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ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease (LIFT-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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04488419
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : March 22, 2023
Sponsor:
Information provided by (Responsible Party):
Athira Pharma

Study Description
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Brief Summary:
This study is designed to evaluate safety and efficacy of fosgonimeton (ATH-1017) in the treatment of mild to moderate Alzheimer's disease 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 Phase 3

Detailed Description:
The study is designed to evaluate safety and efficacy of ATH-1017 in mild to moderate AD subjects, with double-blind, parallel-arm treatment duration of 26 weeks, and based on clinical diagnostic criteria of Alzheimer's disease. Clinical efficacy is demonstrated by improvement in cognition and global/functional assessments comparing treatment to placebo.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 475 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, Double-Blind Study of ATH-1017 Treatment in Subjects With Mild to Moderate Alzheimer's Disease
Actual Study Start Date : September 28, 2020
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Overall treatment effect of ATH-1017 as reflected by the Global Statistical Test [ Time Frame: Week 26 ]
    The Global Statistical Test (GST) combines the scores from cognition (Alzheimer's Disease Assessment Scale-Cognitive Subscale [ADAS-Cog11]) and function (Alzheimer's Disease Cooperative Study-Activities of Daily Living, 23-item version [ADCS-ADL23] score)


Secondary Outcome Measures :
  1. Cognition [ Time Frame: Week 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)

  2. Clinical Global Impression of Change [ Time Frame: Week 26 ]
    Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change [ADCS-CGIC] (Range of 1 to 7, where 1 is marked improvement and 7 is marked worsening)

  3. Activities of Daily Living [ Time Frame: Week 26 ]
    Alzheimer's Disease Cooperative Study - Activities of Daily Living, 23-item version [ADCS-ADL23] (Range of 0 to 78, where a higher score indicates greater function)


Eligibility Criteria
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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)
  • Body mass index (BMI) of ≥ 18 and ≤ 35 kg/m2 at Screening
  • Reliable and capable support person/caregiver

  • Treatment-free (subjects not receiving acetylcholinesterase inhibitor [AChEI] treatment), defined as:

    • Treatment-naïve, OR
    • Subjects who received an AChEI in the past and discontinued at least 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
  • 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
  • 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 cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (note: pacemaker is acceptable)
  • Subject has either hypertension or symptomatic hypotension
  • Clinically significant ECG abnormality at Screening
  • Chronic kidney disease with estimated glomerular filtration rate (eGFR) <45 mL/min
  • 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
  • Acetylcholinesterase inhibitors in any dosage form
  • 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
Contacts and Locations
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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): NCT04488419


Contacts
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Contact: Hans Moebius, MD, PhD 425-620-8501 clinicaltrials@athira.com

Locations
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Sponsors and Collaborators
Athira Pharma
More Information
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Publications:

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Responsible Party: Athira Pharma
ClinicalTrials.gov Identifier: NCT04488419    
Other Study ID Numbers: ATH-1017-AD-0201
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: March 22, 2023
Last Verified: March 2023

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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
LIFT AD
Fosgonimeton
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