Evaluation of PET Scan Timing Relative to AV-45 Injection Time

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01565356
First received: March 26, 2012
Last updated: May 3, 2012
Last verified: May 2012

March 26, 2012
May 3, 2012
March 2010
May 2010   (final data collection date for primary outcome measure)
Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation [ Time Frame: Scans acquired 30-40 min and 50-60 min after injection ] [ Designated as safety issue: No ]
Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported as amyloid positive or amyloid negative. Results show the percentage of agreement between the majority read of 30-40 min scan and the majority read of the 50-60 min scan.
Qualitative evaluation of brain PET images [ Time Frame: Scan acquired 30-60 min after injection ] [ Designated as safety issue: No ]
Majority visual read of 3 independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection; results reported as amyloid positive or amyloid negative
Complete list of historical versions of study NCT01565356 on ClinicalTrials.gov Archive Site
Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation [ Time Frame: Scans acquired 30-40 min and 50-60 min post-injection ] [ Designated as safety issue: No ]
Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported the results using a 5-point scale (0=no amyloid; 4=high levels of amyloid deposition). Results are reported as a weighted kappa statistic.
  • Semi-quantitative read of brain PET images [ Time Frame: Scan acquired 30-60 min post-injection ] [ Designated as safety issue: No ]
    Median visual semi-quantitative of 3 independent readers blinded to clinical information. Results for overall cortical amyloid burden recorded using a 5-point scale, ranging from 0 (no amyloid) to 4 (high levels of amyloid deposition)
  • Mean cortical SUVR [ Time Frame: Scan acquired 30-60 minutes after injection ] [ Designated as safety issue: No ]
    Standardized uptake values (SUV) are determined by an automated process that extracts estimates of tracer retention on a PET scan from prespecified standard volumes of interest. Mean cortical SUV ratio (SUVR) is the ratio of the average SUV of 6 cortical brain regions to the SUV of the cerebellum reference region.
Not Provided
Not Provided
 
Evaluation of PET Scan Timing Relative to AV-45 Injection Time
Comparison of PET Images Acquired at 30 Min and 50 Min Post Injection of 18F-AV-45 in Healthy Volunteers and Alzheimer's Disease Patients

This study will re-read 10-minute positron emission tomography (PET) scans acquired in previous clinical studies of AV-45 at 30 and 50 minutes after injection and compare the results.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Alzheimer's Disease
Drug: florbetapir F 18
IV injection, 111 or 370MBq (3 or 10mCi), single dose
Other Names:
  • 18F-AV-45
  • Amyvid
  • florbetapir
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
May 2010
May 2010   (final data collection date for primary outcome measure)

Eligibility for subjects scans to be used in this study is determined by subject's eligibility/enrollment in Study A01(NCT01565291) or A03(NCT01565330).

Inclusion Criteria (AD group):

  • Greater than 50 years of age
  • Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
  • Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score ranging from 10 to 24, boundaries included, at screening
  • History of cognitive decline gradual in onset and progressive over a period of at least 6 months

Inclusion Criteria (A01[NCT01565291] healthy volunteer group):

  • 50 years of age, inclusive

    • MMSE of 29 or greater

Inclusion Criteria (A03[NCT01565330] healthy volunteer group):

  • 35 to 55 years of age, inclusive
  • MMSE of 29 or greater

Exclusion Criteria (both groups):

  • Neurodegenerative disorders other than AD, including, but not limited to Parkinson's disease, Pick's disease, fronto-temporal dementia, Huntington's chorea, Down syndrome, Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy
  • Diagnosis of other dementing / neurodegenerative disease
  • Diagnosis of mixed dementia
  • Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation
  • Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria
  • Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology)
  • Clinically significant psychiatric disease
  • History of epilepsy or convulsions
  • Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
  • Current clinically significant cardiovascular disease
  • Received investigational medication within the last 30 days
Both
35 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01565356
18F-AV-45-A06
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