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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00702143
First received: June 19, 2008
Last updated: May 8, 2012
Last verified: May 2012

June 19, 2008
May 8, 2012
June 2008
December 2008   (final data collection date for primary outcome measure)
  • Qualitative Amyloid Image Assessment [ Time Frame: 50-60 min after injection ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00702143 on ClinicalTrials.gov Archive Site
Proportion of Positive Florbetapir-PET Scans [ Time Frame: 50-60 min after injection ] [ Designated as safety issue: No ]
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.
Determine rates of AV-45 PET scan positivity in AD, MCI and healthy normal subjects. [ Time Frame: at end of enrollment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)
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)

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).

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
  • Alzheimer's Disease
  • Mild Cognitive Impairment
Drug: florbetapir F 18
IV injection, 370MBq (10mCi), single dose
Other Names:
  • 18F-AV-45
  • Amyvid
  • florbetapir
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
184
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00702143
18F-AV-45-A05
No
Avid Radiopharmaceuticals
Avid Radiopharmaceuticals
Not Provided
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
Avid Radiopharmaceuticals
May 2012

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