This trial is shared by:

A Clinical Trial to Learn More About an Investigational Treatment for Mild to Moderate Alzheimer’s Disease

NCT ID: NCT04488419

About the Condition/ Disease Overview:

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.

About the Trial:

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.

Estimated Enrollment
475 Participants
Phase
Phase 2/3

Eligibility Criteria

Participants must:

  • Be 55 to 85 years old.
  • Have a diagnosis of mild to moderate AD.
  • Have a regular caregiver who can help with attending trial visits and administering trial injections, as needed.

Participants must not:

  • Be currently taking a type of medication called an “acetylcholinesterase inhibitor” (i.e. donepezil) or memantine to treat their AD. Note: People who used to take these medications for AD but no longer take them are eligible to join this trial.
  • Have a history of neurologic disease (besides AD) that affects cognition.
  • Have a history of certain heart problems, such as multiple heart attacks in the last 5 years.
  • Be a woman of childbearing potential.
  • Be participating in another clinical trial of an investigational treatment.

See if you are eligible

What Will Happen 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:

  • Perform a physical exam
  • Ask you questions to evaluate your thinking and memory
  • Collect blood and urine samples
  • Refill your medication supply
  • Ask about your AD symptoms, how you are feeling, any new medications you are taking, and any new or worsening medical problems you might be having

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).

Where You Can Join

This trial is being conducted in sites located in the United States, with the goal of enrolling 475 patients in the study.

Location
Advanced Memory Research Institute of NJ
Status
Recruiting
Location
Neuropsychiatric Research Center of SW Florida
Status
Not Yet Recruiting
Location
Progressive Medical Research
Status
Recruiting
Location
SIU Medicine Neuroscience Institute (NSI)
Status
Recruiting
Location
Rush Alzheimer’s Disease Center, Rush University Medical Center
Status
Recruiting
Location
Keystone Clinical Studies, LLC
Status
Recruiting
Location
Atrium Health Department of Psychiatry
Status
Not Yet Recruiting
Location
Northern Light Acadia Hospital
Status
Recruiting
Location
Global Medical Institutes LLC; Princeton Medical Institute
Status
Not Yet Recruiting
Location
Neurological Associates of Albany, P.C.
Status
Not Yet Recruiting
Location
Activmed Practices & Research, Inc.
Status
Not Yet Recruiting
Location
AMC Research, LLC
Status
Not Yet Recruiting
Location
Neurology Diagnostics
Status
Recruiting
Location
Hackensack Meridian Hackensack University Medical Center
Status
Recruiting
Location
Rhode Island Mood & Memory Research Institute
Status
Recruiting
Location
Center for Cognitive Health
Status
Recruiting
Location
Neurology Center of North Orange County
Status
Recruiting
Location
ATP Clinical Research, Inc
Status
Recruiting
Location
Insight Clinical Trials, LLC
Status
Recruiting
Location
The Mile High Research Center / Colorado Neurology and Headache Center
Status
Recruiting
Location
Northwest Clinical Research Center
Status
Recruiting
Location
Neurology Clinical, P.C.
Status
Not Yet Recruiting
Location
Premiere Research Institute
Status
Recruiting
Location
Brain Matters Research
Status
Not Yet Recruiting
Location
iResearch Atlanta
Status
Recruiting
Location
Hawaiii Pacific Neuroscience, Memory Disorders Center & Alzheimer's Research
Status
Not Yet Recruiting
Location
JEM Research Institute
Status
Not Yet Recruiting
Location
Senior Adults Specialty Research
Status
Recruiting
Location
Xenoscience
Status
Recruiting
Location
Grayline Research Center
Status
Recruiting
Location
iResearch Savannah
Status
Recruiting
Location
Clinical Research Professionals
Status
Recruiting
Location
Banner Sun Health Research Institute
Status
Recruiting
Location
Summit Research Network
Status
Recruiting
Location
Indiana University School of Medicine, Department of Neurology
Status
Not Yet Recruiting
Location
University of Rochester- AD-CARE Program
Status
Recruiting
Location
Neurobehavorial Clinical Research
Status
Recruiting

See if you are eligible

Frequently Asked Questions (FAQs)