Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04886063




Registration number
NCT04886063
Ethics application status
Date submitted
10/05/2021
Date registered
13/05/2021
Date last updated
21/08/2023

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
130 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
N/A
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/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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
1/02/2027
Actual
Sample size
Target
450
Accrual to date
Final
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Hawaii
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nevada
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Rhode Island
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
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/ct2/show/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/ct2/show/NCT04886063