You may experience side effects while in the study and you will be watched carefully for any side effects that may arise. However, doctors don’t know all of the side effects that may happen. Side effects may be mild or very serious. In some cases, side effects can be serious, long lasting, or may never go away.
You should talk to your study doctor about any side effects you experience while taking part in the study.
- Questionnaires and Assessments Risks:
- There are no physical risks from answering questionnaires. Questionnaires and assessments may cause some individuals to become upset, frustrated, bored or tired. You are free to decline to answer any question that you do not want to answer. You are free to stop the interview at any time, take a break, skip a question, and/or ask the study staff if you have any questions
- MRI Scan Risks:
- Because the MRI machine acts like a large magnet, it could move iron-containing objects in the MRI room during your examination, which in the process could possibly harm you. Precautions have been taken to prevent such an event from happening; loose metal objects, like pocket knives or key chains, are not allowed in the MRI room. If you have a piece of metal in your body, such as a fragment in your eye, aneurysm clips, ear implants, spinal nerve simulators, or a pacemaker, you will not be allowed into the MRI room and cannot have an MRI.
- Having an MRI may mean some added discomfort for you. In particular, you may be bothered by feelings of claustrophobia and by the loud banging noise during the study. Temporary hearing loss has been reported from this loud noise. This is why you will be asked to wear earplugs and headphones. If at any time you indicate any discomfort and do not wish to proceed for any reason, the scan will be terminated immediately
- Because the risks to a fetus from MRI are unknown, pregnant women must not participate in this study.
- There is a possibility that the MRI examination will result in the unexpected discovery of an abnormal condition. This may be distressing for participants. In the event that an abnormality is found, we will notify the subject’s physician. If the subject does not have a physician, Dr. Weiner will contact the subject directly.
- PET Scan Risks:
- The primary risk of PET scans is radiation exposure. Radiation Risks: This research study involves exposure to radiation from a PET/CT scan. This radiation exposure is not necessary for your medical care and is for research purposes only. The additional amount of radiation that you will receive as a result of participating in this study will be a maximum of approximately 7 mSv, which is slightly more than 2 times the yearly natural background of radiation in the US, which is 3 mSv (a mSv, or milliSievert, is a measurement of radiation). This amount of radiation may involve a low risk of cancer. If you are pregnant or breast feeding, you SHOULD NOT participate in this study. If you have any questions regarding the use of radiation or the risks involved, please consult the physician conducting the study.
- Other risks associated with PET scanning include fatigue and discomfort at having to remain in the scanner for up to 20 minutes, and the discomfort and possible bruising associated with intravenous injections.
- To minimize these risks, this study uses the lowest possible dose of radioactivity needed to obtain a clear image. All IV catheters are placed by medical professionals with extensive training and experience. If you experience anxiety or discomfort at any time while in the PET scanner, you can communicate via intercom with the technician at any time during the scan.
- The most common side effects reported in studies using florbetapir lasted only a short time and included: headache, muscle or bone pain, increased blood pressure, nausea, fatigue, injection site reaction (bleeding, irritation, pain), anxiety, back pain, claustrophobia (fear of being in closed or narrow spaces), dizziness, feeling cold, insomnia (inability to sleep) and neck pain. Less common side effects reported were: infusion site rash, altered taste in the mouth, itchiness, rash (hives), and flushing, but participants never experienced all of these side effects simultaneously.
- Loss of Confidentiality Risks:
- All de-identified data collected in this study will be shared broadly. There is a slight risk that there could be a breach in the security of research database systems resulting in the access of identifiable information. Safeguards are in place to minimize this risk