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A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral β-Amyloid When Compared With Postmortem Histopathology

IRB Number

13-733

ClinicalTrials.gov Identifier

NCT01886820

Trial Status

Open for Enrollment
Phase 3

Why is this study being done?

The purpose of this study is to evaluate the safety of [18F]NAV4694 and to see how well [18F]NAV4694 works in diagnosing Alzheimer’s disease. [18F]NAV4694 is a radioactive chemical that attaches to a protein called beta amyloid. Deposits of the beta amyloid protein in the brain (also called senile plaques) are purportedly the cause of Alzheimer’s disease, and these deposits are required for the pathological diagnosis of Alzheimer’s disease to be made.

Who is eligible to participate?

Patients who are making end of life preparations and are interested in having an image of their brain made and are willing to donate their brains after death.

What is involved?

Before You Begin the Study Your participation would include the following procedures and events if you choose to participate and sign this informed consent document. All of the listed procedures are for research purposes and are not part of your standard care. By signing this form you are agreeing to the study procedures listed below including an autopsy of your brain after you die. It is very important that your relatives are aware of your decision so that they can also have any questions answered. During the Study Screening Visit This visit may take up to four hours and will occur only once at the beginning of the study. This visit may occur over more than one day; it may require a second visit at another location. Your screening visit includes: • Interview about your medical history, infectious disease history, medications, education, demographic information (such as age, sex, race), and family medical history. • Neuro-cognitive testing which includes tests to assess your cognition (thinking and memory). • Physical examination (routine examination of your body). • Blood draw (about 10 mL or 3 teaspoons) from a vein in your arm for routine testing. • MRI (magnetic resonance imaging) of the brain (described below). If you had an MRI recently, it may not be necessary to repeat your MRI. Your MRI can also be performed on the day you receive the study drug and have your PET scan. You will have the option to schedule the screening visit procedures over two days, for example having the MRI scan done on the first day and the PET scan on the second day. If you are traveling from outside Springfield and it is most convenient for you and your study partner to stay overnight in Springfield, you will be reimbursed by the Center for Alzheimer’s disease for the cost of the lodging provided you obtain pre-approval for the lodging from the Study Coordinator, Barbara Cray Lokaitis and submit the hotel receipt to her. If you cannot travel comfortably in a private vehicle, you may be transported in a medical van, provided you obtain pre-approval for the transportation from the Study Coordinator, Barbara Cray Lokaitis. The Center for Alzheimer’s Disease will arrange and pay for the medical van. o MRI Scan - You will be assessed for the metal you have in and on your body (jewelry, glasses, dentures, underwire within a bra, pacemaker, bone plates and screws) in preparation for the scan. The metal will need to be removed and the metal inside your body will be checked to confirm that it is safe for you to have a scan. The MRI session will last about 45 minutes, during which you will be resting with your back on the scanner couch. The scanner couch will slide your entire body into the donut-shaped MRI scanner. It may appear that you are confined in a long, narrow tunnel. However, the inside of the scanner is well lit and well ventilated. Audio equipment allows you and the technologist performing the scan to communicate with each other. The MRI scanner produces a magnetic field and radio waves that pass through your body. At the same time, it records the radio waves that are given off from your head to create a picture of your brain. During the MRI scan, you will hear several loud noises: the hum of the scanner; loud, repetitive thumping noises each time radio waves in the scanner are turned on and off; and whirring and grating sounds. Your study doctor will be able to review and share the results of your MRI scan with you if you choose to know them. If you experience anxiety or agitation during an MRI scan, you will be offered your usual psychotropic medication to relax, if you already have one ordered on your medication schedule. If none is already scheduled, you will be offered small dosages of lorazepam (1 to 2 milligrams) by mouth, up to a maximum total dosage of 4 milligrams in 24 hours, before, during, or after the procedure, at the discretion of and approval of Dr Ala, your primary doctor, and your legally authorized representative. Study Drug Injection and PET Imaging Visits This visit may take up to 2 hours and will occur after the screening visit and again at one and two years later. Some of the events before the study drug is given may be performed in the weeks prior depending on what will be most accommodating for you and your study doctor. • Before the study drug is administered:  Interview about any changes in your health and medications.  Body weight  Vital signs, which include assessing your blood pressure and heart beat.  Urine pregnancy testing for women who are able to have children.  Placement of catheter (small flexible tube inserted into a vein in your arm from which blood will be collected and the study drug will be given).  Blood collection, about 24 mL or 5 teaspoons for routine testing and optional Apo E genomic testing (before the initial study drug injection and imaging only).  Injection of study drug into catheter.  The amount of the injection is very small, about 10 mL or 2 teaspoons.  Saline (salt water) flush of catheter. • After Study Drug Injection  Removal of the catheter and monitoring of the injection site in your arm.  Vital signs, which include assessing your blood pressure and heart beat.  Interview about any changes in your health.  PET imaging (described in detail below). o PET scan - You will be injected with the study drug and then you will rest lying flat on your back on the scanner couch. Your head will be positioned in the large, donut-shaped PET scanner. During this long imaging session (about 30 minutes), it is important for you to keep your body, especially your head, as still as possible. During the scan it will be important that you try to rest quietly with your eyes closed, keeping your head and the rest of your body as still as possible. PET scanners detect the radiation in the study drug to create a picture of your brain. Your study doctor will learn the results of your PET scan and will be able to share them with you once available. If you experience anxiety or agitation during a PET scan, you will be offered your usual psychotropic medication to relax, if you already have one ordered on your medication schedule. If none is already scheduled, you will be offered small dosages of lorazepam (1 to 2 milligrams) by mouth, up to a maximum total dosage of 4 milligrams in 24 hours, before, during, or after the procedure, at the discretion of and approval of Dr Ala, your primary doctor, and your legally authorized representative. Follow-up Visits These visits will take about 30 minutes on the day of or after each of your study drug injection and imaging (5-28 hours). These visits may be done at the clinic or at your place of residence by Dr. Ala or by nurse practitioner Young. • Physical examination (routine examination of your body). • Vital signs, which include assessing your blood pressure and heart beat. • Interview about any changes in your health and medications. Follow-up Telephone Calls These visits will take about 10 minutes. This visit will be completed by phone about a week after each of your study drug injections. Research staff will interview you about any changes in your health and medications. Three attempts will be made to contact you, if necessary.

How long is the study?

Up to 26 months

Who can I contact for additional information?

Barbara Cray Lokaitis 217-545-9737

Who is the Principal Investigator of this study?

Tom Ala, MD

Where is the trial located?

Springfield, Illinois