N/A Completed N=24 Randomized Triple-blind Basic Science

Evaluation of [11C]Cimbi-36 as an Agonist PET Radioligand for Imaging of 5-HT2A Receptors

Healthy

Source: ClinicalTrials.gov NCT01778686 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2024

Primary outcomePrimary: Percent Change in Neocortical [11C]Cimbi-36 BPND From Baseline to Intervention in Each Arm — 7.4; 0.6; 3.8 percent change

Summary

The purpose of this project was to introduce the recently developed positron emission tomography (PET) tracer [11C]Cimbi-36 for use in clinical studies and to investigate the ability of the tracer to quantify the 5-HT2A receptor in the human brain. As a receptor agonist, [11C]Cimbi-36 binding will provide a more functional picture of 5-HT2A receptors, while this binding is thought to be correlated to brain serotonin levels. Both measurement of signaling through the 5-HT2A receptor and measurement of serotonin levels in vivo would have great scientific relevance for significant diseases such as depression and schizophrenia.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Neocortical [11C]Cimbi-36 BPND From Baseline to Intervention in Each Arm	7.4; 0.6; 3.8	—

Eligibility Criteria

Inclusion Criteria

Age > 18 years
Generally healthy

Exclusion Criteria

primary psychiatric disorder
current or previous neurological disease, severe somatic disease or taking medications that can influence the results.
non-fluent in danish or severe visual or hearing impairment
current or previous learning difficulties
pregnancy or lactating
contraindications for magnetic resonance scanning
alcohol or drug abuse
allergy to any of the used medications
participation in studies with radioactivity (>10 mSv) within the last year or significant occupational exposure to radioactivity.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01778686). 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. Informational only — not medical advice.