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

Study Overview
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Brief Summary
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A preliminary study to test how florbetapir F 18 (18F-AV-45) acts in the brains and bodies of healthy elderly people and patients with Alzheimer's Disease (AD) by using a positron emission tomography (PET) scanner.

Official Title
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A Preliminary Evaluation of the Amyloid Binding Properties, Pharmacokinetics and Safety of 18F-AV-45 in Healthy Elderly Volunteers and Patients With Alzheimer's Disease

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): 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 exam (MMSE) score ranging from 10 to 24, boundaries included, at screening History of cognitive decline had been gradual in onset and progressive over a period of at least 6 months Inclusion Criteria (healthy volunteer group): No evidence of significant cognitive impairment by history and psychometric testing MMSE of 29 or higher Exclusion Criteria (both groups): Neurodegenerative disorders other than AD 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: 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects With AD<br>Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination (MMSE) from 10 to 24) | Drug: florbetapir F 18<br>* IV injection, 370MBq (10mCi), single dose<br>* Other names: florbetapir;|
| Experimental: Healthy Elderly Subjects<br>Cognitively normal with MMSE of 29 or higher; age 50 years or older | 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 |
| --- | --- | --- |
| 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 cerebellum gray matter. Total scan length was 200 min. | 50-60 min after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precuneus to Cerebellum SUVR | Ratio of uptake in the precuneus to uptake in the cerebellum. | 50-60 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