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)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Avid Radiopharmaceuticals

ClinicalTrials.gov Identifier:

NCT00702143

First received: June 19, 2008

Last updated: May 8, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 19, 2008

Last Updated Date

May 8, 2012

Start Date ^ICMJE

June 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Qualitative Amyloid Image Assessment [ Time Frame: 50-60 min after injection ] [ Designated as safety issue: No ]
Three readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.
Mean Cortical to Cerebellum SUVR [ Time Frame: 50-60 min after injection ] [ Designated as safety issue: No ]
Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.

Original Primary Outcome Measures ^ICMJE

Presence or absence of amyloid plaque on the 18F-AV-45 PET scan as determined by image readers blinded to all clinical information. Safety evaluations of subjects undergoing AV-45 PET scan. [ Time Frame: at close of enrollment for study ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00702143 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Proportion of Positive Florbetapir-PET Scans [ Time Frame: 50-60 min after injection ] [ Designated as safety issue: No ]

Three readers blinded to all clinical information classified florbetapir-PET images as either positive for amyloid or negative for amyloid. The majority read was used to determine the proportion of positive scans across the three groups.

Original Secondary Outcome Measures ^ICMJE

Determine rates of AV-45 PET scan positivity in AD, MCI and healthy normal subjects. [ Time Frame: at end of enrollment ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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)

Official Title ^ICMJE

An Open Label, Parallel Group, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-45 in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)

Brief Summary

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic

Condition ^ICMJE

Alzheimer's Disease
Mild Cognitive Impairment

Intervention ^ICMJE

Drug: florbetapir F 18

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

Other Names:

18F-AV-45
Amyvid
florbetapir

Study Arm (s)

Experimental: AD subjects
Intervention: Drug: florbetapir F 18
Experimental: MCI Subjects
MCI (mild cognitive impairment)

Intervention: Drug: florbetapir F 18
Experimental: Healthy controls
Intervention: Drug: florbetapir F 18

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

184

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria AD:

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

Inclusion Criteria MCI:

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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00702143

Other Study ID Numbers ^ICMJE

18F-AV-45-A05

Has Data Monitoring Committee

Responsible Party

Avid Radiopharmaceuticals

Study Sponsor ^ICMJE

Avid Radiopharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Chief Medical Officer

Avid Radiopharmaceuticals

Information Provided By

Avid Radiopharmaceuticals

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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