NCT00407576

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

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

December 1, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2008

Completed
Last Updated

July 2, 2017

Status Verified

November 7, 2008

Enrollment Period

1.9 years

First QC Date

December 2, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

Alzheimer's DiseasePositron Emission TomographyBrainNeurochemistryBeta-Amyloid PlaquesPETMeS-IMPYAlzheimer DiseaseADDementiaHealthy VolunteerHV

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

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)

  • 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. doi: 10.1523/JNEUROSCI.21-24-j0004.2001.

    PMID: 11734604BACKGROUND
  • Burger C, Buck A. Requirements and implementation of a flexible kinetic modeling tool. J Nucl Med. 1997 Nov;38(11):1818-23.

    PMID: 9374364BACKGROUND
  • 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. doi: 10.1097/01.WCB.0000038000.34930.4E.

    PMID: 12368666BACKGROUND

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Interventions

N,N-dimethyl-4-(6-(methylthio)imidazo(1,2-a)pyridine-2-yl)aniline

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

December 2, 2006

First Posted

December 5, 2006

Study Start

December 1, 2006

Primary Completion

November 7, 2008

Last Updated

July 2, 2017

Record last verified: 2008-11-07

Locations