The ‘TRAILBLAZER-ALZ 3’ trial will evaluate whether treatment with donanemab can slow the clincial progression of Alzheimer’s diseases in participants.
Donanemab is an investigational antibody that targets a modified form of beta amyloid called N3pG. Phase 2 data, published in March, showed the monoclonal antibody ‘met its primary endpoint and showed significant slowing of decline’ in cognitive and daily function in patients with early symptomatic Alzheimer’s disease.
Enrolment in the Phase 3 trial is expected to begin later this year, with Lilly remaining the sole sponsor of the trial.
Formed in 2006, the Banner Alzheimer’s Institute's aims are to find effective Alzheimer’s disease prevention therapies and forge new models of collaboration in biomedical research. As part of the new collaboration announced today, Banner will contribute its expertise in prevention trials and support enrolment of trial participants with and without the e4 type of the apolipoprotein E (APOE4) gene through the Alzheimer's Prevention Registry's GeneMatch program.
Notably, the collaboration will introduce a more virtual approach to the evaluation of Alzheimer's prevention therapies.
"This study will provide a great deal of flexibility in how and where participants complete study visits," Dr. Eric Reiman, Banner Alzheimer's Institute executive director and one of the study's lead principle investigators, told this publication.
"In a traditional study, participants go to a study site to conduct all study activities. In TRAILBLAZER-ALZ 3, participants have the option to conduct activities in a location of their choice (that is, using electronic tablets and video calls) that do not require in-person interactions, such as informed consent; collection of medical history and adverse events; cognitive and functional assessments; etc.
"For in-person activities, such as infusions, blood draws, imaging, and physical exams, participants may go to a traditional site or another “satellite” facility that provides these services. These facilities may include infusion centers, mobile research units, imaging centers, etc.
"Given that a large portion of study activities may be completed in the location of their choice, such as their own home, study partners do not even need to be in the same location as their study participant(s). We believe this approach increases opportunity for study participation for people who do not live near major medical centers that typically conduct clinical trials.
"We also anticipate that this flexibility could increase clinical trial participation for underrepresented populations."
Recruitment is one of the biggest obstacles researchers face for all Alzheimer’s-focused studies and this is only exacerbated in Alzheimer’s prevention trials.
"It is challenging to raise awareness that there are prevention trial opportunities, since most people don’t think of joining a clinical trial while they are healthy," said Dr Reiman. "It is hard to find enough people willing to enter screening and who meet a trial’s specific eligibility criteria for enrollment."
"These tools help engage, inform, and identify cognitively unimpaired people who may be interested in research. They also help diversify study participation, which is crucial to enroll participants who are representative of the population and people who may ultimately receive the treatment if a trial is successful and the treatment approved.
"The TRAILBLAZER-ALZ3 3 trial will capitalize on these programs and the use of a widely deployable blood test for Alzheimer’s disease (Lilly’s plasma p-tau217 assay) to reach out to participants where they live, and it will make it easier for them to participate in studies close to their home and in more convenient settings. We hope that this approach will help galvanize the enrollment of interested and eligible research participants in this prevention trial and set a precedent for other trials so that we can find effective Alzheimer’s prevention therapies as soon as possible."