A Study of 18F-AV-45 in Alzheimer's Disease (AD) and Healthy Volunteers

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-04-30

Brief Summary

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This study will test if two AV-45 PET scans up to 4 weeks apart in AD subjects and healthy volunteers provide the same results. The study will also test two different AV-45 injection methods in a small subgroup of enrolled AD subjects (slow vs. fast bolus group).

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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AD Subjects

Two bolus IV injections followed by brain PET scan up to 4 weeks apart

Group Type EXPERIMENTAL

florbetapir F 18

Intervention Type DRUG

IV injection, 370MBq (10mCi)

AD Subjects: Slow vs. Fast Bolus

Two bolus IV injections followed by a brain PET scan up to 4 weeks apart.

The first injection given as a rapid bolus (\< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).

Group Type EXPERIMENTAL

florbetapir F 18

Intervention Type DRUG

IV injection, 370MBq (10mCi)

Healthy controls

Healthy male or female subjects; 35-55 years old. Two bolus IV injections followed by brain PET scan up to 4 weeks apart

Group Type EXPERIMENTAL

florbetapir F 18

Intervention Type DRUG

IV injection, 370MBq (10mCi)

Interventions

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florbetapir F 18

IV injection, 370MBq (10mCi)

Intervention Type DRUG

Other Intervention Names

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18F-AV-45 Amyvid florbetapir

Eligibility Criteria

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Inclusion Criteria

* 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

* 35 to 55 years of age, inclusive
* MMSE of 29 or greater

Exclusion Criteria

* 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

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes