DIAN-TU-002: Frequently Asked Questions

Not everyone in a particular family may qualify for a DIAN-TU trial, as there are a number of specific enrollment or “eligibility” criteria 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).

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.

Some DIAN-TU trials use a 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.

In placebo-controlled trials, a computer system randomly assigns participants to an active drug or placebo. The assignment to drug or placebo is double-blinded, which means neither the participant nor any member of the study team will know whether an individual is receiving study medication or placebo. All mutation negative participants are assigned to a placebo for safety purposes and so that mutation status is not revealed to participants or study teams.

There must be a documented dominantly inherited mutation in the family, however, participants may not be required to know or learn their personal genetic mutation status in order to participate in a trial. Each trial will outline the specific requirements regarding mutation status knowledge. If a person knows their mutation status is positive, they may be eligible for a trial. Individuals that know their mutation status is negative, meaning they do not have the mutation that causes AD in their family, are not eligible to participate in a trial.

It is possible that you could enroll into future drug arms of the DIAN-TU trial without learning your genetic status; however, this possibility will be determined as each new drug arm is launched. Given clinical availability of effective, anti-amyloid therapies in some countries, future DIAN-TU drug trials may be offered in combination with these or other therapies, which may require you to learn your genetic status.

If you are part of a family with an eligible genetic mutation, you may request genetic counseling and testing by joining the DIAN Expanded Registry to assess which DIAN study is best for you. Once this assessment is complete, you may receive a referral to virtual or in-person genetic counseling for an initial appointment. The genetic counselor will request a sample collection kit be sent to you to collect a saliva or buccal (check) swab sample, with return instructions.  Once testing is complete, the genetic counselor will schedule a results disclosure appointment with you and provide a written report of your results.  You may choose to share results with the Expanded Registry to securely keep in your registry file for future study referrals.

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 remternetug.  ApoE testing will be included as part of the initial testing in the trial, and if you agree to receive the results, the neurologist at your site will disclose the results to you and explain their significance.

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 DIAN-TU Primary Prevention trial, while a participant can enroll into Stage 1 without knowing their genetic status, they must learn their genetic status to participate in Stage 2. 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.

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, as even people on placebo may have side effects. Participants will be encouraged to report all side effects or health changes they experience so they can be documented. The study team will do everything possible to keep study team and participants blinded to their mutation status, but it is possible that participation in a study could result in learning or even assuming they’ve learned their mutation status; for example, having a side effect that is associated with the active study drug.

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 and a trial nurse 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 medications 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.

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, and even a negative result can be considered a successful trial when run correctly and important information is learned. The size of the effect we see can influence the decisions about continuing with the Open Label Extension.

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 an 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.

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