A Study of Two Doses of 18F-AV-45 in Alzheimer's Disease and Healthy Volunteers

Study Overview
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Brief Summary
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This study will test two different doses of florbetapir F 18 to determine which dose is best to image amyloid plaques in the brains of Alzheimer's Disease (AD) patients using a positron emission tomography (PET) scanner.

Official Title
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An Open Label, Parallel Group, Dose Comparison of Safety and Imaging Characteristics of 111 and 370 MBq (3 and 10 mCi) of 18F-AV-45 for Brain Imaging of Amyloid in Healthy Volunteers and Patients With Alzheimer's Disease (AD)

Conditions
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Alzheimer Disease

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 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 (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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 111 MBq (3 mCi) AD Group<br>Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel | Drug: florbetapir F 18<br>* single dose IV injection<br>* Other names: florbetapir;|
| Experimental: 111 MBq (3 mCi) Control Group<br>Healthy controls who received 111MBq (3 mCi) of florbetapir F 18 | Drug: florbetapir F 18<br>* single dose IV injection<br>* Other names: florbetapir;|
| Experimental: 370 MBq (10 mCi) AD Group<br>Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18 | Drug: florbetapir F 18<br>* single dose IV injection<br>* Other names: florbetapir;|
| Experimental: 370 MBq (10 mCi) Control Group<br>Healthy controls who received 370MBq (10 mCi) of florbetapir F 18. | Drug: florbetapir F 18<br>* single dose IV injection<br>* Other names: florbetapir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Florbetapir-PET Scan Quality | Visual evaluation of image quality by nuclear medicine specialist blinded to dose and clinical information; reported on a 5-point scale (5=excellent and 1=poor). | 0-90 min after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0-90 min after 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