ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease (LIFT-AD)

A Randomized, Placebo-Controlled, Double-Blind Study of ATH-1017 Treatment in Subjects With Mild to Moderate Alzheimer's Disease

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alzheimer Disease; Dementia of Alzheimer Type
• Intervention / Treatment: Drug: ATH-1017; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 554
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Hans Moebius, MD, PhD; Phone Number: 425-620-8501; Email: clinicaltrials@athira.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Xenoscience
    • Sun City, Arizona, United States, 85351
      • Banner Sun Health Research Institute
  • California
    • Costa Mesa, California, United States, 92626
      • ATP Clinical Research, Inc
    • Encino, California, United States, 91316
      • Wr - Pri, Llc
    • Fullerton, California, United States, 92835
      • Neurology Center of North Orange County
    • Imperial, California, United States, 92251
      • Sun Valley Research Center, Inc.
    • Irvine, California, United States, 92614
      • Irvine Clinical Research
    • Lafayette, California, United States, 94549
      • Sunwise Clinical Research
    • Long Beach, California, United States, 90804
      • Healthy Brain Research Inc
    • Los Alamitos, California, United States, 90720
      • PRI Research
    • Newport Beach, California, United States, 92660
      • PRI Research
    • Temecula, California, United States, 92591
      • Viking Clinical
  • Colorado
    • Denver, Colorado, United States, 80218
      • Mile High Research Center
    • Denver, Colorado, United States, 80210
      • Denver Neurological Research, LLC
    • Englewood, Colorado, United States, 80113
      • CenExel RMCR
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research Institute
    • Boynton Beach, Florida, United States, 33437
      • Boynton Beach Medical Research Institute
    • Clermont, Florida, United States, 34711
      • K2 Medical Research Winter Garden
    • DeLand, Florida, United States, 32720
      • Accel Clinical Research
    • Delray Beach, Florida, United States, 33445
      • Brain Matters Research
    • Fort Myers, Florida, United States, 33912
      • Neuropsychiatric Research Center of SW Florida
    • Hialeah, Florida, United States, 33012
      • Reliable Clinical Research LLC
    • Lady Lake, Florida, United States, 32159
      • K2 Medical Research-The Villages
    • Lake City, Florida, United States, 32055
      • Wr-Msra, Llc
    • Maitland, Florida, United States, 32751
      • ClinCloud
    • Merritt Island, Florida, United States, 32952
      • Merritt Island Medical Research
    • Miami, Florida, United States, 33125
      • Optimus U Corp
    • Miami, Florida, United States, 33125
      • Global Medical Institutes, LLC dba South Miami Medical Institute
    • Miami, Florida, United States, 33155
      • Quantix Research
    • Miami, Florida, United States, 33175
      • Innova Pharma
    • Orlando, Florida, United States, 32751
      • K2 Medical Research Maitland
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research
    • Port Orange, Florida, United States, 32127
      • Accel Clinical Research
    • Saint Petersburg, Florida, United States, 33709
      • Accel Clinical Research
    • South Miami, Florida, United States, 33143
      • Mart Medical Group Research
    • West Palm Beach, Florida, United States, 33407
      • Premiere Research Institute
  • Georgia
    • Decatur, Georgia, United States, 30030
      • CenExel iResearch, LLC
    • Decatur, Georgia, United States, 30030
      • Accel Clinical Research
    • Savannah, Georgia, United States, 31405
      • CenExel
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Hawaii Pacific Neuroscience, Memory Disorders Center & Alzheimer's Research
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush Alzheimer's Disease Center, Rush University Medical Center
    • Springfield, Illinois, United States, 62794
      • SIU Medicine Neuroscience Institute (NSI)
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine, Department of Neurology
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinical Foundation
  • Maine
    • Bangor, Maine, United States, 04401
      • Northern Light Acadia Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • PharmaSite Research
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02129
      • Massachusetts General Hospital
    • Lowell, Massachusetts, United States, 01852
      • ActivMed Practices & Research, Inc.
    • Newton, Massachusetts, United States, 02459
      • Boston Center for Memory
    • Watertown, Massachusetts, United States, 02472
      • Adams Clinical
