DIAN-TU-003: Frequently Asked Questions

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 obtained in clinical trials and varying degrees of success. As an example, a primary outcome can be determined to be negative. However, there may be some positive biomarker measures of disease activity and progression in the trial.

Not everyone in a particular family may qualify for a DIAN-TU trial, as 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 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 Alzheimer’s disease (AD). All participants in the Amyloid Removal Trial (ART) must have previously participated in the DIAN-TU-001 gantenerumab OLE period.

Open Label Extension, or OLE, is a period (portion) of a study that occurs after the randomized (blinded, placebo) portion of the trial is completed if a drug is found to have the potential for benefit. Eligible trial participants taking part in an OLE period take the active form of the drug and no participants receive a placebo. OLE periods allow active drug to be given to all participants at the same time and to follow them over time. OLE periods allow more scientific data to be collected, and it offers the opportunity for participants who were previously on placebo to take the active drug. OLE periods enable a trial to continue to measure a drug’s effectiveness, how long that effect may last, and if the effect will be sustained (continued); it also allows for the continued collection of safety data.

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 study drug being tested. The Amyloid Removal Trial (ART) does NOT use a placebo, as all participants receive an active drug.

Yes, the trial will cover the cost of ApoE genetic testing to help better assess your risk for ARIA (Amyloid-Related Imaging Abnormalities), a possible side effect from taking anti-amyloid monoclonal antibody treatments such as lecanemab.  ApoE testing will be offered separately by your site study team during the consenting process and/or is available at any time throughout the study.  Clinical testing will be provided outside of the trial so you will need to submit a new blood, saliva, or buccal (cheek) swab sample for testing.  Your study coordinator will arrange for the testing, and the neurologist at your site will disclose the results to you and explain their significance.

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.

Yes. The DIAN-TU has arranged to have visiting nurses available to complete study visits at participant homes and offices in most countries. 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 to be referred to a site (www.dian.wustl.edu) and a trial study coordinator will be able to provide more specific information.

 No, you may not take approved or investigational anti-amyloid or anti-tau medications while enrolled in a DIAN-TU trial. Examples of such medication are Leqembi® (lecanemab-irmb) and Kisunla™ (donanemab-azbt). If you previously took these medications, you must wait approximately 6 months before joining a DIAN-TU trial.

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.

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.

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 you are a participant. For instance, in the Amlyoid Removal Trial, 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.

If you would like more information, please visit clinicaltrials.gov or further explore this website. The trial currently has many active participating sites around the world.