NAD-supplementation in Drug naïve Parkinson's Disease

NAD-PARK: A Double-blinded Randomized Pilot Trial of NAD-supplementation in Drug naïve Parkinson's Disease

Patrocinadores

Patrocinador principal: Haukeland University Hospital

Fuente Haukeland University Hospital
Resumen breve

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.

Descripción detallada

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.

Estado general Completed
Fecha de inicio March 9, 2019
Fecha de Terminación February 10, 2020
Fecha de finalización primaria February 10, 2020
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
PDRP changes from NR use 4 weeks
Resultado secundario
Medida Periodo de tiempo
Motoric change of symptoms from NR use 4 weeks
Inscripción 30
Condición
Intervención

Tipo de intervención: Dietary Supplement

Nombre de intervención: Nicotinamide Riboside

Descripción: Nicotinamide Riboside capsules 250mg x 2 BID

Etiqueta de grupo de brazo: NR Group

Tipo de intervención: Other

Nombre de intervención: Placebo

Descripción: Placebo capsules BID

Etiqueta de grupo de brazo: Placebo Group

Elegibilidad

Criterios:

Inclusion Criteria:

1. Newly diagnosed with PD

2. Drug naïve with respect to dopaminergic treatment

3. Have a clinical diagnosis of idiopathic PD according to the MDS clinical diagnostic criteria for PD

Exclusion Criteria:

1. [¹²³I]FP-CIT single photon emission CT (DaTscan) does not show nigrostriatal degeneration.

2. Magnetic resonance imaging (MRI) suggestive of atypical parkinsonsism.

3. Dementia or other neurological disorder at baseline visit

4. Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Charalampos Tzoulis, PhD Principal Investigator Nevro-Sysmed
Ubicación
Instalaciones: Haukeland University Hospital
Ubicacion Paises

Norway

Fecha de verificación

February 2020

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: NR Group

Tipo: Active Comparator

Descripción: Participants receiving Nicotinamide Riboside capsules, 500mg BI`D for 30 days

Etiqueta: Placebo Group

Tipo: Placebo Comparator

Descripción: Participant receiving Placebo BIDfor 30 days

Acrónimo NAD-PARK
Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Descripción del modelo de intervención: 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.

Propósito primario: Basic Science

Enmascaramiento: Triple (Participant, Care Provider, Investigator)

Descripción de enmascaramiento: All participants and investigators will be masked.

Fuente: ClinicalTrials.gov