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

NCT04886063 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: ATH-1017-AD-0203
• Study Type: interventional
• Target: 423
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine the safety and tolerability of fosgonimeton (ATH-1017) in subjects with mild to moderate Alzheimer's disease who completed the 26-week randomized treatment in Study ATH-1017-AD-0201 or Study ATH-1017-AD-0202.

Conditions

Alzheimer Disease

Keywords

Alzheimer's; Dementia; ATH-1017; Open Label

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Description - To determine the safety and tolerability of ATH-1017 in subjects with mild to moderate Alzheimer's disease (AD) who completed the 26-week randomized treatment in Study ATH-1017-AD-0201 or Study ATH-1017-AD-0202

  Up to 173 weeks (study termination)

Study Arms (1)

Treatment

EXPERIMENTAL

Daily subcutaneous (SC) injection of ATH-1017 - 40mg Dosage

Drug: ATH-1017

Interventions

ATH-1017 DRUG

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

Treatment

Eligibility Criteria

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

You may qualify if:

• Subject has completed the Week 26 visit of either of the two blinded parent studies (ATH-1017-AD-0201 or ATH-1017-AD-0202).
• Reliable and capable support person/caregiver who is willing to accept responsibility for supervising the daily treatment or, if required, administering study drug.
• Subject capable of giving signed informed consent, or by a legally acceptable representative.
• Subjects must be in generally good health.
• Male subjects and their partners must agree to continue to use a double-barrier method of contraception during the study, including the follow-up period, unless the partner is not of childbearing potential.

You may not qualify if:

• Subject has experienced a serious adverse event during the parent study, which could present an increased safety risk during the open label extension.
• New diagnosis of severe major depressive disorder even without psychotic features.
• Any subject with formalized delusions or hallucinations.
• Significant suicide risk.
• Newly-diagnosed malignant tumor, except for the following conditions that are stable in the judgement of the investigator:
• Adequately treated squamous and basal cell carcinoma, or squamous and basal cell carcinoma in situ
• Prostate carcinoma in situ

Sponsors & Collaborators

• Athira Pharma: lead

Study Sites (1)

University of Rochester-AD-CARE Program

Rochester, New York, 14620, United States

Location

Related Publications (1)

• Reda SM, Setti SE, Berthiaume AA, Wu W, Taylor RW, Johnston JL, Stein LR, Moebius HJ, Church KJ. Fosgonimeton attenuates amyloid-beta toxicity in preclinical models of Alzheimer's disease. Neurotherapeutics. 2024 Jul;21(4):e00350. doi: 10.1016/j.neurot.2024.e00350. Epub 2024 Apr 9.

  PMID: 38599894 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

The study was terminated early, following the completion of the parent study (ATH-1017-AD-0201; LIFT-AD)

Results Point of Contact

• Title: Dr. Javier San Martin, 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label extension

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 13, 2021
• Study Start: June 30, 2021
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2024
• Last Updated: April 1, 2025
• Results First Posted: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)