This trial is shared by:
NCT ID: NCT04488419
Alzheimer’s disease (AD) is the most common form of dementia. There is no cure for AD, and symptoms generally get worse with time.
Researchers are looking for better ways to treat AD. The investigational treatment being studied in this trial is a medication called ATH-1017, or fosgonimeton (trial drug). Fosgonimeton is designed to support overall brain network health by promoting protection and survival of nerve cells. This trial aims to evaluate the trial’s ability to improve cognition (a person’s ability to think and learn) and overall independence and function in people with mild to moderate AD.
This trial will include adults aged 55 to 85 years with mild to moderate AD who live in the United States. It is open to enrollment for people who are not currently taking acetylcholinesterase inhibitors or memantine to treat their AD.
People who join the trial will be randomly assigned to receive either the trial drug or a placebo (a placebo that looks exactly like the trial drug but contains no active ingredients). During the trial, neither the participants nor the trial site staff will know who is receiving the trial drug and who is receiving the placebo. Many trials are done this way because knowing what treatment a participant is receiving can affect the results. About 2/3 of the participants will receive the trial drug, while the remaining 1/3 will receive a placebo.
All of the participants will receive their assigned trial medication as a daily injection for 6 months.
The main goal of the trial is to learn how the cognition and function of participants receiving the trial drug versus placebo changes over six months. The other main goal is to learn more about any potential side effects medical issues the participants might have during the trial.
The costs of the trial site visits and trial drugs will be paid by the study sponsor, Athira Pharma.
Additionally, a study stipend may be available to compensate participants and their caregivers for the time and effort required to attend trial sites for visits, including meals, travel, etc.
We appreciate your interest in this trial.
If you are interested in joining this trial, you will need to visit a trial site. A trial doctor will explain what is required of you to participate in the trial. If you agree to join, the site doctors and other site staff will give you an examination and ask you questions about your AD and your medical history to make sure you are eligible to take part in the trial.
If you decide to join the trial, you will take your assigned treatment every day for 6 months. You will visit a clinical trial site 7 times during this 6-month period.
During trial site visits, the trial doctors will:
At the end of the trial, you will have 1 more visit to the trial site about a month after you take the last dose of your assigned trial treatment. Participants who finish the trial will have the option to continue in a longer-term (18-month) trial in which all of the participants will receive the trial drug.
In total, the participants will be asked to visit the trial site 9 times over a period of about 34 weeks (8-9 months).
This trial is being conducted in sites located in the United States, with the goal of enrolling 475 patients in the study.