NCT00044200

Brief Summary

This study uses positron emission tomography (PET) to examine brain function and signaling involving phospholipids, and to see how signaling is related to blood flow. Much of the brain is composed of fatty molecules called phospholipids. These molecules are involved in the way brain cells signal each other to direct brain function. Brain disease may change phospholipids and disturb brain structure and signaling. Studies of brain phospholipid composition and metabolism may help clarify how the brain works in healthy people or stops working effectively in disease states. Healthy volunteers between 18 and 45 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests. Participants undergo magnetic resonance imaging (MRI) and PET scanning as follows: MRI MRI uses a magnetic field and radio waves to produce images of body tissues and organs. For this procedure, the subject lies on a table that is moved into a metal cylinder (the scanner) and wears earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. Scanning time varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes. Subjects may be asked to lie still for up to 30 minutes at a time. PET For the PET scan, a catheter (thin plastic tube) is inserted into an artery in the subject's wrist or elbow crease to collect blood samples during the procedure, and a second catheter is placed in a vein in the opposite arm to inject radioactive tracers. The subject lies on the scanner bed, wearing a special facemask and goggles. The mask helps hold the head still during the scans, and the goggles either block all light or administer bright flashing lights. Radioactive water is injected into the vein, followed by a 1-minute PET scan to measure brain blood flow. This is repeated three more times. Then, a radioactive fatty acid is injected into the vein, followed by a 1-hour PET scan to measure brain phospholipid metabolism. This is repeated once. The images of blood flow and phospholipid metabolism in the different regions of the brain under the conditions of darkness and during visual stimulation provide information on how and where the brain responds to visual stimulation. The entire procedure takes about 3 hours.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2000

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2002

Completed
12.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2015

Completed
Last Updated

July 5, 2018

Status Verified

June 12, 2015

First QC Date

August 21, 2002

Last Update Submit

July 3, 2018

Conditions

Keywords

Phospholipase A2Arachidonic AcidBlood FlowCouplingNeurotransmissionPETSignal TransductionActivationBrain[15O]H20

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All subjects must have normal values on screening measures to be in the study.
  • Age between 18 and 45 years.

You may not qualify if:

  • Past or current medical condition that would interfere with brain function- history of alcoholism; psychiatric or neurological illness; head trauma with loss of consciousness; history of exposure to central nervous system toxin; history of central nervous system infection; metabolic, endocrine, connective tissue disease; hypertension or other cardiovascular disorder; abnormal renal, liver or pulmonary function; blood or coagulation disease; malignancy; psychopharmacological treatment; neurodegenerative or neurodevelopmental disorder; stroke; epilepsy; sensitivity to flashing lights. Subjects requiring regular medication.
  • Subjects demonstrated by drug screening to have taken controlled substance.
  • For female subjects, pregnancy or current breast-feeding (nursing).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Arai T, Wakabayashi S, Channing MA, Dunn BB, Der MG, Bell JM, Herscovitch P, Eckelman WC, Rapoport SI, Chang MC. Incorporation of [1-carbon-11]palmitate in monkey brain using PET. J Nucl Med. 1995 Dec;36(12):2261-7.

    PMID: 8523117BACKGROUND
  • Axelrod J. Phospholipase A2 and G proteins. Trends Neurosci. 1995 Feb;18(2):64-5. doi: 10.1016/0166-2236(95)93873-v. No abstract available.

    PMID: 7537411BACKGROUND
  • Axelrod J. Receptor-mediated activation of phospholipase A2 and arachidonic acid release in signal transduction. Biochem Soc Trans. 1990 Aug;18(4):503-7. doi: 10.1042/bst0180503. No abstract available.

    PMID: 2177403BACKGROUND

Study Officials

  • Stanley I Rapoport, M.D.

    National Institute on Aging (NIA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

August 21, 2002

First Posted

August 22, 2002

Study Start

January 10, 2000

Study Completion

June 12, 2015

Last Updated

July 5, 2018

Record last verified: 2015-06-12

Locations