Parkinson DiseaseNAD-PARKNCT03816020
NAD-supplementation in Drug naïve Parkinson's Disease
A study testing Nicotinamide Riboside in people with Parkinson Disease and Neurodegenerative Diseases, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
1. Primary objective: Determine if NR has an impact on the neurometabolic profile of patients with PD as measured by [18F]Fluorodeoxyglucose (FDG)-positron emission tomography (FDG-PET). 2. Secondary objective: Determine whether high dose oral NR improves motor symptoms associated with PD. 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Neurodegenerative Diseases
- What is being tested?
- Nicotinamide Riboside
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 9 Mar 2019to 10 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed with PD
- Drug naïve with respect to dopaminergic treatment
- Have a clinical diagnosis of idiopathic PD according to the MDS clinical diagnostic criteria for PD
Who cannot join
- [¹²³I]FP-CIT single photon emission CT (DaTscan) does not show nigrostriatal degeneration.
- Magnetic resonance imaging (MRI) suggestive of atypical parkinsonsism.
- Dementia or other neurological disorder at baseline visit
- Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NAD-PARK: A Double-blinded Randomized Pilot Trial of NAD-supplementation in Drug naïve Parkinson's Disease
- Primary objective: Determine if NR has an impact on the neurometabolic profile of patients with PD as measured by [18F]Fluorodeoxyglucose (FDG)-positron emission tomography (FDG-PET).
- Secondary objective: Determine whether high dose oral NR improves motor symptoms associated with PD.
- Tertiary objectives: determine whether high dose oral NR rectifies NAD metabolism and increases NAD levels in body fluids and muscle tissue.
Read the detailed description
Individuals with PD (n=30) will be recruited starting 14/02/2019 from the department of Neurology, Haukeland University Hospital. Only newly diagnosed and drug naïve PD patients are eligible for inclusion. After initial assessment at baseline, the participants will be randomly assigned (1:1) to one of two study groups (n = 15 per group): Nicotamide Riboside (NR) 500 mg x 2/day, or placebo. Participants and investigators will be masked to treatment group. Participants and investigators will be blinded (double blinded). The study will have a 4 week exposure period, during which patients will self-administer NR 500 mg x 2/day, or placebo per os. Patients will not be using any dopaminergic treatment during the study period. During baseline and 4 week follow-up, MDS-UPDRS will be performed as clinical measure. We will also collect blood, cerebral spinal fluid and muscle biopsy from all subjects at baseline and 4 week follow-up. Imaging will be performed using MRI, DAT Scan and FDG-PET at baseline and 4 week follow-up.
- Conditions
- Parkinson Disease, Neurodegenerative Diseases
- Being tested
- Nicotinamide Riboside, Placebo
- Keywords
- clinical pilot, Nicotamide Riboside, Parkinson's Disease
- Medical subject headings
- Parkinson Disease, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide RibosideDietary supplement
Nicotinamide Riboside capsules 250mg x 2 BID
PlaceboOther
Placebo capsules BID
| Study group | Role | What they receive |
|---|---|---|
| NR Group | Active comparator | Participants receiving Nicotinamide Riboside capsules, 500mg BI'D for 30 days Receives: Dietary Supplement: Nicotinamide Riboside |
| Placebo Group | Placebo comparator | Participant receiving Placebo BIDfor 30 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PDRP changes from NR use
The primary outcome will be the between-group difference in Parkinson's disease related pattern (PDRP) measured by FDG-PET comparing baseline and 3-4 week follow-up measurement.
Measured: 4 weeks
Secondary outcomes (1)
Motoric change of symptoms from NR use
Clinical changes measured by MDS-UPDRS from using NR
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start9 Mar 2019
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After initial assessment at baseline, the participants will be randomly assigned (1:1) to one of two study groups (n = 15 per group): NR 500 mg x 2/day, or placebo. Participants and investigators will be masked to treatment group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charalampos Tzoulis, PhD, Principal investigator, Nevro-Sysmed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816020
- Sponsor's protocol ID
- 2018/597
- Acronym
- NAD-PARK
- Status last verified
- Feb 2020
- First submitted
- 7 Dec 2018
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will only be shared if there is scientific collaboration. Will not be publicaly shared.
Publications
Brakedal B, Dolle C, Riemer F, Ma Y, Nido GS, Skeie GO, Craven AR, Schwarzlmuller T, Brekke N, Diab J, Sverkeli L, Skjeie V, Varhaug K, Tysnes OB, Peng S, Haugarvoll K, Ziegler M, Gruner R, Eidelberg D, Tzoulis C. The NADPARK study: A randomized phase I trial of nicotinamide riboside supplementation in Parkinson's disease. Cell Metab. 2022 Mar 1;34(3):396-407.e6. doi: 10.1016/j.cmet.2022.02.001.
