Trial Review

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Trial details imported from ClinicalTrials.gov

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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04491006