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A Phase II Trial of 18F-AV-45 Positron Emission Tomography (PET) Imaging in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)

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ClinicalTrials.gov Identifier: NCT00702143
Recruitment Status : Completed
First Posted : June 20, 2008
Results First Posted : May 3, 2012
Last Update Posted : May 10, 2012
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 19, 2008
First Posted Date  ICMJE June 20, 2008
Results First Submitted Date  ICMJE April 6, 2012
Results First Posted Date  ICMJE May 3, 2012
Last Update Posted Date May 10, 2012
Study Start Date  ICMJE June 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
  • Qualitative Amyloid Image Assessment [ Time Frame: 50-60 min after injection ]
    Three readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.
  • Mean Cortical to Cerebellum SUVR [ Time Frame: 50-60 min after injection ]
    Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2008)
Presence or absence of amyloid plaque on the 18F-AV-45 PET scan as determined by image readers blinded to all clinical information. Safety evaluations of subjects undergoing AV-45 PET scan. [ Time Frame: at close of enrollment for study ]
Change History Complete list of historical versions of study NCT00702143 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2012)
Proportion of Positive Florbetapir-PET Scans [ Time Frame: 50-60 min after injection ]
Three readers blinded to all clinical information classified florbetapir-PET images as either positive for amyloid or negative for amyloid. The majority read was used to determine the proportion of positive scans across the three groups.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2008)
Determine rates of AV-45 PET scan positivity in AD, MCI and healthy normal subjects. [ Time Frame: at end of enrollment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Trial of 18F-AV-45 Positron Emission Tomography (PET) Imaging in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)
Official Title  ICMJE An Open Label, Parallel Group, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-45 in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)
Brief Summary Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Alzheimer's Disease
  • Mild Cognitive Impairment
Intervention  ICMJE Drug: florbetapir F 18
IV injection, 370MBq (10mCi), single dose
Other Names:
  • 18F-AV-45
  • Amyvid
  • florbetapir
Study Arms  ICMJE
  • Experimental: AD subjects
    Intervention: Drug: florbetapir F 18
  • Experimental: MCI Subjects
    MCI (mild cognitive impairment)
    Intervention: Drug: florbetapir F 18
  • Experimental: Healthy controls
    Intervention: Drug: florbetapir F 18
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2011)
184
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2008)
200
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria AD:

  • Male or female >=50 years of age
  • Meet National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS) criteria for probable AD with MMSE score of 10-24

Inclusion Criteria MCI:

  • Male or female >=50 years of age
  • Have a Clinical Dementia Rating (CDR) of 0.5
  • MMSE >24

Normal subjects:

  • Male or female >=50 years of age
  • MMSE >=29
  • Normal on psychometric test battery at screening
  • Provide informed consent

Exclusion Criteria:

  • Have a history or current diagnosis of other neurologic disease
  • Have had or currently have a diagnosis of other neurodegenerative disease
  • Have participated in experimental therapy targeted to amyloid plaque
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00702143
Other Study ID Numbers  ICMJE 18F-AV-45-A05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avid Radiopharmaceuticals
Study Sponsor  ICMJE Avid Radiopharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
PRS Account Avid Radiopharmaceuticals
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP