PET Imaging of Brain Amyloid Using [11C]MeS-IMPY - Full Text View

Purpose

Alzheimer's disease is associated with accumulation in the brain of a protein called amyloid. The purpose of this study is to test the ability of a research drug to measure amyloid in brain using positron emission tomography (PET) and a research drug called [11C]MeS-IMPY.

Condition	Intervention
Alzheimer's Disease Healthy	Drug: [11C]MeS-IMPY

Genetics Home Reference related topics:

Alzheimer disease

MedlinePlus related topics:

Alzheimer's Disease Dementia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Official Title:	PET Imaging of Brain Amyloid Using [11C]MeS-IMPY

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	30
Study Start Date:	December 2006
Estimated Study Completion Date:	November 2008

Intervention Details:

N/A

Detailed Description:

Alzheimer's disease (AD) is characterized pathologically by the presence of beta-amyloid plaques in brain. A substantial body of research indicates that the presence of increased beta -amyloid peptide is neurotoxic, and may initiate further pathology observed in AD including neurofibrillary tangles, synaptic loss and dysfunction, and neurodegeneration. There are multiple binding sites available on beta-amyloid plaques. Three clearly identified sites are Congo-red type, Thioflavin-T type, and FDDNP type. Radioligands currently under development using positron emission tomography (PET) for studying beta-amyloid in clinical research or drug development are based on Thioflavin-T site, such as [11C]PIB and [11C]SB-13. Though variously effective, these radioligands have one or more drawbacks with respect to measuring relative regional beta-amyloid densities. Therefore, we have recently developed [11C]MeS-IMPY as an alternative radioligand for imaging beta-amyloid, which will allow a more accurate quantification of amyloid plaques in AD brain. In the current protocol, we wish to evaluate [11C]MeS-IMPY in both healthy subjects and AD patients to determine the kinetics of brain imaging beta-amyloid plaques in AD patients.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

INCLUSION CRITERIA:

Healthy control subjects aged 18-90 years and AD patients aged 50-90, with history/physical exam, ECG, and laboratory tests.

Informed Consent.

AD Patients: Mini-Mental State Examination (score greater than or equal to 10).

AD Patients: Meet NINCDS-ADRDA criteria for probable AD.

EXCLUSION CRITERIA:

Current or prior history of any alcohol or drug abuse.
Severe systemic disease based on history and physical exam.
Positive result on urine screen for illicit drugs.
Laboratory tests with clinically significant abnormalities.
Prior participation in other research protocols or clinical care in the last year such that radiation exposure would exceed the annual limits.
Pregnancy or breast feeding.
Claustrophobia.
Presence of ferromagnetic metal in the body or heart pacemaker.
History of brain disease other than Alzheimer's disease.
Unable to lay on one's back for the PET/MRI scan.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407576

Locations


United States, Maryland
	National Institutes of Health Clinical Center, 9000 Rockville Pike
	Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

More Information

Publications:

Agdeppa ED, Kepe V, Liu J, Flores-Torres S, Satyamurthy N, Petric A, Cole GM, Small GW, Huang SC, Barrio JR. Binding characteristics of radiofluorinated 6-dialkylamino-2-naphthylethylidene derivatives as positron emission tomography imaging probes for beta-amyloid plaques in Alzheimer's disease. J Neurosci. 2001 Dec 15;21(24):RC189.

Burger C, Buck A. Requirements and implementation of a flexible kinetic modeling tool. J Nucl Med. 1997 Nov;38(11):1818-23.

Ichise M, Toyama H, Innis RB, Carson RE. Strategies to improve neuroreceptor parameter estimation by linear regression analysis. J Cereb Blood Flow Metab. 2002 Oct;22(10):1271-81.

Study ID Numbers:	070036, 07-M-0036
First Received:	December 2, 2006
Last Updated:	November 8, 2008
ClinicalTrials.gov Identifier:	NCT00407576
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Alzheimer's Disease

Positron Emission Tomography

Brain

Neurochemistry

Beta-Amyloid Plaques

PET

MeS-IMPY

Alzheimer Disease

AD

Dementia

Healthy Volunteer

HV

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders

Mental Disorders

Alzheimer Disease

Central Nervous System Diseases

Healthy

Neurodegenerative Diseases

Brain Diseases

Dementia

2,3-dihydro-1H-imidazo(1,2-b)pyrazole

Cognition Disorders

Delirium

Additional relevant MeSH terms:

Antineoplastic Agents

Therapeutic Uses

Nervous System Diseases

Tauopathies

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 19, 2008

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00407576