Groundbreaking scientific advances in the present and the past were possible only because of participation of volunteers, both healthy and those with an illness, in clinical research. Clinical research requires complex and rigorous testing in collaboration with communities that are affected by the disease. As research opens new doors to finding ways to diagnose, prevent, treat, or cure disease and disability, clinical trial participation is essential to help us find the answers.
Many different types of people take part in clinical trials. Some are healthy, while others may have illnesses. Research procedures with healthy volunteers are designed to develop new knowledge, not to provide direct benefit to those taking part. Healthy volunteers have always played an important role in research.
Informed consent is the process of providing you with key information about a research study before you decide whether to accept the offer to take part. The process of informed consent continues throughout the study. To help you decide whether to take part, members of the research team explain the details of the study.
If you do not understand English, a translator or interpreter may be provided. The informed consent document also explains risks and potential benefits. You can then decide whether to sign the document. Taking part in a clinical trial is voluntary and you can leave the study at any time.
Clinical trials are approved and monitored by an Institutional Review Board IRB to ensure that the risks are reduced and are outweighed by potential benefits. Data extraction and risk of bias rating were independently assessed. Eleven trials were eligible for meta-analysis.
These trials assessed effects of OLPs on back pain, cancer-related fatigue, attention deficit hyperactivity disorder, allergic rhinitis, major depression, irritable bowel syndrome and menopausal hot flushes. But opting out of some of these cookies may affect your browsing experience.
Necessary Necessary. Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information. Non-necessary Non-necessary. Additional information will be needed during the OLE that will help to determine the potential benefit of gantenerumab. Because of this, it is important to keep the OLE period of the trial as close to the original, blinded part of the trial as possible.
If participants and site investigators find out who was on active drug or placebo during the blinded period of the trial, it could influence performance on important cognitive tests during the OLE period. If you participated in the solanezumab arm, you will be able to enroll in the gantenerumab OLE. If you prefer, you may also decline participation in the OLE and instead, if you are eligible, enroll in the Cognitive Run-In CRI period of the next new drug study, which will later add a drug that targets the tau protein.
Individuals who participated in the blinded period of the trial may be eligible to continue in the OLE. You cannot join OLE if you did not participate in either the gantenerumab or solanezumab blinded drug arms. Yes, since placebo will not be offered, only participants who know they are positive for the genetic mutation, and therefore have potential to benefit from the treatment, will be able to enroll into OLE to receive gantenerumab.
Because only the active drug will be administered, there is no benefit for mutation negative participants to continue with study procedures. The design of the next tau studies have not been finalized. Several are planned, and it is likely they will be tau-only trials that will not allow concurrent experimental therapy such as gantenerumab. Thus, it is unlikely that you could participate in both the OLE and some future studies to be planned, including tau trials.
However, the investigators and companies are interested in combination therapy, and will be exploring the possibility of a tau therapy combination that might be designed to include gantenerumab OLE participants. Can you please explain what this means in terms of helping delay symptoms? Neurofilament light NfL is released from nerve cells in the brain called neurons when they are damaged, and NfL can be measured in the CSF and blood. In a variety of diseases which damage the brain, increased NfL is a marker of ongoing brain damage.
NfL increases goes up in DIAD participants, and the treated group in our blinded study showed less increase than those on placebo suggesting that there is less brain damage.
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