Brain SPECT in premotor stage of Parkinson disease

Phase 1

Conditions: Parkinson disease
MedDRA version: 18.1Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2015-004238-85-ES

Lead Sponsor: IDIBAPS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Patients:
?RBD diagnosis (International classification of Sleep disorders-2 criteria)
?Idiopatic RBD (non related with neurological diseases nor drug-treatment related,?)
?Patient can attend to visits

Healthy volunteers:
?Subjects without associated active neurological disease
?Subjects without any relation with investigational team
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

?Diagnosis of mild cognitive impairment or dementia
?Presence of parkinsonian symptom
?Serious medical pathology that can interfere with the performance of tests and clinical data.
?Hypersensitivity to the active substance or any of the excipients
?Subjects with low sodium diet.
?Participation in other clinical trial during the 30 days prior to the study .
?Pregnancy or breastfeeding

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Identify differences in image over areas with hypo- and hyperperfusion during REM sleep in patients with IRBD regarding the images obtained in healthy volunteers;Secondary Objective: Safety analysis;Primary end point(s): Identification of brain areas that are hyper and hypo activated during REM phase (z score SISCOM software);Timepoint(s) of evaluation of this end point: Baseline (day of SPECT)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): number of adverse events (AE)<br>number of serious adverse events (SAE)<br>number of adverse reactions (AR)<br>number of serious adverse reactions (SAR)<br>number of unexpected serious adverse reactions (SUSAR)<br>number of patients with AE,SAE, AR, SAR and SUSAR;Timepoint(s) of evaluation of this end point: 1 week after treatment