DIAN-TU-003: FAQs

The level of success was determined by several different factors. There is a measure called the primary outcome, which is the one thing that is used to determine whether the study is positive. The level of effect was pre-specified (documented prior to study results or data analysis) in a detailed statistical plan that was agreed upon, approved, and shared with our partners, including regulatory authorities and others. That is one of the main driving factors for measuring the drug(s)’ success; however, we also considered the other (secondary) outcome measures, which are the additional measures (tests) that were done during the trial. The amount of a drug’s effect, and any other information that we have from a trial, can be used to help determine whether a drug is beneficial or not.

The answer can be complicated and is not always a simple ‘success’ or ‘failure’. There is a lot of information and degrees of success. The size of the effect we see can influence the decisions about continuing with the Open Label Extension. In the case of both solanezumab and gantenerumab, the primary outcome was determined to be negative. However, there were some positive biomarker measures of disease activity and progression in the trial.

Open. Label. Extension, or OLE, is a phase of a study that occurs after the randomized (blinded) portion of the trial is completed if a drug is found to have the potential for benefit. Eligible trial participants take the active form of the drug without placebo. OLE allows active drug to be given to all participants at the same time and to follow them over time. OLE allows more scientific data to be collected and it offers the opportunity for participants who were previously on placebo to take the active drug. OLE enables a trial to continue to measure the drug’s effectiveness, how long that effect may last, and if the effect will be sustained (continued).

Contact your DIAN-TU site coordinator to request genetic counseling and disclosure of test results. You may receive genetic counseling remotely via phone and/or video chat (in-person counseling may also be requested, if available) and will not need to have a new blood draw. You will be able to receive results from genetic testing performed when you first enrolled in the trial. This process is only available for those eligible for the gantenerumab exploratory OLE. If you cannot reach your site coordinator, please contact the DIAN Expanded Registry at dianexr@wustl.edu.

No. There are a number of specific enrollment or “eligibility” criteria for a DIAN­ TU trial that must be met in order to qualify for participation. The DIAN-TU study team, in collaboration with our Pharma partners and the regulatory agencies in participating countries, such as the US Food and Drug Administration (FDA), design these criteria to make ensure the trials are as safe and effective as possible, as well as ensure the results of the trials will provide useful information as to whether the tested treatments impact AD.

Some DIAN-TU trials use placebo; these trials are called placebo-controlled. In order to determine the effectiveness and/or action of the study drug(s), the trials are designed to include a placebo which is an inactive preparation designed to resemble the test drug.

All participants are given consent forms to review prior to enrolling in a study; the list of potential side effects will be included in the consent form. Participants are encouraged to take as much time as needed to review the consent form. A member of the study team will be available to answer any questions prior to the first study visit. Once enrolled in a study, participants will be followed closely by the study nurse team. There may also be unknown side effects.

No. Even people on placebo may have side effects. A side effect is likely to be mild and may not be different from everyday type discomforts such as headache, fatigue, and nausea. Participants will be encouraged to report all side effects they experience so they can be documented. The study team will do everything possible to keep study team and participants blinded their mutation status, but it is possible that participation in a study could result in learning their mutation status, for example if having a side effect that is associated with the active drug.

Yes. The DIAN-TU has arranged to have visiting nurses available to complete study visits at participant homes and offices. The visiting nurses are available on weekdays, weekends, and also during evening hours, if necessary. The study teams will work with participants to schedule study visits to ensure all safety visits are completed as conveniently as possible. Visiting nurses are not site personnel but are contracted through a home health care company.

Participants may be able to remain on many prescription medications and enroll in a trial (this is determined by the specific trial criteria). For more detailed information, contact the DIAN expanded registry and a trial nurse will be able to provide more specific information.

No. You do not have to tell your primary care doctor or any other health professional that you are participating in a trial. It is completely your decision whether or not you choose to share this information with your doctor.

If you would like more information, please see the DIAN Expanded Registry section of this website or visit clinicaltrials.gov The trial currently has many active participating sites around the world.

You may not enroll in another intervention study while participating in a DIAN-TU clinical trial, as such participation could interfere with trial results. Examples of interventions include medication trials, studies in which your memory is tested regularly, or for which you have multiple PET scans. If you have further questions about potential participation in other studies, please contact your study coordinator.

No, you may not take anti-amyloid or anti-tau medications while enrolled in a DIAN-TU trial.  If you previously took these medications, you must wait approximately 6 months before joining a DIAN-TU trial.

Depending on the trial enrollment criteria and how informed your family members are regarding these criteria, it is possible that someone in your family could learn your status by knowing that you are a participant.  For instance, in the current DIAN-TU Secondary Prevention Trial (E2814), all participants must be mutation carriers.  If family members are aware of this criterion and know that you are enrolled in the study, they will know you are positive for the family mutation.