To test a diagnostic imaging tool for specifically assessing the nicotinic acetylcholine receptor in vivo in patients with neurodegenerative diseases
Conditions
Interventions
Product Name: 2-[18F]Fluoro-3-(2(S)-azetidinylmethoxy)pyridine
Product Code: 2-[18F]Fluor-A-85380
Pharmaceutical Form: Solution for injection
Sponsors
University of Leipzig
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients: neurodegenerative diseases (dementia, movement disorders, white matter diseases) according to the disease specific diagnostic criteria (DSM V, ICD-10) including also neuropsychological tests (CDR, NINCDS-ADRDA, MMSE, DemTect, UPDRS, EDSS) (2) Patients: must be compliant and willing to give informed consent (3) Patients: should not have cholinergic drugs prior scanning (more than 2 weeks cessation) (4) Control subjects: no history of or current neuropsychiatric disease or drug treatment/abuse, no intracerebral structural defects (5) Age: 18 - 90 years 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (1) Patients with drug-/ or alcohol abuse (2) Severe phobia/reduced compliance that make PET investigation impossible or other diseases that do not allow PET or MRI scanning (3) Pregnancy (4) Malignant brain tumor (5) History of choline esterase inhibitors (CHEI) (6) Smoking (7) For healthy controls: history of neurological or psychiatric disorders, pathological MRI scan (8) Lack of compliance (9) Previous radiation exposure in profession or in studies (10) Abnormal blood/urine testing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: (1) In-vivo quantification of nicotinic acetylcholine receptor availability in neurodegenerative diseases (2) To find diagnostic patterns of altered in-vivo nicotinic acetylcholine receptor binding in neurodegenerative disease;Secondary Objective: To assess whether these patterns of altered nicotinic acetylcholine receptor binding in neurodegenerative diseases: (1) correlate with clinical parameters, (2) are useful for early diagnosis of neurodegenerative diseases and prediction of clinical outcome (3) can improve our understanding of individual drug therapy (4) are associated with environmental parameters (e.g. tobacco smoking, caffeine intake, metabolic disease) and genetic variables ;Primary end point(s): Imaging outcome measures: in vivo quantification of central nAChR (distribution volume ratios and binding potential) in neurodegenerative disorders | — |
Countries
Germany
Outcome results
None listed