A Study of ATH-1017 in Mild to Moderate Alzheimer's Disease

NCT ID: NCT04491006

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-23
• Study Completion Date: 2022-05-20

Brief Summary

This study is designed to evaluate treatment effects of ATH-1017 (fosgonimeton) in mild to moderate Alzheimer's subjects with a randomized treatment duration of 26-weeks.

Detailed Description

This study is designed to assess the correlation of the functional translational biomarker P300 latency and change in ADAS-Cog11 induced by ATH-1017 therapy, over 26-week randomized, double-blind treatment.

Conditions

Alzheimer Disease; Dementia of Alzheimer Type

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Low Dose

Daily subcutaneous (SC) injection of Low Dose ATH-1017

Group Type: EXPERIMENTAL

ATH-1017

Intervention Type: DRUG

Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe

High Dose

Daily subcutaneous (SC) injection of High Dose ATH-1017

Group Type: EXPERIMENTAL

ATH-1017

Intervention Type: DRUG

Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe

Placebo

Daily subcutaneous (SC) injection of Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Daily subcutaneous (SC) injection of Placebo in a pre-filled syringe

Interventions

ATH-1017

Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe

Intervention Type: DRUG

Placebo

Daily subcutaneous (SC) injection of Placebo in a pre-filled syringe

Intervention Type: DRUG

Eligibility Criteria

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)
• Reliable and capable support person/caregiver
• Treatment-free or receiving stable acetylcholinesterase inhibitor (AChEI) treatment, defined as:

• Treatment-naïve, OR
• Subjects are on a stable, approved dose of an AChEI (except for donepezil at 23 mg PO) for at least 3 months before Screening OR
• Subjects who received an AChEI in the past and discontinued 4 weeks prior to Screening

Exclusion Criteria

• History of significant neurologic disease, other than AD, that may affect cognition, or concurrent with the onset of dementia
• History of unexplained loss of consciousness, and epileptic fits (unless febrile)
• 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
• Hearing test result considered unacceptable for auditory ERP P300 assessment
• 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 (in the judgment of the investigator) cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (note: pacemaker is acceptable)
• Subject has either hypertension (supine diastolic blood pressure > 95 mmHg), or symptomatic hypotension in the judgment of the investigator
• Clinically significant ECG abnormality at Screening
• Renal insufficiency (serum creatinine > 2.0 mg/dL)
• 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
• Donepezil at 23 mg PO
• 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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Athira Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Syrentis Clinical Research

Santa Ana, California, United States

Premiere Research Institute

West Palm Beach, Florida, United States

iResearch Atlanta

Decatur, Georgia, United States

Neurological Associates of Albany

Albany, New York, United States

Center for Cognitive Health

Portland, Oregon, United States

Evergreen Health Research Program

Kirkland, Washington, United States

University of Washington

Seattle, Washington, United States

Central Coast Neurosciences Research

Central Coast, New South Wales, Australia

St Vincent's Centre for Applied Medical Research, Translational Research Centre

Darlinghurst, New South Wales, Australia

Hammondcare Greenwich Hospital

Greenwich, 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

Countries

United States; Australia

References

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.

Reference Type: BACKGROUND

PMID: 21514250 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1255-9714

Identifier Type: OTHER

Identifier Source: secondary_id

18PTC-R-589358

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1R01AG068268-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ATH-1017-AD-0202

Identifier Type: -

Identifier Source: org_study_id