PubMed 35235774
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NAD-PARK: A Double-blinded Randomized Pilot Trial of NAD-supplementation in Drug naïve Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03816020
- Acronym / sponsor ID
- NAD-PARK / 2018/597
- Conditions
- Parkinson Disease, Neurodegenerative Diseases
- Keywords
- clinical pilot, Nicotamide Riboside, Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 9 Mar 2019 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 25 Jan 2019 (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.
- Primary objective: Determine if NR has an impact on the neurometabolic profile of patients with PD as measured by [18F]Fluorodeoxyglucose (FDG)-positron emission tomography (FDG-PET).
- Secondary objective: Determine whether high dose oral NR improves motor symptoms associated with PD.
- Tertiary objectives: determine whether high dose oral NR rectifies NAD metabolism and increases NAD levels in body fluids and muscle tissue.
Detailed description
Individuals with PD (n=30) will be recruited starting 14/02/2019 from the department of Neurology, Haukeland University Hospital. Only newly diagnosed and drug naïve PD patients are eligible for inclusion. After initial assessment at baseline, the participants will be randomly assigned (1:1) to one of two study groups (n = 15 per group): Nicotamide Riboside (NR) 500 mg x 2/day, or placebo. Participants and investigators will be masked to treatment group. Participants and investigators will be blinded (double blinded). The study will have a 4 week exposure period, during which patients will self-administer NR 500 mg x 2/day, or placebo per os. Patients will not be using any dopaminergic treatment during the study period. During baseline and 4 week follow-up, MDS-UPDRS will be performed as clinical measure. We will also collect blood, cerebral spinal fluid and muscle biopsy from all subjects at baseline and 4 week follow-up. Imaging will be performed using MRI, DAT Scan and FDG-PET at baseline and 4 week follow-up.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- After initial assessment at baseline, the participants will be randomly assigned (1:1) to one of two study groups (n = 15 per group): NR 500 mg x 2/day, or placebo. Participants and investigators will be masked to treatment group.
| Arm | Type | Receives |
|---|---|---|
| NR Group | Active comparator | Dietary Supplement: Nicotinamide RibosideParticipants receiving Nicotinamide Riboside capsules, 500mg BI'D for 30 days |
| Placebo Group | Placebo comparator | Other: PlaceboParticipant receiving Placebo BIDfor 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Newly diagnosed with PD
- Drug naïve with respect to dopaminergic treatment
- Have a clinical diagnosis of idiopathic PD according to the MDS clinical diagnostic criteria for PD
Key exclusion criteria (4 listed)
- [¹²³I]FP-CIT single photon emission CT (DaTscan) does not show nigrostriatal degeneration.
- Magnetic resonance imaging (MRI) suggestive of atypical parkinsonsism.
- Dementia or other neurological disorder at baseline visit
- Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit
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 RibosideNicotinamide Riboside capsules 250mg x 2 BID | Dietary supplement | NR Group |
| PlaceboPlacebo capsules BID | Other | Placebo Group |
Primary outcome
PDRP changes from NR use
Time frame: 4 weeks
The primary outcome will be the between-group difference in Parkinson's disease related pattern (PDRP) measured by FDG-PET comparing baseline and 3-4 week follow-up measurement.
1 secondary outcome
Motoric change of symptoms from NR use
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Derived from this study: PubMed 35235774Brakedal B, Dolle C, Riemer F, Ma Y, Nido GS, Skeie GO, Craven AR, Schwarzlmuller T, Brekke N, Diab J, Sverkeli L, Skjeie V, Varhaug K, Tysnes OB, Peng S, Haugarvoll K, Ziegler M, Gruner R, Eidelberg D, Tzoulis C. The NADPARK study: A randomized phase I trial of nicotinamide riboside supplementation in Parkinson's disease. Cell Metab. 2022 Mar 1;34(3):396-407.e6. doi: 10.1016/j.cmet.2022.02.001.
- Individual participant dataSharing planned: No. Data will only be shared if there is scientific collaboration. Will not be publicaly shared.
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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. This study is not recruiting at the moment.
Charalampos Tzoulis, PhD principal investigator
Nevro-Sysmed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotinamide Riboside in people with Parkinson Disease and Neurodegenerative Diseases, run by Haukeland University Hospital at 1 site 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PDRP changes from NR use (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03816020, which also lists 1 linked publication.
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 12 Feb 2020.