DIAN Trials Unit Frequently Asked Questions


Are all mutations on the PS1, PS2 and APP genes eligible for participation in this research?

In order to participate in a trial, do I need to know my mutation status?

No. There must be a documented autosomal dominant mutation in the family, however, participants are not required to know or learn their personal genetic mutation status in order to participate in a trial. 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.

What is involved if I DO want to learn my mutation status?

Can anyone from a family with Dominantly Inherited Alzheimer’s disease (DIAD) participate in a DIAN-TU treatment trial?

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.

Do DIAN-TU trials use placebos?

Yes. 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.

Who decides whether participants get the active drug or placebo?

A computer system randomly assigns participants to 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 placebo for safety purposes and so that mutation status is not revealed to participants or study teams.

Are there possible side effects?

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 followed closely by a study nurse. There may also be unknown side effects.

If you have side effects, does that mean that you are mutation positive?

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 staff will do everything possible to keep study staff and participant’s 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.

Can study visits be scheduled around work hours?

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 research teams will work with participants to schedule study visits to ensure all safety visits are completed while as convenient as possible. Visiting nurses are not site personnel but are contracted through a home health care company.

Can participants taking medications for memory impairment (Namenda®, Aricept® , Razadyne®, Exelon®) remain on their medications during trial participation?

Yes. Participants may remain on many prescription medications and enroll in a trial.  For more detailed information, contact the DIAN expanded registry to be referred to a site (www.dianexr.org) and a trial nurse will be able to provide more specific information.

Do I have to tell my doctor that I am in a 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.

Where can I find more information about ongoing DIAN-TU trials and study sites?

If you would like more information, please see the DIAN Expanded Registry section of this website or visit clinicaltrials.gov. The trial is currently has many active participating sites around the world. We are currently working on developing sites in Italy, and Argentina.

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