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 Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-12-31

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).

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Detailed Description

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Conditions

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Alzheimer's Disease Mild Cognitive Impairment

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

Group Type EXPERIMENTAL

florbetapir F 18

Intervention Type DRUG

IV injection, 370MBq (10mCi), single dose

MCI Subjects

MCI (mild cognitive impairment)

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18F-AV-45 Amyvid florbetapir

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes