NCT04488419CompletedPhase 2/3
ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease
A Randomized, Placebo-Controlled, Double-Blind Study of ATH-1017 Treatment in Subjects With Mild to Moderate Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 4 Apr 2025
Brief summary (registry, in English)
This study is designed to evaluate safety and efficacy of fosgonimeton (ATH-1017) in the treatment of mild to moderate Alzheimer's disease with a randomized treatment duration of 26-weeks.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 554 (actual)
- First submitted
- 23 Jul 2020
- Start date
- 28 Sept 2020
- Primary completion date
- 15 Jul 2024
- Lead sponsor
- LeonaBio
- Diseases
- Alzheimer disease
- NCT number
- NCT04488419
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 554
- From 28 Sept 2020 to the primary completion date, 15 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of significant neurologic disease, other than AD, that may affect cognition, or concurrent with the onset of dementia
- Memantine in any form, combination or dosage within 4 weeks prior to Screening
- Acetylcholinesterase inhibitors in any dosage form
- The subject has received active amyloid or tau immunization (i.e., vaccination for Alzheimer's disease) at any time, or passive immunization (i.e., monoclonal antibodies for Alzheimer's disease) within 6 months of Screening
Other illness
- History of brain MRI scan indicative of any other significant abnormality
- Diagnosis of severe major depressive disorder even without psychotic features.
- Myocardial infarction or unstable angina within the last 6 months
- Clinically significant cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (note: pacemaker is acceptable)
- Subject has either hypertension or symptomatic hypotension
- Hepatic impairment with alanine aminotransferase or aspartate aminotransferase \> 2 times the upper limit of normal, or Child-Pugh class B and C
- Malignant tumor within 3 years before Screening
Lab values
- Chronic kidney disease with estimated glomerular filtration rate (eGFR) \<45 mL/min
Other
- Subject has atypical variant presentation of AD, if known from medical history, particularly non-amnestic AD
- Significant suicide risk
- History within 2 years of Screening, or current diagnosis of psychosis
- Clinically significant ECG abnormality at Screening
Who the study is looking for
- Age 55 to 85 years
- Mild-to-moderate AD dementia subjects, MMSE 14-24, CDR 1 or 2 at Screening
- Clinical diagnosis of dementia, due probably to AD, by Revised National Institute on Aging-Alzheimer's Association criteria (McKhann, 2011)
- Body mass index (BMI) of ≥ 18 and ≤ 35 kg/m2 at Screening
- Reliable and capable support person/caregiver
- Treatment-free (subjects not receiving acetylcholinesterase inhibitor \[AChEI\] treatment), defined as:
- Treatment-naïve, OR
- Subjects who received an AChEI in the past and discontinued at least 4 weeks prior to Screening
Age in the registry: 55 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Rochester-AD-CARE Program Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.