ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease

Phase 2

Completed

• Conditions: Alzheimer Disease; Dementia of Alzheimer Type
• Interventions: Drug: ATH-1017; Drug: Placebo

• Registration Number: NCT04488419
• Lead Sponsor: Athira Pharma

Brief Summary

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.

Detailed Description

The study is designed to evaluate safety and efficacy of ATH-1017 in mild to moderate AD subjects, with randomized, parallel-arm treatment duration of 26 weeks, and based on clinical diagnostic criteria of Alzheimer's disease. Clinical efficacy is demonstrated by improvement in cognition and global/functional assessments comparing treatment to placebo.

Study Timeline

• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-23
• Study First Posted: 2020-07-28
• Study Start: 2020-09-28
• Primary Completion: 2024-07-15
• Study Completion: 2024-07-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 554

Inclusion Criteria

• 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

Key

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Exclusion Criteria

• History of significant neurologic disease, other than AD, that may affect cognition, or concurrent with the onset of dementia
• Subject has atypical variant presentation of AD, if known from medical history, particularly non-amnestic AD
• History of brain MRI scan indicative of any other significant abnormality
• Diagnosis of severe major depressive disorder even without psychotic features.
• Significant suicide risk
• History within 2 years of Screening, or current diagnosis of psychosis
• 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
• Clinically significant ECG abnormality at Screening
• Chronic kidney disease with estimated glomerular filtration rate (eGFR) <45 mL/min
• 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
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dosage	ATH-1017	Daily subcutaneous (SC) injection of 40mg ATH-1017
Placebo	Placebo	Daily subcutaneous (SC) injection of Placebo

Primary Outcome Measures

Name	Time	Method
To evaluate the clinical efficacy of ATH1017 in subjects not on background acetylcholinesterase inhibitors (AChEIs)	Week 26	The Global Statistical Test (GST) score that combines the change from baseline scores from cognition (Alzheimer's Disease Assessment Scale-Cognitive Subscale \[ADAS-Cog11\]) and function (Alzheimer's Disease Cooperative Study-Activities of Daily Living, 23-item version \[ADCS-ADL23\] score)

Secondary Outcome Measures

Name	Time	Method
Cognition	Week 26	Alzheimer's Disease Assessment Scale-Cognitive Subscale \[ADAS-Cog11\] (Range of 0 to 70, where 0 is least impairment and 70 is most severe impairment)
Activities of Daily Living	Week 26	Alzheimer's Disease Cooperative Study - Activities of Daily Living, 23-item version \[ADCS-ADL23\] (Range of 0 to 78, where a higher score indicates greater function)
To determine the effect of ATH1017 on plasma neurofilament light chain (NfL) concentration	Week 26	NfL concentration change from Baseline at Week 26

Trial Locations

Locations (86)

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

Wr - Pri, Llc; 🇺🇸 Encino, California, United States

Neurology Center of North Orange County; 🇺🇸 Fullerton, California, United States

Sun Valley Research Center, Inc.; 🇺🇸 Imperial, California, United States

Irvine Clinical Research; 🇺🇸 Irvine, California, United States

Sunwise Clinical Research; 🇺🇸 Lafayette, California, United States

Healthy Brain Research Inc; 🇺🇸 Long Beach, California, United States

PRI Research; 🇺🇸 Newport Beach, California, United States

Viking Clinical; 🇺🇸 Temecula, California, United States

Denver Neurological Research, LLC; 🇺🇸 Denver, Colorado, United States

Mile High Research Center; 🇺🇸 Denver, Colorado, United States

CenExel RMCR; 🇺🇸 Englewood, 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

Merritt Island Medical Research; 🇺🇸 Merritt Island, Florida, United States

Global Medical Institutes, LLC dba South Miami Medical Institute; 🇺🇸 Miami, Florida, 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

Wr-Msra, Llc; 🇺🇸 Lake City, Florida, United States

ClinCloud; 🇺🇸 Maitland, Florida, United States

Optimus U Corp; 🇺🇸 Miami, Florida, United States

Quantix Research; 🇺🇸 Miami, Florida, United States

Innova Pharma; 🇺🇸 Miami, Florida, United States

K2 Medical Research Maitland; 🇺🇸 Orlando, Florida, United States

Progressive Medical Research; 🇺🇸 Port Orange, Florida, United States

Mart Medical Group Research; 🇺🇸 South Miami, Florida, United States

Premiere Research Institute; 🇺🇸 West Palm Beach, Florida, United States

K2 Medical Research-The Villages; 🇺🇸 Lady Lake, Florida, United States

CenExel iResearch, LLC; 🇺🇸 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

Indiana University School of Medicine, Department of Neurology; 🇺🇸 Indianapolis, Indiana, United States

Ochsner Clinical Foundation; 🇺🇸 New Orleans, Louisiana, United States

Northern Light Acadia Hospital; 🇺🇸 Bangor, Maine, United States

PharmaSite Research; 🇺🇸 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

Adams Clinical; 🇺🇸 Watertown, Massachusetts, United States

Clinical Research Professionals; 🇺🇸 Chesterfield, Missouri, United States

Cleveland Clinic Lou Ruvo Center for Brain Health; 🇺🇸 Las Vegas, Nevada, United States

M3 Wake Research; 🇺🇸 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, LLC; 🇺🇸 Brooklyn, New York, United States

Berman Clinical; 🇺🇸 New York, New York, United States

Manhattan Behavioral Medicine, LLC; 🇺🇸 New York, New York, United States

University of Rochester-AD-CARE Program; 🇺🇸 Rochester, New York, United States

ERG Clinical Research - New York, PLLC; 🇺🇸 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

Wake Research of Raleigh; 🇺🇸 Raleigh, 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

WR-ClinSearch, LLC; 🇺🇸 Chattanooga, Tennessee, United States

Neurology Clinical, P.C.; 🇺🇸 Cordova, Tennessee, United States

Clinical Neuroscience Solutions, Inc.; 🇺🇸 Memphis, Tennessee, United States

Austin Clinical Trials Partners; 🇺🇸 Austin, Texas, United States

Senior Adults Specialty Research; 🇺🇸 Austin, Texas, United States

Kerwin Memory Center; 🇺🇸 Dallas, Texas, United States

EI FARO Health and Therapeutics; 🇺🇸 Rio Grande City, Texas, United States

Grayline Research Center; 🇺🇸 Wichita Falls, Texas, United States

Next Stage Clinical Research; 🇺🇸 Woodway, Texas, United States

Pantheon Clinical; 🇺🇸 Bountiful, Utah, United States

University of Utah, Department of Neurology-Alzheimer's Disease Research; 🇺🇸 Salt Lake City, Utah, United States

Northwest Clinical Research Center; 🇺🇸 Bellevue, Washington, United States

Eastside Therapeutic Resource, Inc. dba Core Clinical Research; 🇺🇸 Everett, Washington, United States

Swedish Neuroscience Research; 🇺🇸 Seattle, Washington, United States

Northwest Neurological; 🇺🇸 Spokane, Washington, United States