In-vivo assessment of nicotinic acetylcholine receptor binding in neurodegenerative diseases using the radioligand 2-[18F]FA-85380 and positron emission tomography (PET) - Nicotinic-PET in neurodegenerative diseases

Phase 1

• Conditions: To test a diagnostic imaging tool for specifically assessing the nicotinic acetylcholine receptor in vivo in patients with neurodegenerative diseases

• Registration Number: EUCTR2007-004979-19-DE
• Lead Sponsor: niversity of Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-03
• Last Update Posted: 13 November 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

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

(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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: (1) In-vivo quantification of nicotinic acetylcholine receptor availability in neurodegenerative diseases<br>(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:<br>(1) correlate with clinical parameters,<br>(2) are useful for early diagnosis of neurodegenerative diseases and prediction of clinical outcome<br>(3) can improve our understanding of individual drug therapy<br>(4) are associated with environmental parameters (e.g. tobacco smoking, caffeine intake, metabolic disease) and genetic variables<br>;Primary end point(s): Imaging outcome measures: in vivo quantification of central nAChR (distribution volume ratios and binding potential) in neurodegenerative disorders