<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03816020</url>
  </required_header>
  <id_info>
    <org_study_id>2018/597</org_study_id>
    <nct_id>NCT03816020</nct_id>
  </id_info>
  <brief_title>NAD-supplementation in Drug naïve Parkinson's Disease</brief_title>
  <acronym>NAD-PARK</acronym>
  <official_title>NAD-PARK: A Double-blinded Randomized Pilot Trial of NAD-supplementation in Drug naïve Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Haukeland University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Primary objective: Determine if NR has an impact on the neurometabolic profile of&#xD;
           patients with PD as measured by [18F]Fluorodeoxyglucose (FDG)-positron emission&#xD;
           tomography (FDG-PET).&#xD;
&#xD;
        2. Secondary objective: Determine whether high dose oral NR improves motor symptoms&#xD;
           associated with PD.&#xD;
&#xD;
        3. Tertiary objectives: determine whether high dose oral NR rectifies NAD metabolism and&#xD;
           increases NAD levels in body fluids and muscle tissue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Individuals with PD (n=30) will be recruited starting 14/02/2019 from the department of&#xD;
      Neurology, Haukeland University Hospital. Only newly diagnosed and drug naïve PD patients are&#xD;
      eligible for inclusion. After initial assessment at baseline, the participants will be&#xD;
      randomly assigned (1:1) to one of two study groups (n = 15 per group): Nicotamide Riboside&#xD;
      (NR) 500 mg x 2/day, or placebo. Participants and investigators will be masked to treatment&#xD;
      group. Participants and investigators will be blinded (double blinded). The study will have a&#xD;
      4 week exposure period, during which patients will self-administer NR 500 mg x 2/day, or&#xD;
      placebo per os. Patients will not be using any dopaminergic treatment during the study&#xD;
      period. During baseline and 4 week follow-up, MDS-UPDRS will be performed as clinical&#xD;
      measure. We will also collect blood, cerebral spinal fluid and muscle biopsy from all&#xD;
      subjects at baseline and 4 week follow-up. Imaging will be performed using MRI, DAT Scan and&#xD;
      FDG-PET at baseline and 4 week follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 9, 2019</start_date>
  <completion_date type="Actual">February 10, 2020</completion_date>
  <primary_completion_date type="Actual">February 10, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>All participants and investigators will be masked.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>PDRP changes from NR use</measure>
    <time_frame>4 weeks</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Motoric change of symptoms from NR use</measure>
    <time_frame>4 weeks</time_frame>
    <description>Clinical changes measured by MDS-UPDRS from using NR</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Determine whether high dose oral NR rectifies NAD metabolism in body fluids and muscle tissue.</measure>
    <time_frame>4 weeks</time_frame>
    <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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Neurodegenerative Diseases</condition>
  <arm_group>
    <arm_group_label>NR Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receiving Nicotinamide Riboside capsules, 500mg BI'D for 30 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participant receiving Placebo BIDfor 30 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nicotinamide Riboside</intervention_name>
    <description>Nicotinamide Riboside capsules 250mg x 2 BID</description>
    <arm_group_label>NR Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo capsules BID</description>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Newly diagnosed with PD&#xD;
&#xD;
          2. Drug naïve with respect to dopaminergic treatment&#xD;
&#xD;
          3. Have a clinical diagnosis of idiopathic PD according to the MDS clinical diagnostic&#xD;
             criteria for PD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. [¹²³I]FP-CIT single photon emission CT (DaTscan) does not show nigrostriatal&#xD;
             degeneration.&#xD;
&#xD;
          2. Magnetic resonance imaging (MRI) suggestive of atypical parkinsonsism.&#xD;
&#xD;
          3. Dementia or other neurological disorder at baseline visit&#xD;
&#xD;
          4. Metabolic, neoplastic, or other physically or mentally debilitating disorder at&#xD;
             baseline visit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charalampos Tzoulis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nevro-Sysmed</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <state>Hordaland</state>
        <zip>5021</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>February 10, 2020</last_update_submitted>
  <last_update_submitted_qc>February 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>clinical pilot, Nicotamide Riboside, Parkinson's Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Neurodegenerative Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Niacinamide</mesh_term>
    <mesh_term>Niacin</mesh_term>
    <mesh_term>Nicotinic Acids</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will only be shared if there is scientific collaboration. Will not be publicaly shared.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03816020
org study id: 2018/597
nct id: NCT03816020
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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. Tertiary objectives: determine whether high dose oral NR rectifies NAD metabolism and
           increases NAD levels in body fluids and muscle tissue.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Investigator)
masking description: All participants and investigators will be masked.
measure: PDRP changes from NR use
time frame: 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.
measure: Motoric change of symptoms from NR use
time frame: 4 weeks
description: Clinical changes measured by MDS-UPDRS from using NR
measure: Determine whether high dose oral NR rectifies NAD metabolism in body fluids and muscle tissue.
time frame: 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.
arm group label: NR Group
arm group type: Active Comparator
description: Participants receiving Nicotinamide Riboside capsules, 500mg BI'D for 30 days
arm group label: Placebo Group
arm group type: Placebo Comparator
description: Participant receiving Placebo BIDfor 30 days
intervention type: Dietary Supplement
intervention name: Nicotinamide Riboside
description: Nicotinamide Riboside capsules 250mg x 2 BID
arm group label: NR Group
intervention type: Other
intervention name: Placebo
description: Placebo capsules BID
arm group label: Placebo Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Charalampos Tzoulis, PhD
role: Principal Investigator
affiliation: Nevro-Sysmed
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Neurodegenerative Diseases
mesh term: Niacinamide
mesh term: Niacin
mesh term: Nicotinic Acids
sharing ipd: No
ipd description: Data will only be shared if there is scientific collaboration. Will not be publicaly shared.