PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease

Summary

Participation Requirements

Description

Study Description: This pilot/exploratory study will examine whether cyclooxygenase 1 (COX-1) and COX-2 are elevated in the brains of individuals with neurodegenerative brain disease compared to healthy volunteers. Objectives: Primary Objective: To determine whether COX-1 and/or COX-2 is elevated in...

Study Description: This pilot/exploratory study will examine whether cyclooxygenase 1 (COX-1) and COX-2 are elevated in the brains of individuals with neurodegenerative brain disease compared to healthy volunteers. Objectives: Primary Objective: To determine whether COX-1 and/or COX-2 is elevated in the brains of individuals with neurodegenerative brain disease compared to healthy volunteers. Secondary Objective: To determine retest variability for each radioligand and the possibility of avoiding arterial sampling by using a bolus + constant infusion (B/I) paradigm. Endpoints: Primary Endpoint: Measurement of COX-1 and COX-2 density in brain after PET scans with [11C]PS13 and [ 11C]MC1, respectively. Secondary endpoint: To measure whole-brain distribution volume (VT) of COX-1 and COX-2 calculated using B/I. Study Population: Five groups will be studied: 1) Alzheimer s disease (AD), 2) frontotemporal dementia (FTD), 3) other dementias, 4) Amyotrophic Lateral Sclerosis (ALS), and 5) healthy volunteers. The number of participants per group will be up to 16 for the patient groups and up to 25 for the healthy volunteers. Participants may be male or female. They must be (Bullet)18 years old, but most are expected to be 60 to 80 years old. Participants may be recruited from anywhere, but most are expected to come from the Washington DC metropolitan area. Patients must be in good medical health but may be unable to provide informed consent because of cognitive impairment. In that case, the Legally Appointed Representative (LAR) must provide consent, and the patient must provide assent. Phase: 1 Description of Sites/Facilities Enrolling Participants: Screening and PET imaging will be performed at the NIH Clinical Center. Description of Study Intervention: Participants will be intravenously injected with 20 mCi of one or both of the radioligands: [11C]MC1 and [11 C]PS13. Participants will also have a radial artery catheter(s) inserted to measure the concentration of radioligand (either one insertion (if both scans are performed on the same day) or two insertions (if the scans are performed on two different days). Participants will also have a brain MRI to provide anatomic orientation for the PET scans. Study Duration: 36 months Participant Duration: One week to four months, depending on the patient s availability and access to MRI and PET cameras.

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