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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00407576
First received: December 2, 2006
Last updated: January 17, 2012
Last verified: November 2008
  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 Phase
Alzheimer's Disease
Healthy
Drug: [11C]MeS-IMPY
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: PET Imaging of Brain Amyloid Using [11C]MeS-IMPY

Resource links provided by NLM:


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

Estimated Enrollment: 30
Study Start Date: December 2006
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: [11C]MeS-IMPY
    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:

  1. Current or prior history of any alcohol or drug abuse.
  2. Severe systemic disease based on history and physical exam.
  3. Positive result on urine screen for illicit drugs.
  4. Laboratory tests with clinically significant abnormalities.
  5. Prior participation in other research protocols or clinical care in the last year such that radiation exposure would exceed the annual limits.
  6. Pregnancy or breast feeding.
  7. Claustrophobia.
  8. Presence of ferromagnetic metal in the body or heart pacemaker.
  9. History of brain disease other than Alzheimer's disease.
  10. Unable to lay on one's back for the PET/MRI scan.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

Publications:
Responsible Party: Robert B. Innis, M.D./National Institute of Mental Health, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00407576     History of Changes
Other Study ID Numbers: 070036, 07-M-0036
Study First Received: December 2, 2006
Last Updated: January 17, 2012
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

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 20, 2014