Ability Of ([18F]-AV-45) PET Scan to Distinguish Alzheimer's Disease Subjects From Cognitively Normal Individuals - Full Text View

Sponsors and Collaborators:	Avid Radiopharmaceuticals American College of Radiology Imaging Network General Electric
Information provided by:	Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00855868

Purpose

This study will evaluate the performance characteristics of a novel [18F] amyloid detection ligand (18F]-AV-45) with respect to its ability to distinguish patients with clinically-diagnosed probable Alzheimer's disease from cognitively normal elderly subjects and to independently compare its diagnostic performance characteristics with the ability of [11C]PIB to correctly categorize the same subjects.

SPECIFIC HYPOTHESES

Individuals with a clinical diagnosis of probable Alzheimer's disease will have increased brain retention of [18F]-AV-45 compared to cognitively normal elderly individuals.
There will be no clinically meaningful difference in the amyloid retention performance characteristics of [18F]-AV-45 and [l1C]PIB.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: florpiramine F 18	Phase II

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Evaluation of the Ability of a Novel [18F] Amyloid Ligand ([18F]-AV-45) to Distinguish Patients With a Clinical Diagnosis of Alzheimer's Disease From Cognitively Normal Elderly Individuals

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Nuclear Scans

U.S. FDA Resources

Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:

Wilcoxon rank sum test of differences in SUVR for frontal cortex/cerebellum of the PET scan with [18F]-AV-45 for probable AD versus cognitively normal subjects. [ Time Frame: 28 d ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Ability of [18F]-AV-45 PET scan to distinguish AD from cognitively normal subjects versus [11C]-PIB PET scan [ Time Frame: 28 d ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	March 2009
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PET scan group: Experimental 15 cognitively normal subjects and 15 probable Alzheimer's disease subjects receive both [18F]-AV-45 and [11C]-PIB PET studies	Drug: florpiramine F 18 10 mCi (370 MBq), IV injection, single dose [18F]-AV-45 15 mCi (555 MBq), IV injection, single dose [11C]-PIB

Detailed Description:

15 patients with a clinical diagnosis of probable Alzheimer's disease and 15 cognitively normal elderly control subjects will receive both [18F]-AV-45 and [11C]PIB to compare the diagnostic performance characteristics of each amyloid ligand to distinguish AD from normal subjects. In addition to clinical diagnostic category, ligand retention will be evaluated with respect to measures of symptom severity and cerebrospinal fluid levels of amyloid and tau.

Eligibility

Ages Eligible for Study:	55 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Normal subjects: MMSE 27-30, CDR = 0, no symptoms of depression
Alzheimer's subjects: MMSE 18-26, CDR >=1.0, NINCDS-ADRDA probable AD, absence of abnormalities on MRI

Exclusion Criteria:

other neurological disease
evidence of MRI abnormality
psychiatric disorder
alcohol abuse
clinically significant lab abnormalities
residence in nursing facility
participation in clinical trial with experimental medication in past 1 month

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855868

Contacts

Contact: Steven E Arnold, M.D.	215-349-8225	SArnold@mail.med.upenn.edu
Contact: Andrew Newberg, M.D.	215-662-3092	Andrew.Newberg@uphs.upenn.edu

Locations

United States, Pennsylvania
Hospital of the University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Steven E Arnold, M.D.

Sponsors and Collaborators

Avid Radiopharmaceuticals

American College of Radiology Imaging Network

General Electric

Investigators

Study Chair:	Steven E Arnold, M.D.	PENN Memory Center, University of Pennsylvania
Study Chair:	Andrew Newberg, M.D.	University of Pennsylvania
Study Director:	Zheng Zhang, Ph.D.	Center for Statistical Sciences, Brown University
Study Director:	Constantine Gatsonis, Ph.D.	Biostatistics and Data Management Center, ACRIN

More Information

No publications provided

Responsible Party:	PENN Memory Center, University of Pennsylvania ( Steven E. Arnold, M.D. )
Study ID Numbers:	ACRIN PA 4003
Study First Received:	March 2, 2009
Last Updated:	March 17, 2009
ClinicalTrials.gov Identifier:	NCT00855868 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Avid Radiopharmaceuticals:

Amyloid imaging
Positron Emission Tomography
18F-AV-45
florpiramine F 18
Diagnostic imaging

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on September 11, 2009