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

Alzheimer Disease Clinical Trial

— LIFT-AD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04488419
• Other study ID #: ATH-1017-AD-0201
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: September 28, 2020
• Est. completion date: August 2024

Study information

• Verified date: January 2024
• Source: Athira Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 554
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia of Alzheimer Type

Intervention

Drug:
• ATH-1017
Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe
• Placebo
Daily subcutaneous (SC) injection of Placebo in a pre-filled syringe

Locations

Country	Name	City	State
United States	Neurological Associates of Albany	Albany	New York
United States	Albuquerque Neuroscience Inc.	Albuquerque	New Mexico
United States	JEM Research Institute	Atlantis	Florida
United States	Austin Clinical Trials Partners	Austin	Texas
United States	Senior Adults Specialty Research	Austin	Texas
United States	PharmaSite Research	Baltimore	Maryland
United States	Northern Light Acadia Hospital	Bangor	Maine
United States	Insight Clinical Trials, LLC	Beachwood	Ohio
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Pantheon Clinical	Bountiful	Utah
United States	Boynton Beach Medical Research Institute	Boynton Beach	Florida
United States	Integrative Clinical Trials, LLC	Brooklyn	New York
United States	Massachusetts General Hospital	Charlestown	Massachusetts
United States	Atrium Health Department of Psychiatry	Charlotte	North Carolina
United States	WR-ClinSearch, LLC	Chattanooga	Tennessee
United States	Clinical Research Professionals	Chesterfield	Missouri
United States	Rush Alzheimer's Disease Center, Rush University Medical Center	Chicago	Illinois
United States	K2 Medical Research Winter Garden	Clermont	Florida
United States	Neurology Clinical, P.C.	Cordova	Tennessee
United States	ATP Clinical Research, Inc	Costa Mesa	California
United States	Kerwin Memory Center	Dallas	Texas
United States	Neurology Diagnostics	Dayton	Ohio
United States	Accel Clinical Research	Decatur	Georgia
United States	CenExel iResearch, LLC	Decatur	Georgia
United States	Accel Clinical Research	DeLand	Florida
United States	Brain Matters Research	Delray Beach	Florida
United States	Denver Neurological Research, LLC	Denver	Colorado
United States	Mile High Research Center	Denver	Colorado
United States	Duke Neurology Research	Durham	North Carolina
United States	Rhode Island Mood & Memory Research Institute	East Providence	Rhode Island
United States	Wr - Pri, Llc	Encino	California
United States	CenExel RMCR	Englewood	Colorado
United States	Eastside Therapeutic Resource, Inc. dba Core Clinical Research	Everett	Washington
United States	Neuropsychiatric Research Center of SW Florida	Fort Myers	Florida
United States	Neurology Center of North Orange County	Fullerton	California
United States	Hackensack Meridian Hackensack University Medical Center	Hackensack	New Jersey
United States	Reliable Clinical Research LLC	Hialeah	Florida
United States	Hawaii Pacific Neuroscience, Memory Disorders Center & Alzheimer's Research	Honolulu	Hawaii
United States	Sun Valley Research Center, Inc.	Imperial	California
United States	Indiana University School of Medicine, Department of Neurology	Indianapolis	Indiana
United States	Irvine Clinical Research	Irvine	California
United States	K2 Medical Research-The Villages	Lady Lake	Florida
United States	Sunwise Clinical Research	Lafayette	California
United States	Wr-Msra, Llc	Lake City	Florida
United States	Cleveland Clinic Lou Ruvo Center for Brain Health	Las Vegas	Nevada
United States	M3 Wake Research	Las Vegas	Nevada
United States	Healthy Brain Research Inc	Long Beach	California
United States	PRI Research	Los Alamitos	California
United States	Activmed Practices & Research, Inc.	Lowell	Massachusetts
United States	ClinCloud	Maitland	Florida
United States	AMC Research, LLC	Matthews	North Carolina
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	Merritt Island Medical Research	Merritt Island	Florida
United States	Global Medical Institutes, LLC dba South Miami Medical Institute	Miami	Florida
United States	Innova Pharma	Miami	Florida
United States	Optimus U Corp	Miami	Florida
United States	Quantix Research	Miami	Florida
United States	Ochsner Clinical Foundation	New Orleans	Louisiana
United States	Berman Clinical	New York	New York
United States	Manhattan Behavioral Medicine, LLC	New York	New York
United States	PRI Research	Newport Beach	California
United States	Boston Center for Memory	Newton	Massachusetts
United States	Keystone Clinical Studies	Norristown	Pennsylvania
United States	Neurobehavioral Clinical Research	North Canton	Ohio
United States	K2 Medical Research Maitland	Orlando	Florida
United States	Xenoscience	Phoenix	Arizona
United States	Accel Clinical Research	Port Orange	Florida
United States	Progressive Medical Research	Port Orange	Florida
United States	Center for Cognitive Health	Portland	Oregon
United States	Summit Research Network Inc.	Portland	Oregon
United States	Global Medical Institutes LLC; Princeton Medical Institute	Princeton	New Jersey
United States	Wake Research of Raleigh	Raleigh	North Carolina
United States	EI FARO Health and Therapeutics	Rio Grande City	Texas
United States	University of Rochester-AD-CARE Program	Rochester	New York
United States	Accel Clinical Research	Saint Petersburg	Florida
United States	University of Utah, Department of Neurology-Alzheimer's Disease Research	Salt Lake City	Utah
United States	CenExel	Savannah	Georgia
United States	Swedish Neuroscience Research	Seattle	Washington
United States	Mart Medical Group Research	South Miami	Florida
United States	Northwest Neurological	Spokane	Washington
United States	SIU Medicine Neuroscience Institute (NSI)	Springfield	Illinois
United States	ERG Clinical Research - New York, PLLC	Staten Island	New York
United States	Banner Sun Health Research Institute	Sun City	Arizona
United States	Viking Clinical	Temecula	California
United States	Advanced Memory Research Institute of NJ	Toms River	New Jersey
United States	Adams Clinical	Watertown	Massachusetts
United States	Premiere Research Institute	West Palm Beach	Florida
United States	Grayline Research Center	Wichita Falls	Texas
United States	Next Stage Clinical Research	Woodway	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Athira Pharma

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	To determine the effect of ATH1017 on plasma neurofilament light chain (NfL) concentration	NfL concentration change from Baseline at Week 26	Week 26