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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04886063




Registration number
NCT04886063
Ethics application status
Date submitted
10/05/2021
Date registered
13/05/2021
Date last updated
15/11/2024

Titles & IDs
Public title
Open Label Study of ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease
Scientific 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 ID [1] 0 0
ATH-1017-AD-0203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ATH-1017

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


Treatment: Drugs: ATH-1017
Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timepoint [1] 0 0
210 Weeks

Eligibility
Key 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.
Minimum age
55 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/10/2024
Sample size
Target
Accrual to date
Final
423
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Centre for Applied Medical Research, Translational Research Centre - Darlinghurst
Recruitment hospital [2] 0 0
Hammondcare Greenwich Hospital - Greenwich
Recruitment hospital [3] 0 0
KaRa MINDS - Macquarie Park
Recruitment hospital [4] 0 0
HammondCare - Malvern
Recruitment hospital [5] 0 0
Australian Alzheimer's Research Organization - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2065 - Greenwich
Recruitment postcode(s) [3] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [4] 0 0
3144 - Malvern
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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Arizona
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United States of America
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California
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Colorado
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Florida
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Georgia
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United States of America
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Hawaii
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United States of America
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Illinois
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Indiana
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Maine
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Maryland
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Massachusetts
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Missouri
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Nevada
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Rhode Island
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Tennessee
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Texas
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United States of America
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Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Athira Pharma
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04886063
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04886063