weeks
Specific motor/non-motor symptoms, activities of daily function, and quality of life as measured by the MoCA
Measured by individual items of the Montreal Cognitive Assesment (MoCA)
Measured: 78 weeks
Specific motor/non-motor symptoms, activities of daily function, and quality of life as measured by the SEADL
Measured by individual items of the Schwab and England Activities of Daily Living (SEADL)
Measured: 78 weeks
Specific motor/non-motor symptoms, activities of daily function, and quality of life as measured by the PSP-QoL
Measured by individual items of the PSP Quality of Life questionnaire (PSP-QoL)
Measured: 78 weeks
Specific motor/non-motor symptoms, activities of daily function, and quality of life as measured by the MSA-QoL
Measured by individual items of the MSA Quality of Life questionnaire (MSA-QoL)
Measured: 78 weeks
Nigrostriatal degeneration
DaTSCAN tracer uptake in the striatum (total and anatomical parts).
Measured: 78 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start5 Mar 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Supranuclear PalsyStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 130 patients with PSP, 165 patients with MSA, and an undetermined number of patients with CBS will be stratified into cohorts 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 with parallel cohorts, essentially encompassing three trials in one, and drawing added value from the parallel enrolment and follow up.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Charalampos Tzoulis, MD, PhD, Study director, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162013
- Sponsor's protocol ID
- 2023/634814
- Other IDs
- 2023/634814, 2023
- Acronym
- NADAPT
- Status last verified
- Oct 2024
- First submitted
- 17 Nov 2023
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The NADAPT Study: a Randomized Double-blind Trial of NAD Replenishment Therapy for Atypical Parkinsonism
- ClinicalTrials.gov ID
- NCT06162013
- Acronym / sponsor ID
- NADAPT / 2023/634814
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- 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
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 130 patients with PSP, 165 patients with MSA, and an undetermined number of patients with CBS will be stratified into cohorts 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 with parallel cohorts, essentially encompassing three trials in one, and drawing added value from the parallel enrolment and follow up.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: Nicotinamide RibosideFollowing our basket trial design, there will be three parallel intervention cohorts (one per disease/cohort) |
| Placebo | Placebo comparator | Other: PlaceboFollowing our basket trial design, there will be three parallel placebo cohorts (one per disease/cohort) |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotinamide RibosideAlso: NRNicotinamide Riboside 3000mg/day | Dietary supplement | Intervention |
| PlaceboPlacebo. Identical in taste and appearance as the intervention. | Other | Placebo |
Primary outcome
PSP Cohort: Between group difference in PSP Rating Scale (PSPRS) total score from baseline to week 78
Time frame: 78 weeks
Our primary outcome measure for the PSP Cohort is the between group (placebo or NR) difference in Progressive Supranuclear Palsy Rating Scale (PSPRS) total score from baseline to week 78.
MSA Cohort: Between group difference in Unified MSA Rating Scale (UMSARS) total score from baseline to week 78
Time frame: 78 weeks
Our primary outcome measure for the MSA Cohort is the between group (placebo or NR) difference in the Unified Multiple System Atrophy Rating Scale (UMSARS) total score from baseline to week 78.
CBS Cohort: Between group difference in PSP Rating Scale (PSPRS) total score from baseline to week 78
Time frame: 78 weeks
Our primary outcome measure for the CBS Cohort is the between group (placebo or NR) difference in Progressive Supranuclear Palsy Rating Scale (PSPRS) total score from baseline to week 78.
9 secondary outcomes
Safety and tolerability
Time frame: 79 weeks (Trial duration of 78 weeks plus 7 days after last dose of intervention or placebo)
Specific motor/non-motor symptoms, activities of daily function, and quality of life as measured by the PSPRS
Time frame: 78 weeks
Specific motor/non-motor symptoms, activities of daily function, and quality of life as measured by the UMSARS
Time frame: 78 weeks
Specific motor/non-motor symptoms, activities of daily function, and quality of life as measured by the UPDRS
Time frame: 78 weeks
Specific motor/non-motor symptoms, activities of daily function, and quality of life as measured by the MoCA
Time frame: 78 weeks
Specific motor/non-motor symptoms, activities of daily function, and quality of life as measured by the SEADL
Time frame: 78 weeks
Specific motor/non-motor symptoms, activities of daily function, and quality of life as measured by the PSP-QoL
Time frame: 78 weeks
Specific motor/non-motor symptoms, activities of daily function, and quality of life as measured by the MSA-QoL
Time frame: 78 weeks
Nigrostriatal degeneration
Time frame: 78 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Study website (Norwegian only)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gard Aasmund Skulstad Johanson, MD contact
Charalampos Tzoulis, MD, PhD study director
Haukeland University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotinamide Riboside in people with Progressive Supranuclear Palsy and Multiple System Atrophy, run by Haukeland University Hospital at 3 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Geir Olve Skeie, MD, Dr.med (55975045 ext. 47, geir.olve.skeie@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSP Cohort: Between group difference in PSP Rating Scale (PSPRS) total score from baseline to week 78 (time frame: 78 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025; AzTrials last refreshed its copy on 2 Nov 2026.