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)

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Alzheimer's Disease, Mild Cognitive Impairment

Intervention / Treatment
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* Drug: florbetapir F 18


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AD subjects<br> | Drug: florbetapir F 18<br>* IV injection, 370MBq (10mCi), single dose<br>* Other names: florbetapir;|
| Experimental: MCI Subjects<br>MCI (mild cognitive impairment) | Drug: florbetapir F 18<br>* IV injection, 370MBq (10mCi), single dose<br>* Other names: florbetapir;|
| Experimental: Healthy controls<br> | Drug: florbetapir F 18<br>* IV injection, 370MBq (10mCi), single dose<br>* Other names: florbetapir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative Amyloid Image Assessment | 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. | 50-60 min after injection | 
| Mean Cortical to Cerebellum SUVR | Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum. | 50-60 min after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Positive Florbetapir-PET Scans | 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. | 50-60 min after injection |