Alzheimer's Disease Education and Referral Center

Clinical Evaluation of Florbetapir F 18 (18F-AV-45)

Overall Status:

Recruiting

Brief Description:

This study is designed to standardize imaging studies using florbetapir F 18 PET to provide information on amyloid burden in subjects participating in other studies, such as longitudinal studies of aging and studies of biomarkers for neurodegenerative diseases.

Patient Qualifications:

Min Age	Max Age	Gender	Healthy Volunteers
18 Years	N/A	Both	Yes

Inclusion Criteria:

At least 18 years of age
Ability to tolerate the PET scan procedures

Exclusion Criteria:

Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine conditions
Clinically significant cardiovascular disease, such as cardiac surgery or myocardial infarction within the last 4 weeks, unstable angina, significant cardiac arrhythmia or conduction disturbance, uncontrolled high blood pressure
History of drug or alcohol abuse within the last year or prior prolonged history of abuse
Women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception; women of childbearing potential must not be pregnant or breastfeeding
History of relevant severe drug allergy or hypersensitivity, as determined by investigators
Taking of an investigational medication under an FDA IND protocol within the last 30 days
Unstable medical comorbidities that pose a potential safety risk to the subject
Radiopharmaceutical for imaging or therapy within the past 24 hours prior to the imaging session for this study unless the trial sponsor has approved it

Detailed Description:

None

Central Contact Information:

For more information about individual study sites, contact Avid Clinical Operations: call 1-215-298-0700 or e-mail clinicaloperations@avidrp.com.

Locations:

Map Marker	City	State	Zip Code	Status	Primary Contact
Geolocation is 33.4636012, -112.0535987	Phoenix	Arizona	85006	Completed	Name: Phone:
Geolocation is 33.4636012, -112.0535987	Phoenix	Arizona	85006	Recruiting	Name: Phone:
Geolocation is 33.612697, -112.280129	Sun City	Arizona	85351	Completed	Name: Phone:
Geolocation is 38.5449065, -121.7405167	Davis	California	95618	Recruiting	Name: Phone:
Geolocation is 33.6471239, -117.8421325	Irvine	California	92697	Completed	Name: Phone:
Geolocation is 34.0502898, -118.2117257	Los Angeles	California	90033	Recruiting	Name: Phone:
Geolocation is 33.78659, -117.8750976	Orange	California	92868	Recruiting	Name: Phone:
Geolocation is 37.7813454, -122.497668	San Francisco	California	94121	Recruiting	Name: Phone:
Geolocation is 37.7642093, -122.4571623	San Francisco	California	94143	Recruiting	Name: Phone:
Geolocation is 37.7813454, -122.497668	San Francisco	California	94121	Completed	Name: Phone:
Geolocation is 30.3476884, -81.7458845	Jacksonville	Florida	32254	Recruiting	Name: Phone:
Geolocation is 25.8176795, -80.1372757	Miami Beach	Florida	33140	Recruiting	Name: Phone:
Geolocation is 41.8925085, -87.6161696	Chicago	Illinois	60611	Recruiting	Name: Phone:
Geolocation is 39.06, -94.61	Kansas City	Kansas	66160	Recruiting	Name: Phone:
Geolocation is 39.2962372, -76.5928888	Baltimore	Maryland	21287	Completed	Name: Phone:
Geolocation is 39.2962372, -76.5928888	Baltimore	Maryland	21287	Recruiting	Name: Phone:
Geolocation is 42.3652917, -71.0646337	Boston	Massachusetts	02114	Recruiting	Name: Phone:
Geolocation is 32.3361632, -90.1565209	Jackson	Mississippi	39216	Recruiting	Name: Phone:
Geolocation is 38.6212468, -90.2526163	St. Louis	Missouri	63110	Recruiting	Name: Phone:
Geolocation is 36.0038131, -78.9387241	Durham	North Carolina	27710	Recruiting	Name: Phone:
Geolocation is 36.0937141, -80.3268812	Winston-Salem	North Carolina	27104	Active, not recruiting	Name: Phone:
Geolocation is 39.9559288, -75.1574567	Philadelphia	Pennsylvania	19107	Not yet recruiting	Name: Phone:
Geolocation is 41.8396817, -71.3883751	Providence	Rhode Island	02906	Recruiting	Name: Phone:
Geolocation is 35.9113041, -83.8685072	Knoxville	Tennessee	37920	Completed	Name: Phone:
Geolocation is 36.1426398, -86.8001068	Nashville	Tennessee	37232	Recruiting	Name: Phone:
Geolocation is 32.8296623, -96.8511814	Dallas	Texas	75235	Recruiting	Name: Phone:
Geolocation is 32.8798071, -96.7547522	Dallas	Texas	75231	Recruiting	Name: Phone:
Geolocation is 32.8113367, -96.8397899	Dallas	Texas	75390	Recruiting	Name: Phone:

Agency
Avid Radiopharmaceuticals

Facility Investigators:

Name	Role	Affiliation
Chief Medical Officer	Study Director	Avid Radiopharmaceuticals

Study Contact:

Name	Phone	Email
Avid Clinical Operations	215-298-0700	clinicaloperations@avidrp.com

Locations

ClinicalTrials.gov ID

NCT01518374 (follow link to view full record on ct.gov in new window)

Official Title:

Clinical Evaluation of Florbetapir F 18 (18F-AV-45)

Study Start Date:

December 2009

Study End Date:

December 2015

Enrollment:

600

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Clinical Evaluation of Florbetapir F 18 (18F-AV-45)

Clinical Evaluation of Florbetapir F 18 (18F-AV-45)