Study of Dopamine Transporters (signal substance in central nervous system)in patients with early signs of Parkinson´s disease.

• Register: EUCTR
• Last refreshed on: 6 October 2020
• Main ID: EUCTR2015-003045-26-SE
• Date of registration: 15/09/2015
• Prospective Registration: Yes
• Primary sponsor: Umeå University Hospital
• Public title: Study of Dopamine Transporters (signal substance in central nervous system)in patients with early signs of Parkinson´s disease.
• Scientific title: [18F] FE-PE2I PET/CT study of Dopamine Transporters in Early Parkinsonian disease.
• Date of first enrolment: 23/10/2015
• Target sample size: 105
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003045-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: no Single blind: yes Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Sweden

Contacts

• Name: Susanna Jakobson Mo
• Affiliation: Umeå University Hospital

• Name: Susanna Jakobson Mo
• Affiliation: Umeå University Hospital

Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion criteria for patients
-Woman or man, age 45-80 years who has given written informed consent to participate in the study
- For a woman in childbearing age: Negative pregnancy test in connection with inclusion and consent to the use of effective contraception (the so-called Pearl index < 1 in accordance with the Medical Products Agency recommendations) , or abstinence until 24 hours after [ 18F ] FE PE2I PET / CT respectively . 72h after DaTSCAN ™ SPECT / CT.
The following contraceptive methods provide, when used properly , a so-called Pearl index < 1: combined pills or middle-dosed gestagen oral contraceptive pills (not mini-pills ) , intra-uterine device ( IUD or IUS ) , implants , vaginal ring , contraceptive injection or transdermal patch . Female sterilization (bilateral tubarocklusion ) or sterilized male partner ( vasectomy ) is also accepted .
-Idiopathic Parkinsonism according to UK PDSBB clinical criteria for parkinsonism:
Bradykinesia + At least two of these:
• Muscular rigidity
• 4-6 Hz resting tremor
-Postural Instability (not primary visual / vestibular / proprioceptive dysfunction)
-Clinical diagnosis during the period of inclusion = idiopathic parkinsonism (NB not previously known diagnosis)
-At the time of Inclusion permanent reside in the county of Västerbotten.

Inclusion criteria for healthy subjects:
-Woman or man, age =60-80 years who has given written informed consent to participate in the study
-Subjective in generally good health for his/her age
-Objective generally good health.
-No known or suspected present disease of the nervous system (neurological or psychiatric)
-At the time of Inclusion permanent reside in the county of Västerbotten.








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 75

Exclusion criteria:
Principal exclusion criteria (list the most important, max 5000 characters)
-Severe ongoing medical condition that can be predicted to impair full participation in the study (e.g. treatment of cancer)
- Disease which prevents imaging (eg PET/CT, SPECT and MR) in prone position (e.g. severe heart failure, severe backache)
- History of stroke, TIA or known other serious neurological / neurodegenerative disorders (e.g., brain tumor, multiple sclerosis, ALS)
- Secondary parkinsonism (e.g. drug-induced Parkinsonism or obvious vascular parkinsonism)
-Known hypersensitivity to iodine
-Claustrophobia or other contraindication for MRI (e.g pacemaker or magnetic implant etc)
-Depression or other severe psychiatric condition in need of treatment (psychosis or similar severity)
-Dementia or MMSE <24
-Severe hypertension (> 180/110 mmHg)
-History of drug abuse (e.g. central stimulants or alcohol; nicotine use excepted)
-Pregnancy or breast-feeding
-Not willing to participate in the study



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

Health Condition(s) or Problem(s) studied

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

Patients with newly clinically diagnosed untreated idiopathic parkinsonism
MedDRA version: 20.0 Level: HLT Classification code 10034005 Term: Parkinson's disease and parkinsonism System Organ Class: 100000004852

Intervention(s)

Product Name: [18F]FE-PE2I
Pharmaceutical Form: Solution for injection
INN or Proposed INN: [18F]-(E)-N-(3-iodoprop-2-enyl)-2b-carbofluoroethoxy-3b-(4'-methylphenyl)nortropane
Current Sponsor code: [18F]-(E)-N-(3-iodoprop-2-enyl)-2b-carbofluoroethoxy-3b-(4'-methylphenyl)nortropane
Concentration unit: MBq megabecquerel(s)
Concentration type: up to
Concentration number: 200-

Trade Name: DaTSCAN
Pharmaceutical Form: Solution for injection
INN or Proposed INN: IOFLUPANE (123I)
CAS Number: 155798-07-5
Concentration unit: MBq megabecquerel(s)
Concentration type: equal
Concentration number: 185-

Product Name: 15O H2O
Pharmaceutical Form: Solution for injection
INN or Proposed INN: [15O]H2O
Current Sponsor code: [15O]H2O
Concentration unit: MBq megabecquerel(s)
Concentration type: equal
Concentration number: 800-

Primary Outcome(s)

Primary end point(s): -Sensitivity, specificity and predictive value of PET / CT with 18F FE PE2I in the striatum and extrastriatalt in the brain
-Statistical difference in the sensitivity and specificity of PET / CT with 18F FE PE2I (Index test) compared to SPECT / CT imaging with 123I-FP-Cit (reference test)

Secondary Objective: -To assess whether the initial dynamic phase (K1) at [18F] FE PE2I PET / CT can be used to assess rCBF
-To Investigate whether polymorphisms in the DAT-1 gene affects the BPND (and possibly the relative specific uptake) of 18F FE PE2I
-To Investigate the relationship between BPND (and possibly the relative specific uptake) of [18F] FE PE2I and clinical parameters, and to assess the relationship between BPND of [18F] FE PE2I and structural and functional MRI in relevant brain areas
-To evaluate scanning protocols, dosing and image reconstruction methods for [18F] FE PE2I PET / CT
-To analyze safety parameters at 18F PE2I PET / CT

Timepoint(s) of evaluation of this end point: The final calculation of the primary outcome measurements can be made after the clinical follow-up, two years after the imaging, when the clinical diagnosis is reassessed (gold standard in this study). An interim preliminary calculation may be done after the participants have completed [18F] FE PE2I PET/CT (index test) and 123I-FP-Cit SPECT / CT imaging (reference test)

Main Objective: To evaluate the diagnostic potential of [18F] FE PE2I PET in early untreated parkinsonian disease
To "head-to-head" compare the diagnostic accuracy of the index test (with [18F] FE PE2I PET / CT) with the reference test (123I-FP-Cit, DaTSCAN ™ SPECT/CT) in newly onset idiopathic parkinsonism

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: The final calculation of the secondary outcome measurements may be made after the participants have completed [18F] FE PE2I PET/CT

Secondary end point(s): - Statistical correlation between the initial dynamic phase (K1) of [18F] FE PE2I PET / CT and 15O H2O PET / CT
- Statistical relationship between BPND (and relative specific uptake) of [18F] FE PE2I in the presence of 9R or 10R-alleles of the DAT1 gene (SLC6A3) respectively
- Statistical correlation between BPND (and relative specific uptake) of [18F] FE PE2I and UPDRS-III,
H & Y, age and gender
- Statistical correlation between [18F] FE PE2I PET / CT and MRI in the relevant brain areas
- Adequate dosing and scanning procedure
- Effective radiation dose
- Adverse events

Secondary ID(s)

Pearl-PD

Source(s) of Monetary Support

Umeå University

Västerbottens county counsil

Ethics review

Status: Approved
Approval date: 27/01/2015
Contact: