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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-08-31

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.

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Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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111 MBq (3 mCi) AD Group

Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel

Group Type EXPERIMENTAL

florbetapir F 18

Intervention Type DRUG

single dose IV injection

111 MBq (3 mCi) Control Group

Healthy controls who received 111MBq (3 mCi) of florbetapir F 18

Group Type EXPERIMENTAL

florbetapir F 18

Intervention Type DRUG

single dose IV injection

370 MBq (10 mCi) AD Group

Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18

Group Type EXPERIMENTAL

florbetapir F 18

Intervention Type DRUG

single dose IV injection

370 MBq (10 mCi) Control Group

Healthy controls who received 370MBq (10 mCi) of florbetapir F 18.

Group Type EXPERIMENTAL

florbetapir F 18

Intervention Type DRUG

single dose IV injection

Interventions

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florbetapir F 18

single dose IV injection

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