Brain amyloid beta burden as per florbetaben PET

Phase 1

• Conditions: Parkinson's Disease; MedDRA version: 19.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-001014-25-ES
• Lead Sponsor: Fundació Clínic per la Recerca Biomèdica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-15
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.PD patients aged 60 to 69 years,
2.Motor fluctuations refractory to the best medical treatment that have led to the indication of STN-DBS;
3.Commitment to participate and complete all study procedures according to the principal investigator;
4.Voluntary fulfilment and signature of the study Informed Consent Form.
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1.Subjects not eligible for STN-DBS (due to presence of one or more exclusion criteria for STN-DBS including the possibility of a diagnosis different to PD, such as any of the atypical parkinsonisms) or likely not to be able to complete the study;
2.PD-related dementia according to the MDS definition of PD-dementia;
3.Any major disease or history of a major disease, especially hepatobilliar disease (AST /ALT = 5 x ULN) or advanced renal insufficiency (creatinine = 2 x ULN);
4.Current or previous history of alcohol abuse or epilepsy;
5.Allergy to FBB or any of its constituents;
6.Multiple drug allergies and/or previous history of contrast allergy;
7.Pregnancy or breast feeding or planned pregnancy during the study period;
8.Any disease or history of disease which, in the opinion of the investigator, can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function);
9.Evidence for any other neurological or psychiatric disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified