Back to resultsEvaluation of PET Scan Timing Relative to AV-45 Injection Time
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
florbetapir F 18
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation
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.
Secondary Outcome Measures
Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01565356
Brief Title
Evaluation of PET Scan Timing Relative to AV-45 Injection Time
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avid Radiopharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
florbetapir F 18
Other Intervention Name(s)
18F-AV-45, Amyvid, florbetapir
Intervention Description
IV injection, 111 or 370MBq (3 or 10mCi), single dose
Primary Outcome Measure Information:
Title
Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation
Description
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.
Time Frame
Scans acquired 30-40 min and 50-60 min after injection
Secondary Outcome Measure Information:
Title
Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation
Description
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.
Time Frame
Scans acquired 30-40 min and 50-60 min post-injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Avid Radiopharmaceuticals
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Evaluation of PET Scan Timing Relative to AV-45 Injection Time
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