  • Missouri
    • Chesterfield, Missouri, United States, 63005
      • Clinical Research Professionals
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Cleveland Clinic Lou Ruvo Center for Brain Health
    • Las Vegas, Nevada, United States, 89106
      • M3 Wake Research
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack Meridian Hackensack University Medical Center
    • Princeton, New Jersey, United States, 08540
      • Global Medical Institutes LLC; Princeton Medical Institute
    • Toms River, New Jersey, United States, 08755
      • Advanced Memory Research Institute of NJ
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Albuquerque Neuroscience Inc.
  • New York
    • Albany, New York, United States, 12208
      • Neurological Associates of Albany
    • Brooklyn, New York, United States, 11229
      • Integrative Clinical Trials, LLC
    • New York, New York, United States, 10036
      • Manhattan Behavioral Medicine, LLC
    • New York, New York, United States, 10029
      • Berman Clinical
    • Rochester, New York, United States, 14620
      • University of Rochester-AD-CARE Program
    • Staten Island, New York, United States, 10312
      • ERG Clinical Research - New York, PLLC
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • Atrium Health Department of Psychiatry
    • Durham, North Carolina, United States, 27705
      • Duke Neurology Research
    • Matthews, North Carolina, United States, 28105
      • AMC Research, LLC
    • Raleigh, North Carolina, United States, 27612
      • Wake Research of Raleigh
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Insight Clinical Trials, LLC
    • Dayton, Ohio, United States, 45459
      • Neurology Diagnostics
    • North Canton, Ohio, United States, 44720
      • Neurobehavioral Clinical Research
  • Oregon
    • Portland, Oregon, United States, 97225
      • Center for Cognitive Health
    • Portland, Oregon, United States, 97210
      • Summit Research Network Inc.
  • Pennsylvania
    • Norristown, Pennsylvania, United States, 19462
      • Keystone Clinical Studies
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Rhode Island Mood & Memory Research Institute
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • WR-Clinsearch, LLC
    • Cordova, Tennessee, United States, 38018
      • Neurology Clinical, P.C.
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc.
  • Texas
    • Austin, Texas, United States, 98757
      • Senior Adults Specialty Research
    • Austin, Texas, United States, 78737
      • Austin Clinical Trials Partners
    • Dallas, Texas, United States, 75231
      • Kerwin Memory Center
    • Rio Grande City, Texas, United States, 78582
      • EI FARO Health and Therapeutics
    • Wichita Falls, Texas, United States, 76309
      • Grayline Research Center
    • Woodway, Texas, United States, 76712
      • Next Stage Clinical Research
  • Utah
    • Bountiful, Utah, United States, 84010
      • Pantheon Clinical
    • Salt Lake City, Utah, United States, 84108
      • University of Utah, Department of Neurology-Alzheimer's Disease Research
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Everett, Washington, United States, 98201
      • Eastside Therapeutic Resource, Inc. dba Core Clinical Research
    • Seattle, Washington, United States, 98122
      • Swedish Neuroscience Research
    • Spokane, Washington, United States, 99202
      • Northwest Neurological

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Daily subcutaneous (SC) injection of Placebo	Drug: Placebo; Daily subcutaneous (SC) injection of Placebo in a pre-filled syringe
Experimental: Dosage; Daily subcutaneous (SC) injection of 40mg ATH-1017	Drug: ATH-1017; Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the clinical efficacy of ATH1017 in subjects not on background acetylcholinesterase inhibitors (AChEIs)	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)	Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognition	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)	Week 26
Activities of Daily Living	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)	Week 26
To determine the effect of ATH1017 on plasma neurofilament light chain (NfL) concentration	NfL concentration change from Baseline at Week 26	Week 26

Collaborators and Investigators

• Sponsor: Athira Pharma

Publications and helpful links

General Publications

• McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 23, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Alzheimer's Disease; Dementia; Cognition; ATH-1017; LIFT AD; Fosgonimeton
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: ATH-1017-AD-0201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No