N/A N=7

Study to Investigate the Ability of [11C]Donepezil PET to Image the Parasympathetic Nervous System

Parkinson's Disease

Bottom Line

View on ClinicalTrials.gov: NCT01877538 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2016

Primary outcome: Primary: Distribution Volume (DV) of [11C]Donepezil - BASELINE — 18.0; 22.1; 21.4; 26.6 mL

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: [11C]donepezil PET (Other)
Age: Adult, Older Adult · 45+ yrs
Sex: Male
Sponsor: Per Borghammer
Primary completion: Jul 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Distribution Volume (DV) of [11C]Donepezil - BASELINE	18.0; 22.1; 21.4; 26.6; 46.8; 103.9	—
PRIMARY Standard Uptake Value (SUV) of [11C]Donepezil - BASELINE	2.3; 3.9; 3.7; 4.8; 7.4; 11.7	—

Summary

AIM: To validate the tracer [11C]donepezil for use in the parasympathetic nervous system. MATERIALS AND METHODS: The Investigators will include 7 healthy males aged 45-75 in our study. The participants will receive a careful medical examination, including a neurological examination, as part of the inclusion process. The subjects also have an MRI scan of the brain. PET/CT scans with [11C]donepezil are conducted. Six subjects will receive two PET/CT scans - once for the upper abdominal region and once for the head region two evaluate dynamic binding characteristics of the tracer in internal organ. Additionally, one single subject will receive 5 consecutive whole body PET scans to estimate radioactive dosimetry of this tracer. PERSPECTIVES: The study will potentially result in the development of a PET ligand for imaging the parasympathetic nervous system. This will have applications for research in Parkinson's disease, diabetes, heart disease and other disorders, in which the autonomic nervous system is involved

Eligibility Criteria

Inclusion Criteria

male
45-75 years

Exclusion Criteria

dementia,
psychiatric diseases,
serious medical illness including any type of previous cancer, any drug with known interaction with the autonomic nervous system

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01877538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.