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

NCT04491006 | Completed Phase 2 Results DMC FDA Drug

• 4 other identifiers: ATH-1017-AD-0202U1111-1255-971418PTC-R-5893581R01AG068268-01
• Study Type: interventional
• Target: 77
• Locations: 2 countries
• Sites: 13

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.

Conditions

Alzheimer Disease; Dementia of Alzheimer Type

Keywords

Alzheimer's Disease; Cognition; Dementia; ATH-1017; Memory Loss

Outcome Measures

Primary Outcomes (1)

• Event-related Potential (ERP) P300 Latency at Baseline

  ERP P300 was a method of recording brain activity elicited by external stimuli, for example (e.g.), an oddball auditory stimulus, particularly of working memory access. The participant had to perform a task related to auditory stimuli in order to assess the P300 component (latency). The stimulus consisted of an oddball paradigm with 2 sound stimuli. Stimuli were presented through headphones and auditory stimulation for P300 was assessed in a recording lasting up to 10 minutes. It was calculated as the average across the pre-dose values at Baseline visit. Baseline was defined as Day 1.

  At Baseline (Day 1)

Secondary Outcomes (1)

• Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at Baseline

  At Baseline (Day 1)

Study Arms (3)

Low Dose

EXPERIMENTAL

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

Drug: ATH-1017

High Dose

EXPERIMENTAL

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

Drug: ATH-1017

Placebo

PLACEBO COMPARATOR

Daily subcutaneous (SC) injection of Placebo

Drug: Placebo

Interventions

ATH-1017 DRUG

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

High Dose; Low Dose

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Athira Pharma: lead
• National Institute on Aging (NIA): collaborator

Study Sites (13)

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

Premiere Research Institute

West Palm Beach, Florida, 33407, United States

Location

iResearch Atlanta

Decatur, Georgia, 30030, United States

Location

Neurological Associates of Albany

Albany, New York, 12208, United States

Location

Center for Cognitive Health

Portland, Oregon, 97225, United States

Location

Evergreen Health Research Program

Kirkland, Washington, 98034, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Central Coast Neurosciences Research

Central Coast, New South Wales, 2261, Australia

Location

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

Darlinghurst, New South Wales, 2010, Australia

Location

Hammondcare Greenwich Hospital

Greenwich, New South Wales, 2065, Australia

Location

KaRa MINDS

Macquarie Park, New South Wales, 2113, Australia

Location

HammondCare

Malvern, Victoria, 3144, Australia

Location

Australian Alzheimer's Research Organization

Nedlands, Western Australia, 6009, Australia

Location

Related 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.

  PMID: 21514250 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Memory Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Hans Moebius, CMO
• Organization: Athira Pharma

clinicaltrials@athira.com

1-866-725-0930

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, parallel-group study

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 29, 2020
• Study Start: November 23, 2020
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: June 12, 2023
• Results First Posted: June 12, 2023

Record last verified: 2023-05

Locations

AU (6); US (7)