Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT03816020
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2018-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NAD-supplementation in Drug naïve Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C018613', 'term': 'nicotinamide-beta-riboside'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'All participants and investigators will be masked.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-10', 'studyFirstSubmitDate': '2018-12-07', 'studyFirstSubmitQcDate': '2019-01-21', 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Determine whether high dose oral NR rectifies NAD metabolism in body fluids and muscle tissue.', 'timeFrame': '4 weeks', 'description': 'To measure NAD a liquid chromatography/tandem mass spectrometry will be use (abrv platform for method is LC-MS/MS.) We are interested in change of value of NAD. There is to our knowledge no measured NAD levels of PD patients. See PMID: 29184669 for the same method that we will use.'}], 'primaryOutcomes': [{'measure': 'PDRP changes from NR use', 'timeFrame': '4 weeks', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Motoric change of symptoms from NR use', 'timeFrame': '4 weeks', 'description': 'Clinical changes measured by MDS-UPDRS from using NR'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["clinical pilot, Nicotamide Riboside, Parkinson's Disease"], 'conditions': ['Parkinson Disease', 'Neurodegenerative Diseases']}, 'referencesModule': {'references': [{'pmid': '35235774', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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).\n2. Secondary objective: Determine whether high dose oral NR improves motor symptoms associated with PD.\n3. Tertiary objectives: determine whether high dose oral NR rectifies NAD metabolism and increases NAD levels in body fluids and muscle tissue.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Newly diagnosed with PD\n2. Drug naïve with respect to dopaminergic treatment\n3. Have a clinical diagnosis of idiopathic PD according to the MDS clinical diagnostic criteria for PD\n\nExclusion Criteria:\n\n1. \\[¹²³I\\]FP-CIT single photon emission CT (DaTscan) does not show nigrostriatal degeneration.\n2. Magnetic resonance imaging (MRI) suggestive of atypical parkinsonsism.\n3. Dementia or other neurological disorder at baseline visit\n4. Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit'}, 'identificationModule': {'nctId': 'NCT03816020', 'acronym': 'NAD-PARK', 'briefTitle': "NAD-supplementation in Drug naïve Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': "NAD-PARK: A Double-blinded Randomized Pilot Trial of NAD-supplementation in Drug naïve Parkinson's Disease", 'orgStudyIdInfo': {'id': '2018/597'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NR Group', 'description': "Participants receiving Nicotinamide Riboside capsules, 500mg BI'D for 30 days", 'interventionNames': ['Dietary Supplement: Nicotinamide Riboside']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Participant receiving Placebo BIDfor 30 days', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Nicotinamide Riboside', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Nicotinamide Riboside capsules 250mg x 2 BID', 'armGroupLabels': ['NR Group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo capsules BID', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5021', 'city': 'Bergen', 'state': 'Hordaland', 'country': 'Norway', 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Charalampos Tzoulis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nevro-Sysmed'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will only be shared if there is scientific collaboration. Will not be publicaly shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}