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

Tracking Information
First Received Date ^ICMJE	December 2, 2006
Last Updated Date	November 8, 2008
Start Date ^ICMJE	December 2006
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE (submitted: October 19, 2007)	Determine if admin of anti-p53 TCR-engineered peripheral blood lymphocytes and IL-2 to pts following nonmyeloablative but lymphoid depleting preparative regimen will result in clinical tumor regression in pts with metastatic cancer overexpressing p53.
Change History	Complete list of historical versions of study NCT00407576 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE (submitted: October 19, 2007)	Determine the in vivo survival of TCR gene-engineered cells.@@@Determine the toxicity profile of this treatment regimen.

Descriptive Information
Brief Title ^ICMJE	PET Imaging of Brain Amyloid Using [11C]MeS-IMPY
Official Title ^ICMJE	PET Imaging of Brain Amyloid Using [11C]MeS-IMPY
Brief Summary	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.
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.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	Alzheimer's Disease Healthy
Intervention ^ICMJE	Drug: [11C]MeS-IMPY
Study Arms / Comparison Groups
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	30
Completion Date	November 2008
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00407576
Responsible Party
Study ID Numbers ^ICMJE	070036, 07-M-0036
Study Sponsor ^ICMJE	National Institute of Mental Health (NIMH)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	November 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP