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Trial record 1 of 1 for:    NCT04488419
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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. Identifier: NCT04488419
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : November 4, 2021
Information provided by (Responsible Party):
Athira Pharma

Brief Summary:
This study is designed to evaluate safety and efficacy of 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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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 : September 2022
Estimated Study Completion Date : October 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. 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 global impression of change (Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change [ADCS-CGIC]

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)

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

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
  • 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
  • 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 identifier (NCT number): NCT04488419

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Contact: Xue Hua, Ph.D. 1-800-668-4717

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Sponsors and Collaborators
Athira Pharma
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Responsible Party: Athira Pharma Identifier: NCT04488419    
Other Study ID Numbers: ATH-1017-AD-0201
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: November 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
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders