Parkinson's disease
Conditions
Interventions
None listed
Sponsors
1st Biotherapeutics Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Participant understands the study procedures in the informed consent form and is willing and able to comply with the study prescriptions - Signed informed consent form - Diagnosis of PD according to the Movement Disorder Society (MDS) clinical diagnostic criteria (applicable to participants with Parkinson's Disease) - Abnormal DAT-SPECT (applicable to participants with Parkinson's Disease) - Age 40 years or older - Medically healthy with no abnormalities at short neurological and physical examination (applicable to healthy volunteers)
Exclusion criteria
Exclusion criteria: - Inability to undergo MRI, e.g. metal objects in or around the body, claustrophobia or inability to lie still in the scanner - Inability to undergo PET-CT with administration of radioligand [18F]FB610, including inability to lie still for 90 minutes. - (History of) other relevant neurological disease - (History of) malignancy - Known significant cardiac disease - Relevant history of severe drug allergy or hypersensitivity - Inadequate renal function: creatinine clearance 45 U/L and ASAT >35 U/L, in female subjects ALAT >34 U/L and ASAT>31 U/L - Loss or donation of blood over 500 mL within four months prior to study visits - In male subjects Hb
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are the [18F]FB610 binding as a measure of c-Abl in PD patients and healthy volunteers, to assess the radiation dose and assess its safety, and to identify the most suitable tracer kinetic method for quantification of [18F]FB610 binding. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters include the difference between binding of the radioligand [18F]FB610 in PD patients and healthy volunteers to determine whether c-Abl expression may be increased in PD patients. | — |
Countries
Netherlands
Outcome results
None listed