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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: florbetapir F 18


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: florbetapir F 18|IV injection, 111 or 370MBq (3 or 10mCi), single dose|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Scans acquired 30-40 min and 50-60 min after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Scans acquired 30-40 min and 50-60 min post-injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging