What to Expect
Participating in the SHAPE Trial
The SHAPE Trial is seeking to enroll approximately up to 75 participants with Parkinson’s Disease Dementia or Dementia with Lewy Bodies in the United States. 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).
What is Involved in the Trials?
Informed Consent
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.
Screening Visit
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.
Pre-Baseline Visit
If you meet all of the eligibility criteria in the screening visit, you will return to the site for a pre-baseline visit. During the pre-baseline visit, you will participate in a brain function assessment called Event-Related Potential described further in the “Brain Assessments” section.
Study Drug Assignment
If you are eligible, no more than 10 days after your pre-baseline visit you will return to the site for the next visit. You will receive additional memory tests and brain assessments prior to your first administration of the study drug via random assignment. Please note that you will be participating in brain assessments before and after the administration of study drug. 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.
Study Visits
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 four to six weeks. These visits will include tests to evaluate your memory conditions, brain assessments 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.
Brain Assessments
In addition to memory and safety evaluations, the Shape Trial 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 functions as related to memory and treatment response to the study drug.