Completed

Whole Body Study of [11C]NNC-112 PET Imaging of Dopamine D1 Receptors

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What is being tested

Data Collection

Who is being recruted

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2004
See protocol details

Summary

Principal SponsorNational Institute of Mental Health (NIMH)
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2004Actual date on which the first participant was enrolled.

Abnormalities in dopaminergic neurotransmission have been implicated in several neurodegenerative and psychiatric disorders, such as Parkinson's disease, schizophrenia, attention-deficit-hyperactivity disorder and drug dependence. Among the Dopamine (DA) receptors, D1 receptors are understood to be involved in the regulation of motor and cognitive activity by modulating DAergic function. Neuroreceptor imaging with Positron Emission Tomography (PET) and Single Photon Emission Computerized Tomography (SPECT) allows in vivo quantification of the density and distribution of D1 receptors in humans. Recently, a new and superior PET radioligand for in vivo quantification of D1 receptors in extrastriatal regions has been developed. \[11C\]NNC-112 is a D1 radiotracer with high specific to nonspecific binding, making it suitable for imaging low density D1 receptors in extrastriatal regions such as the neocortex. Several studies in humans have confirmed the potential of this radiotracer, however, to date, dosimetry studies of \[11C\]NNC-112 in humans have not been performed. The specific objective of this protocol is to estimate radiation-absorbed doses of \[11C\]NNC-112 in human subjects. For this purpose, we propose to perform a kinetic whole body imaging study of \[11C\]NNC-112 in healthy human subjects. We hypothesize that the level of radiation-absorbed doses of \[11C\]NNC-112 in humans will be within limits, and consequently, we should be able to move to the next stage of our imaging research, where we will use this radioligand to measure the density and distribution of D1 receptors in Parkinson's disease.

Official TitleWhole Body Study of [11C]NNC-112 PET Imaging of Dopamine D1 Receptors 
NCT00088517
Principal SponsorNational Institute of Mental Health (NIMH)
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
10 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Criteria

INCLUSION CRITERIA All subjects must be healthy and aged 18-70 years. EXCLUSION CRITERIA Current psychiatric disease, substance abuse or severe systemic disease based on history and physical exam Laboratory tests with clinically significant abnormalities More than moderate hypertension Any prior participation in other research protocols within the past year that involve radiation, with the exception of plain radiography studies (i.e., chest x-rays). Pregnancy and Breast Feeding Positive HIV test

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
National Institute of Mental Health (NIMH)Bethesda, United StatesSee the location
CompletedOne Study Center