Phase III Study of the Correlation Between Florpiramine F18 PET Imaging and Amyloid Pathology in the Brain - Full Text View

Sponsored by:	Avid Radiopharmaceuticals
Information provided by:	Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00857415

Purpose

The study is designed to test the relationship between measurements of brain amyloid using florpiramine F 18 PET imaging and true levels of amyloid burden assessed by histology at autopsy.

There will be two primary analyses:

The first primary analysis will evaluate the correlation between the blinded readers' rating of amyloid burden on the PET scan and the cortical amyloid burden at autopsy.
The second primary analysis will evaluate the specificity of the blinded readers' rating of presence or absence of amyloid burden on the PET scan

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

Study Type:	Interventional
Study Design:	Diagnostic, Single Blind (Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase III Study of the Correlation Between Florpiramine F 18 (18F-AV-45) PET Imaging and Amyloid Pathology

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:

Blinded read of florpiramine F 18 PET images [ Time Frame: ~12 months, following enrollment of all subjects ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	December 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Autopsy population: Experimental Those individuals with end-of-life illnesses who undergo 18F-AV-45 PET brain amyloid imaging.	Drug: florpiramine F 18 Single i.v. bolus injection of 10 mCi (370MBq) 18F-AV-45 (florpiramine F 18)

Detailed Description:

For the autopsy population, approximately 150 subjects will be enrolled from various end-of-life (e.g. hospice / hospital / nursing home) and late-life (longitudinal studies of aging) populations. Enrollment will include subjects with various levels of cognitive status, ranging from cognitively normal through dementia. It is expected that amyloid burden in this elderly population will range from very low (normal aging) through moderate (e.g. cognitively normal subjects with asymptomatic amyloid deposits or MCI subjects with intermediate levels of amyloid deposits) to very high (subjects with AD).

Screening assessments may take place over several days and will include collection of demographic information, diagnostic interview, and safety assessments. At the time of screening, subjects or caregivers will be asked to provide consent for brain donation if they are not already enrolled in a brain donation program affiliated with this study, in addition to providing informed consent for the screening and imaging procedures in the study.

Subjects who qualify for the study will have a catheter placed for intravenous (i.v.) administration of florpiramine F 18. Subjects will receive a single i.v. bolus of 370 MBq (10 mCi) of florpiramine F 18 followed by brain PET imaging for 10 minutes duration, beginning approximately 50 minutes post-injection. Vital signs and safety labs will be obtained prior to the administration of florpiramine F 18 and at the completion of the imaging session. Adverse events will be continuously monitored during the imaging session. Subjects who experience an adverse event will not be discharged until the event has been resolved or stabilized.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Are males or females ≥18 years of age;
Have a projected life expectancy of ≤ 6 months as determined by the principal investigator (e.g. terminal medical condition) or are already enrolled in a longitudinal study of aging with an autopsy component;
Can tolerate a 10 minute PET scan; and
Give informed consent for study procedures and brain donation consistent with the legal requirements of the State in which they are enrolled and the State in which they die.

Exclusion Criteria:

Have primary brain tumor, known metastases to the brain, central nervous system (CNS) lymphoma;
Have any major, focal structural loss of brain matter;
Are aggressively being treated with life sustaining measures (e.g. currently on respirator; receiving high dose chemotherapy);
Have a clinically significant infectious disease, including Acquired Immune Deficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV) infection, previous positive test for hepatitis or HIV or Creutzfeldt-Jakob disease (CJD);
Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, secretase inhibitor);
Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session; or
Are females of childbearing potential who are pregnant or not using adequate contraception.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857415

Contacts

Contact: Michael J Pontecorvo, Ph.D.	215-966-6221	pontecorvo@avidrp.com
Contact: Christopher M Clark, M.D.	215-966-6123	clark@avidrp.com

Locations

United States, Arizona
Sun Health Research Institute	Recruiting
Sun City, Arizona, United States, 85372
Contact: Zoran Obradov, M.D. 623-875-6500 zoran.obradov@bannerhealth.com
Principal Investigator: Marwan Sabbagh, M.D.
Banner Alzheimer's Institute	Recruiting
Phoenix, Arizona, United States, 85006
Principal Investigator: Adam Fleisher, M.D.
United States, California
U of California, Irvine Medical Center	Recruiting
Irvine, California, United States, 92868
Principal Investigator: Steven G Potkin, MD
United States, Florida
Wien Center for Alzhiemer's Disease and Memory Disorders	Recruiting
Miami Beach, Florida, United States, 33140
Principal Investigator: Ranjan Duara, M.D.
United States, New York
Neurological Associates of Albany P.C.	Recruiting
Albany, New York, United States, 12208
Principal Investigator: Richard F Holub, M.D.
United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Edward Coleman, M.D.
United States, Ohio
Kettering Medical Center	Recruiting
Kettering, Ohio, United States, 45429
Principal Investigator: Martin Jacobs, M.D.

Sponsors and Collaborators

Avid Radiopharmaceuticals

More Information

No publications provided

Responsible Party:	Avid Radiopharmaceuticals ( Michael J. Pontecorvo, Ph.D., Vice President, Clinical Development )
Study ID Numbers:	18F-AV-45-A07
Study First Received:	March 5, 2009
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00857415 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Avid Radiopharmaceuticals:

florpiramine F 18 PET
amyloid imaging
Amyloid pathology in the brain

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 10, 2009