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

Phase 1

• Conditions: Patients with newly clinically diagnosed untreated idiopathic parkinsonism; MedDRA version: 20.0Level: HLTClassification code 10034005Term: Parkinson's disease and parkinsonismSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-003045-26-SE
• Lead Sponsor: meå University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-15
• Last Update Posted: 6 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 105

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

Study & Design

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