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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518374
• Other study ID #: 18F-AV-45-A14
• Status: Completed
• Phase: Phase 2
• Start date: December 2009
• Est. completion date: May 3, 2017

Study information

• Verified date: June 2018
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1768
• Est. completion date: May 3, 2017
• Est. primary completion date: May 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Subjects who meet all of the following criteria are eligible to enroll in this study:

1. Male or female subjects at least 18 years of age;

2. Subjects who sign an IRB approved informed consent prior to any study procedures. Where subjects are deemed incapable of informed consent, a legally authorized representative may provide consent, with the subject's documented assent; and

3. Subjects who in the opinion of the investigator can tolerate the PET scan procedures.

Subjects will be excluded from enrollment if they:

1. Have clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances as indicated by history, which in the opinion of the investigator might pose a potential safety risk to the subject;

2. Have current clinically significant cardiovascular disease. Clinically significant cardiovascular disease usually includes one or more of the following:

• cardiac surgery or myocardial infarction within the last 4 weeks;

• unstable angina;

• acute decompensated congestive heart failure or class IV heart failure;

• current significant cardiac arrhythmia or conduction disturbance, particularly those resulting in ventricular fibrillation, or causing syncope, or near syncope;

• uncontrolled high blood pressure; or

• QTc > 450 msec (by history or for patients with cardiac disease by screening evaluation in companion study)

Before enrolling a patient with any of the above conditions, the investigator must have performed a cardiac evaluation and obtain permission from the sponsor.

3. Have a history of drug or alcohol abuse within the last year, or prior prolonged history of abuse;

4. 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 (negative urine beta-hCG at the time of screening and negative urine beta-hCG on the day of imaging) or breastfeeding at screening. Women must avoid becoming pregnant, and must agree to refrain from sexual activity or to use reliable contraceptive methods for 24 hours following administration of Florbetapir F 18 Injection ( such as oral contraceptives for at least three months or an IUD for at least two months prior to the start of the screening visit, or various barrier methods, e.g., diaphragm or combination condom and spermicide);

5. Have a history of relevant severe drug allergy or hypersensitivity (Relevant severe drug allergies should be determined by the PI, and any questions about a subject's eligibility can be directed to Avid. If a subject has a history of severe drug allergies, it may be dangerous for them to participate in a study);

6. Are patients who have received an investigational medication under an FDA IND protocol within the last 30 days. Additionally, the time between the last dose of the previous experimental medication and enrollment (completion of screening assessments) must be at least equal to 5 times the terminal half-life of the previous experimental medication. Patients who have ever participated in an experimental study with an amyloid targeting therapy (e.g., immunotherapy, secretase inhibitor) may not be enrolled without prior sponsor approval unless it can be demonstrated that the patient received only placebo in the course of the trial;

7. Are patients with current clinically significant unstable medical comorbidities, as indicated by history or physical exam, that pose a potential safety risk to the subject.

8. Are patients who have received a radiopharmaceutical for imaging or therapy within the past 24 hours prior to the imaging session for this study. If another radiotracer is required in the companion protocol, patients may be able to receive a radiopharmaceutical for imaging or therapy within the 24 hours prior to the imaging session with prior sponsor approval and at the discretion of the investigator.; and

9. Are patients who, in the opinion of the investigator, are otherwise unsuitable for a study of this type.

If at the time of enrollment subjects do not meet all eligibility criteria, the subjects may still be enrolled if documentation is provided demonstrating that the subject will meet all criteria at the time of the first imaging procedure.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment
• Neurodegenerative Diseases

Intervention

Drug:
• Florbetapir F 18
370 MBq (10 mCi)

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	UTSW	Dallas	Texas
United States	UTSW	Dallas	Texas
United States	UTSW	Dallas	Texas
United States	UC Davis	Davis	California
United States	Duke University	Durham	North Carolina
United States	UC Irvine	Irvine	California
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	University of Kansas	Kansas City	Kansas
United States	University of Tennessee	Knoxville	Tennessee
United States	University of Southern California	Los Angeles	California
United States	Mt. Sinai Medical Center	Miami Beach	Florida
United States	Vanderbilt	Nashville	Tennessee
United States	UC Irvine	Orange	California
United States	Jefferson	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Banner Health	Phoenix	Arizona
United States	Butler Hospital	Providence	Rhode Island
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	UC San Francisco	San Francisco	California
United States	UC San Francisco Memory Center	San Francisco	California
United States	Banner Sun Health Research Institute	Sun City	Arizona
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Treatment-emergent Adverse Events Considered Related to Florbetapir Administration	Frequency of treatment-emergent adverse events considered related to florbetapir administration by the study investigator. Related events with a frequency > 0.2% are reported.; (note: all treatment-emergent adverse events, regardless of relatedness designation, are reported in "Adverse Events" section below)	48 hours