What to Expect
The ACT-AD Trial is No Longer Enrolling
Participating in ACT-AD
The ACT-AD trial is seeking to enroll approximately up to 75 participants with mild to moderate Alzheimer’s disease in the United States and Australia. Qualified participants will be randomly assigned to receive fosgonimeton or placebo. Participation in the study takes about eight months including approximately six months of treatment duration. During the treatment period, you or your caregiver will administer daily subcutaneous injections using the provided prefilled syringes (i.e. small injection under the skin that you can take at home; the injection is prepared and ready for administration).
Upon completion of the ACT-AD trial, interested participants are eligible to enroll in the Open Label Extension study of fosgonimeton. This study ensures participants will receive the active drug.
What is Involved in the Trials?
The study team will go over the detailed study information and criteria. You and your caregiver will be asked to sign consent forms if you decide to participate in the study.
You and your caregiver will participate in a screening visit to determine your eligibility for study participation, including answering questions to evaluate your memory conditions and collecting blood samples.
Study Drug Assignment
If you meet all of the eligibility in the screening visit, you will return to the site for the next visit. You will receive another memory test to confirm your eligibility before receiving your first administration of the study drug, via a random assignment. A randomized study is designed to maintain scientific integrity, so neither you nor your clinical team will know the assignment. Since there are two dose groups of fosgonimeton and one group of placebo for evaluation, approximately 2 out of 3 participants will receive active treatment.
During the study duration, including approximately six months of treatment and one month of safety follow-up, participants will return to the clinical site for scheduled visits every two to six weeks. These visits will include tests to evaluate your memory conditions and will also include blood draws to evaluate safety. Your caregiver will also be asked to provide inputs about your memory conditions, daily activities, and mood.
In addition to memory and safety evaluations, the ACT-AD study includes a brain function test called event-related potential (ERP). ERP is a type of electroencephalogram (EEG) assessment, a non-invasive procedure. You will wear a cap with embedded electrodes to measure brain function as related to memory and treatment response to the study drug.