Open Label Study of ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease
- Conditions
- Alzheimer Disease
- Interventions
- Drug: ATH-1017
- Registration Number
- NCT04886063
- Lead Sponsor
- Athira Pharma
- Brief Summary
The objective of this study is to determine the safety and tolerability of fosgonimeton (ATH-1017) in subjects with mild to moderate Alzheimer's disease who completed the 26-week randomized treatment in Study ATH-1017-AD-0201 or Study ATH-1017-AD-0202.
- Detailed Description
This is a multicenter, seamless, open-label extension (OLEX) study of ATH-1017 treatment in subjects with a clinical diagnosis of mild to moderate Alzheimer's disease who completed 26 weeks treatment in the randomized, placebo-controlled, double-blind studies, ATH-1017-AD-0201 and ATH-1017-AD-0202. This OLEX study will provide additional, longer-term safety and tolerability information on ATH-1017 administration up to 48 months in subjects with mild to moderate Alzheimer's disease.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 423
- Subject has completed the Week 26 visit of either of the two blinded parent studies (ATH-1017-AD-0201 or ATH-1017-AD-0202).
- Reliable and capable support person/caregiver who is willing to accept responsibility for supervising the daily treatment or, if required, administering study drug.
- Subject capable of giving signed informed consent, or by a legally acceptable representative.
- Subjects must be in generally good health.
- Male subjects and their partners must agree to continue to use a double-barrier method of contraception during the study, including the follow-up period, unless the partner is not of childbearing potential.
-
Subject has experienced a serious adverse event during the parent study, which could present an increased safety risk during the open label extension.
-
New diagnosis of severe major depressive disorder even without psychotic features.
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Any subject with formalized delusions or hallucinations.
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Significant suicide risk.
-
Newly-diagnosed malignant tumor, except for the following conditions that are stable in the judgement of the investigator:
- Adequately treated squamous and basal cell carcinoma, or squamous and basal cell carcinoma in situ
- Prostate carcinoma in situ
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment ATH-1017 Daily subcutaneous (SC) injection of ATH-1017 - 40mg Dosage
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] 210 Weeks Description - To determine the safety and tolerability of ATH-1017 over an additional 206-week period in subjects with mild to moderate Alzheimer's disease (AD) who completed the 26-week randomized treatment in Study ATH-1017-AD-0201 or Study ATH-1017-AD-0202
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (73)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Xenoscience
🇺🇸Phoenix, Arizona, United States
Banner Sun Health Research Institute
🇺🇸Sun City, Arizona, United States
ATP Clinical Research, Inc
🇺🇸Costa Mesa, California, United States
Neurology Center of North Orange County
🇺🇸Fullerton, California, United States
Sunwise Clinical Research
🇺🇸Lafayette, California, United States
Healthy Brain Research Inc
🇺🇸Long Beach, California, United States
Denver Neurological
🇺🇸Denver, Colorado, United States
Mile High Research Center
🇺🇸Denver, Colorado, United States
JEM Research Institute
🇺🇸Atlantis, Florida, United States
Boynton Beach Medical Research Institute
🇺🇸Boynton Beach, Florida, United States
K2 Medical Research Winter Garden
🇺🇸Clermont, Florida, United States
Accel Clinical Research
🇺🇸Decatur, Georgia, United States
Brain Matters Research
🇺🇸Delray Beach, Florida, United States
Neuropsychiatric Research Center of SW Florida
🇺🇸Fort Myers, Florida, United States
Reliable Clinical Research LLC
🇺🇸Hialeah, Florida, United States
ClinCloud
🇺🇸Maitland, Florida, United States
Merrit Island Medical Research
🇺🇸Merritt Island, Florida, United States
Global Medical Institutes LLC
🇺🇸Miami, Florida, United States
Optimus U Corp
🇺🇸Miami, Florida, United States
Mart Medical Group Research
🇺🇸Miami, Florida, United States
Quantix Research
🇺🇸Miami, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Premiere Research Institute
🇺🇸West Palm Beach, Florida, United States
CenExel iResearch Atlanta
🇺🇸Decatur, Georgia, United States
CenExel
🇺🇸Savannah, Georgia, United States
Hawaii Pacific Neuroscience, Memory Disorders Center & Alzheimer's Research
🇺🇸Honolulu, Hawaii, United States
Rush Alzheimer's Disease Center, Rush University Medical Center
🇺🇸Chicago, Illinois, United States
SIU Medicine Neuroscience Institute (NSI)
🇺🇸Springfield, Illinois, United States
IU Health Neuroscience Center
🇺🇸Indianapolis, Indiana, United States
Northern Light Acadia Hospital
🇺🇸Bangor, Maine, United States
Headlands PharmaSite
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Charlestown, Massachusetts, United States
Activmed Practices & Research, Inc.
🇺🇸Lowell, Massachusetts, United States
Boston Center for Memory
🇺🇸Newton, Massachusetts, United States
Clinical Research Professionals
🇺🇸Chesterfield, Missouri, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
🇺🇸Las Vegas, Nevada, United States
Hackensack Meridian Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Global Medical Institutes LLC; Princeton Medical Institute
🇺🇸Princeton, New Jersey, United States
Advanced Memory Research Institute of NJ
🇺🇸Toms River, New Jersey, United States
Albuquerque Neuroscience Inc.
🇺🇸Albuquerque, New Mexico, United States
Neurological Associates of Albany
🇺🇸Albany, New York, United States
Integrative Clinical Trials
🇺🇸Brooklyn, New York, United States
Berman Clinical
🇺🇸New York, New York, United States
Manhattan Behavioral Medicine, PLLC
🇺🇸New York, New York, United States
University of Rochester-AD-CARE Program
🇺🇸Rochester, New York, United States
ERG Clinical Research
🇺🇸Staten Island, New York, United States
Atrium Health Department of Psychiatry
🇺🇸Charlotte, North Carolina, United States
Duke Neurology Research
🇺🇸Durham, North Carolina, United States
AMC Research, LLC
🇺🇸Matthews, North Carolina, United States
Insight Clinical Trials, LLC
🇺🇸Beachwood, Ohio, United States
Neurology Diagnostics
🇺🇸Dayton, Ohio, United States
Neurobehavioral Clinical Research
🇺🇸N. Canton, Ohio, United States
Summit Research Network Inc.
🇺🇸Portland, Oregon, United States
Center for Cognitive Health
🇺🇸Portland, Oregon, United States
Keystone Clinical Studies
🇺🇸Norristown, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
🇺🇸East Providence, Rhode Island, United States
Neurology Clinical, P.C.
🇺🇸Cordova, Tennessee, United States
Clinical Neuroscience Solutions Inc
🇺🇸Memphis, Tennessee, United States
Senior Adults Specialty Research
🇺🇸Austin, Texas, United States
Kerwin Memory Center
🇺🇸Dallas, Texas, United States
El Faro Health and Therapeutics
🇺🇸Rio Grande City, Texas, United States
Grayline Research Center
🇺🇸Wichita Falls, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Core Clinical Research
🇺🇸Everett, Washington, United States
Evergreen Health Research Program
🇺🇸Kirkland, Washington, United States
University of Washington
🇺🇸Seattle, Washington, United States
Northwest Neurological
🇺🇸Spokane, Washington, United States
Hammondcare Greenwich Hospital
🇦🇺Greenwich, New South Wales, Australia
St Vincent's Centre for Applied Medical Research, Translational Research Centre
🇦🇺Darlinghurst, New South Wales, Australia
KaRa MINDS
🇦🇺Macquarie Park, New South Wales, Australia
HammondCare
🇦🇺Malvern, Victoria, Australia
Australian Alzheimer's Research Organization
🇦🇺Nedlands, Western Australia, Australia