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

Avid Radiopharmaceuticals41 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Alzheimer's Disease

Interventions

florbetapir F 18DRUG

IV injection, 111 or 370MBq (3 or 10mCi), single dose

Eligibility

Sex: ALLMin age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Scans acquired 30-40 min and 50-60 min after injection

Secondary Outcomes

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.

Time frame: Scans acquired 30-40 min and 50-60 min post-injection

Data from ClinicalTrials.gov

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