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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04491006




Registration number
NCT04491006
Ethics application status
Date submitted
23/07/2020
Date registered
29/07/2020
Date last updated
12/06/2023

Titles & IDs
Public title
A Study of ATH-1017 in Mild to Moderate Alzheimer's Disease
Scientific title
A Randomized, Placebo-Controlled, Translational Study of ATH-1017 in Subjects With Mild to Moderate Alzheimer's Disease
Secondary ID [1] 0 0
U1111-1255-9714
Secondary ID [2] 0 0
ATH-1017-AD-0202
Universal Trial Number (UTN)
Trial acronym
ACT-AD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Dementia of Alzheimer Type 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
Treatment: Drugs - Placebo

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

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

Placebo Comparator: Placebo - Daily subcutaneous (SC) injection of Placebo


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

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

Outcomes
Primary outcome [1] 0 0
Event-related Potential (ERP) P300 Latency at Baseline
Timepoint [1] 0 0
At Baseline (Day 1)
Secondary outcome [1] 0 0
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at Baseline
Timepoint [1] 0 0
At Baseline (Day 1)

Eligibility
Key inclusion criteria
Key

- 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

Key
Minimum age
55 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

- Memantine in any form, combination or dosage within 4 weeks prior to Screening

- Donepezil at 23 mg PO

- The subject has received active amyloid or tau immunization (i.e., vaccination for
Alzheimer's disease) at any time, or passive immunization (i.e., monoclonal antibodies
for Alzheimer's disease) within 6 months of Screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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
23/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/05/2022
Sample size
Target
Accrual to date
Final
77
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Central Coast Neurosciences Research - Central Coast
Recruitment hospital [2] 0 0
St Vincent's Centre for Applied Medical Research, Translational Research Centre - Darlinghurst
Recruitment hospital [3] 0 0
Hammondcare Greenwich Hospital - Greenwich
Recruitment hospital [4] 0 0
KaRa MINDS - Macquarie Park
Recruitment hospital [5] 0 0
HammondCare - Malvern
Recruitment hospital [6] 0 0
Australian Alzheimer's Research Organization - Nedlands
Recruitment postcode(s) [1] 0 0
2261 - Central Coast
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2065 - Greenwich
Recruitment postcode(s) [4] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [5] 0 0
3144 - Malvern
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Oregon
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Athira Pharma
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute on Aging (NIA)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04491006
Trial related presentations / publications
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.
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/NCT04491006