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A Translational Study of ATH-1017 in Mild to Moderate Alzheimer's Disease (ACT-AD)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04491006
Recruitment Status : Active, not recruiting
First Posted : July 29, 2020
Last Update Posted : November 2, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Athira Pharma

Brief Summary:
This study is designed to evaluate treatment effects of ATH-1017 in mild to moderate Alzheimer's subjects with a randomized treatment duration of 26-weeks.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Dementia of Alzheimer Type Drug: ATH-1017 Drug: Placebo Phase 2

Detailed Description:
This study is designed to assess the correlation of the functional translational biomarker P300 latency and change in ADAS-Cog11 induced by ATH-1017 therapy, over 26-week randomized, double-blind treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled, parallel-group study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Translational Study of ATH-1017 in Subjects With Mild to Moderate Alzheimer's Disease
Actual Study Start Date : November 23, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Dose
Daily subcutaneous (SC) injection of Low Dose ATH-1017
Drug: ATH-1017
Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe

Experimental: High Dose
Daily subcutaneous (SC) injection of High Dose ATH-1017
Drug: ATH-1017
Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe

Placebo Comparator: Placebo
Daily subcutaneous (SC) injection of Placebo
Drug: Placebo
Daily subcutaneous (SC) injection of Placebo in a pre-filled syringe




Primary Outcome Measures :
  1. Event-Related Potential [ Time Frame: Week 26 ]
    Event-related potential (ERP) P300 latency


Secondary Outcome Measures :
  1. Cognition [ Time Frame: Weeks 2, 6, 12, 20, and 26 ]
    Alzheimer's Disease Assessment Scale-Cognitive Subscale [ADAS-Cog11] (Range of 0 to 70, where 0 is least impairment and 70 is most severe impairment)



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04491006


Locations
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United States, California
Syrentis Clinical Research
Santa Ana, California, United States, 92705
United States, Florida
Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Georgia
iResearch Atlanta
Decatur, Georgia, United States, 30030
United States, New York
Neurological Associates of Albany
Albany, New York, United States, 12208
United States, Oregon
Center for Cognitive Health
Portland, Oregon, United States, 97225
United States, Washington
Evergreen Health Research Program
Kirkland, Washington, United States, 98034
University of Washington
Seattle, Washington, United States, 98104
Australia, New South Wales
Central Coast Neurosciences Research
Central Coast, New South Wales, Australia, 2261
St Vincent's Centre for Applied Medical Research, Translational Research Centre
Darlinghurst, New South Wales, Australia, 2010
Hammondcare Greenwich Hospital
Greenwich, New South Wales, Australia, 2065
KaRa MINDS
Macquarie Park, New South Wales, Australia, 2113
Australia, Victoria
HammondCare
Malvern, Victoria, Australia, 3144
Australia, Western Australia
Australian Alzheimer's Research Organization
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Athira Pharma
National Institute on Aging (NIA)
Publications:
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Responsible Party: Athira Pharma
ClinicalTrials.gov Identifier: NCT04491006    
Other Study ID Numbers: ATH-1017-AD-0202
U1111-1255-9714 ( Other Identifier: WHO (UTN) )
18PTC-R-589358 ( Other Grant/Funding Number: Alzheimer's Association )
1R01AG068268-01 ( U.S. NIH Grant/Contract )
First Posted: July 29, 2020    Key Record Dates
Last Update Posted: November 2, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Athira Pharma:
Alzheimer's Disease
Cognition
Dementia
ATH-1017
Memory Loss
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders