Back to resultsOpen Label Study of ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease
Primary Purpose
Alzheimer Disease
Status
Enrolling by invitation
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ATH-1017
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's, Dementia, ATH-1017, Open Label
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Any subject with formalized delusions or hallucinations.
- 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
Sites / Locations
- Xenoscience
- Banner Sun Health Research Institute
- ATP Clinical Research, Inc
- Neurology Center of North Orange County
- Mile High Research Center
- JEM Research Institute
- Brain Matters Research
- Neuropsychiatric Research Center of SW Florida
- ClinCloud
- Merrit Island Medical Research
- Progressive Medical Research
- Premiere Research Institute
- iResearch Atlanta, LLC
- iResearch Savannah
- Hawaii Pacific Neuroscience, Memory Disorders Center & Alzheimer's Research
- Rush Alzheimer's Disease Center, Rush University Medical Center
- SIU Medicine Neuroscience Institute (NSI)
- IU Health Neuroscience Center
- Massachusetts General Hospital
- Activmed Practices & Research, Inc.
- Clinical Research Professionals
- Cleveland Clinic Lou Ruvo Center for Brain Health
- Hackensack Meridian Hackensack University Medical Center
- Global Medical Institutes LLC; Princeton Medical Institute
- Advanced Memory Research Institute of NJ
- Albuquerque Neuroscience Inc.
- Neurological Associates of Albany
- Manhattan Behavioral Medicine, PLLC
- University of Rochester-AD-CARE Program
- Atrium Health Department of Psychiatry
- Duke Neurology Research
- AMC Research, LLC
- Insight Clinical Trials, LLC
- Neurology Diagnostics
- Neurobehavioral Clinical Research
- Summit Research Network Inc.
- Center for Cognitive Health
- Keystone Clinical Studies
- Rhode Island Mood & Memory Research Institute
- Neurology Clinical, P.C.
- Senior Adults Specialty Research
- Grayline Research Center
- Northwest Clinical Research Center
- Evergreen Health Research Program
- University of Washington
- Northwest Neurological
- St Vincent's Centre for Applied Medical Research, Translational Research Centre
- Hammondcare Greenwich Hospital
- KaRa MINDS
- HammondCare
- Australian Alzheimer's Research Organization
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Daily subcutaneous (SC) injection of ATH-1017 - 40mg Dosage
Outcomes
Primary Outcome Measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description - To determine the safety and tolerability of ATH-1017 over an additional 130-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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04886063
Brief Title
Open Label Study of ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease
Official Title
Open-Label Extension of Studies ATH-1017-AD-0201 and ATH-1017-AD-0202 in Subjects With Mild to Moderate Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
February 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Athira Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 30 months in subjects with mild to moderate Alzheimer's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer's, Dementia, ATH-1017, Open Label
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Open label extension
Masking
None (Open Label)
Allocation
N/A
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Daily subcutaneous (SC) injection of ATH-1017 - 40mg Dosage
Intervention Type
Drug
Intervention Name(s)
ATH-1017
Intervention Description
Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Description - To determine the safety and tolerability of ATH-1017 over an additional 130-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
Time Frame
130 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Any subject with formalized delusions or hallucinations.
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
Facility Information:
Facility Name
Xenoscience
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Banner Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
ATP Clinical Research, Inc
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Neurology Center of North Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Mile High Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
JEM Research Institute
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Neuropsychiatric Research Center of SW Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
ClinCloud
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Merrit Island Medical Research
City
Merritt Island
State/Province
Florida
ZIP/Postal Code
32952
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
iResearch Atlanta, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
iResearch Savannah
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Hawaii Pacific Neuroscience, Memory Disorders Center & Alzheimer's Research
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Rush Alzheimer's Disease Center, Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
SIU Medicine Neuroscience Institute (NSI)
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
IU Health Neuroscience Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Massachusetts General Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Facility Name
Activmed Practices & Research, Inc.
City
Lowell
State/Province
Massachusetts
ZIP/Postal Code
01852
Country
United States
Facility Name
Clinical Research Professionals
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Facility Name
Cleveland Clinic Lou Ruvo Center for Brain Health
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Hackensack Meridian Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Global Medical Institutes LLC; Princeton Medical Institute
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Advanced Memory Research Institute of NJ
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Albuquerque Neuroscience Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Neurological Associates of Albany
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Manhattan Behavioral Medicine, PLLC
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
University of Rochester-AD-CARE Program
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Atrium Health Department of Psychiatry
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Duke Neurology Research
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
AMC Research, LLC
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Facility Name
Insight Clinical Trials, LLC
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Neurology Diagnostics
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Neurobehavioral Clinical Research
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Facility Name
Summit Research Network Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Center for Cognitive Health
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Keystone Clinical Studies
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Facility Name
Rhode Island Mood & Memory Research Institute
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Neurology Clinical, P.C.
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Senior Adults Specialty Research
City
Austin
State/Province
Texas
ZIP/Postal Code
98757
Country
United States
Facility Name
Grayline Research Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Evergreen Health Research Program
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Northwest Neurological
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
St Vincent's Centre for Applied Medical Research, Translational Research Centre
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Hammondcare Greenwich Hospital
City
Greenwich
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
KaRa MINDS
City
Macquarie Park
State/Province
New South Wales
ZIP/Postal Code
2113
Country
Australia
Facility Name
HammondCare
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Australian Alzheimer's Research Organization
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Open Label Study of ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease
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