NCT01268020

Evaluation of [18F] FMH3 and PET as a Marker of Histamine-3 Receptor Activity in Subjects With AD Compared w/ HC

An Exploratory, Open-label, Non-randomized Phase 0 Study to Evaluate [18F]-FMH3 by Positron Emission Tomography (PET) for Quantization of the Receptor Histamine-3 in Human

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Institute for Neurodegenerative Disorders · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The underlying goal of this study is to assess \[18F\]-FMH3 PET imaging as a tool to evaluate the activity of the H3 receptor in the brain of Alzheimer Disease (AD) research participants

Detailed description

Approximately 10 subjects with Alzheimer disease (AD) and 8 healthy control (HC)subjects will be recruited to participate in this study. All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations. Subjects will be asked to undergo a bolus injection of \[18F\]-FMH3. Subjects will undergo serial PET imaging scans and plasma sampling for measurement of \[18F\]-FMH3 in plasma (both protein bound and free) over a period of up to 8 hours. The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, \[18F\]-FMH3. At least 2 weeks following the initial imaging visit, subjects may be asked to return for a second injection and scanning procedure to evaluate the reproducibility of the imaging measure using this procedure. Subjects may decline to participate in the second scan.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	[18F]-FMH3	Subjects will be injected with up to 5 mCi and not to exceed 5.5mCi (not \>10% of 5 mCi limit) or 2 ug of \[18F\]-FMH3, whichever is greatest.

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2010-12-29
• Last updated: 2013-11-11

Locations

1 site across 1 country: United States