Title: A phase II/III, double-blinded, randomized placebo-controlled study to assess the safety and efficacy of ATH-1017 (fosgonimeton) in treating mild to moderate Alzheimer’s disease (AD)
Study Director: Hans Moebius, MD, PhD, from Athira Pharma
Responsible Party: Athira Pharma
Description: Researchers are conducting a phase 3 trial to evaluate the safety and efficacy of subcutaneously administered fosgonimeton by comparing high dose, low dose, and placebo treatment groups in patients with mild to moderate Alzheimer disease (AD). Patients are randomly assigned to these 3 treatment groups in a 1:1:1 ratio.
The primary outcome measure of this study is the overall treatment effect of fosgonimeton. Secondary outcomes include evaluating patient cognition scores, Clinical Global Impression of Change scores, and Activities of Daily Living scores.
To be eligible for this study, patients must be aged 55 to 85, diagnosed with mild to moderate AD, have a caregiver, cannot be receiving acetylcholinesterase inhibitor treatment (or has not been treated at least 4 weeks prior to screening), and have a body mass index (BMO) between 18 to 35 kg/m2. For a complete list of eligibility criteria, please see the reference.
This study is sponsored by Athira Pharma.
This article originally appeared on Neurology Advisor
ClinicalTrials.gov. ATH-1017 for treatment of mild to moderate Alzheimer’s disease (LIFT-AD). NCT04488419. Accessed August 2, 2023.