History of Changes for Study: NCT04886063

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

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Study Record Versions

Version	Submitted Date	Changes
1	May 10, 2021	None (earliest Version on record)
2	May 17, 2021	Conditions and Study Status
3	June 30, 2021	Recruitment Status, Study Status and Contacts/Locations
4	August 24, 2021	Study Status
5	February 28, 2022	Study Status, Contacts/Locations and Study Description
6	February 15, 2023	Contacts/Locations, Study Status, Study Design, Outcome Measures and Study Description
7	August 17, 2023	Study Status, Outcome Measures, Contacts/Locations, Arms and Interventions and Study Description

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Merged
Side-by-Side

Study Identification


Unique Protocol ID:	ATH-1017-AD-0203
Brief Title:	Open Label Study of ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease
Official Title:	Open-Label Extension of Studies ATH-1017-AD-0201 and ATH-1017-AD-0202 in Subjects With Mild to Moderate Alzheimer's Disease
Secondary IDs:

Study Status


Record Verification:	May 2021
Overall Status:	Not yet recruiting
Study Start:	May 2021
Primary Completion:	April 2023 [Anticipated]
Study Completion:	May 2023 [Anticipated]

First Submitted:	May 10, 2021
First Submitted that Met QC Criteria:	May 10, 2021
First Posted:	May 13, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	May 10, 2021
Last Update Posted:	May 13, 2021 [Actual]

Sponsor/Collaborators


Sponsor:	Athira Pharma
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description

Brief Summary:

The objective of this study is to determine the safety and tolerability of 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.

Detailed Description:

This is a multicenter, seamless, open-label extension (OLEX) study of ATH-1017 treatment in subjects with a clinical diagnosis of mild to moderate Alzheimer's disease who completed 26 weeks treatment in the randomized, placebo-controlled, double-blind studies, ATH-1017-AD-0201 and ATH-1017-AD-0202. This OLEX study will provide additional, longer-term safety and tolerability information on ATH-1017 administration up to one year in total in subjects with mild to moderate Alzheimer's disease.

Conditions


Conditions:	Alzheimer Disease
Keywords:	Alzheimer's, dementia, ATH-1017, open label

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2
Interventional Study Model:	Single Group Assignment
	Open label extension
Number of Arms:	1
Masking:	None (Open Label)
Allocation:	N/A
Enrollment:	300 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Treatment Daily subcutaneous (SC) injection of ATH-1017	Drug: ATH-1017 Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe

Outcome Measures


Primary Outcome Measures:
1.	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 26 Weeks ] Safety and tolerability of ATH-1017 as measured by clinical laboratory measures, vital signs, and physical and neurological exams.

Eligibility


Minimum Age:	55 Years
Maximum Age:	85 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: 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. Exclusion Criteria: 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

Contacts/Locations


Central Contact Person:	Hua Xue, Ph.D. Telephone: 206-221-8112 Email: clinicaltrials@athira.com
Locations:

IPDSharing


Plan to Share IPD:

References


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