Brain amyloid beta burden as per florbetaben PET

• Register: EUCTR
• Last refreshed on: 8 August 2016
• Main ID: EUCTR2014-001014-25-ES
• Date of registration: 15/07/2016
• Prospective Registration: Yes
• Primary sponsor: Fundació Clínic per la Recerca Biomèdica
• Public title: Brain amyloid beta burden as per florbetaben PET
• Scientific title: Brain Amyloid-Beta burden as per florbetaben (Neuraceq) pet and cognitive outcomes after deep brain stimulation in Parkinsin's disease
• Date of first enrolment: 20/07/2016
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-001014-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Spain

Contacts

• Name: Sara Varea
• Affiliation: CTU CLINIC

• Name: Sara Varea
• Affiliation: CTU CLINIC

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Parkinson's Disease
MedDRA version: 19.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Trade Name: Neuraceq
Product Name: Neuraceq
Pharmaceutical Form: Solution for injection
INN or Proposed INN: FLORBETABEN (18F)
CAS Number: 902143-01-5
Current Sponsor code: Piramal Imaging GmbH
Concentration unit: MBq/mg megabecquerel(s)/milligram
Concentration type: equal
Concentration number: 300-

Primary Outcome(s)

Primary end point(s): - Incidence of adverse events of a single dose of FBB followed by PET scan in PD patients about to undergo DBS.
- Proportion of + FBB PET scans at baseline
- Proportion of patients with clinical important differences for each outcome measure including the proportion of patients progressing to dementia at 18 months (if any).

Main Objective: Assess safety of FBB PET Brain scan pre surgery in Parkinson diseade (PD) patients

Timepoint(s) of evaluation of this end point: 18 months

Secondary Objective: Assess the proportion of FBB PET positive scans at baseline to the cut off in our reference population
compare longitudinal changes in global, motor,cognitive and behavioural outcomes
comparing progressing to dementia patients if any
- comparing diferences in FBBPET between patients with worsening vs who doesn't

Secondary Outcome(s)

Secondary end point(s): 1. Significant correlations of longitudinal changes in motor, neuropsychological, and neuropsychiatric scores with SUVRs of baseline FBB-PET.
2. Significant differences in regional SUVR between PD patients experiencing motor, neuropsychological or neuropsychiatric worsening at follow-up and those remaining stable or getting better.
3. Cortical pattern of amyloid deposition in PD patients upon visual and quantitative examination

Timepoint(s) of evaluation of this end point: 18 months

Secondary ID(s)

FBB-DBS-2014

Source(s) of Monetary Support

Fundació Clínic per a la Recerca Biomèdica