Brain SPECT in premotor stage of Parkinson disease

Ictal brain SPECT in the premotor stage of Parkinson disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004238-85-ES

Enrollment

Registered

2015-12-10

Start date

2016-01-27

Completion date

Unknown

Last updated

2018-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson disease MedDRA version: 18.1 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: CERETEC (TM) Estabilizado Product Name: Ceretec Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Ceretec CAS Number: 100504-35-6 Other descriptive name: TECHNETI

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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

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

Countries

Spain

Contacts

Public ContactServei Neurologia H. Clinic

Hospital Clínic

jsantama@clinic.ub.es0034932275400

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026