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The trial is taking place at:
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Adams Clinical | Watertown, MA

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ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease (LIFT-AD)

Athira Pharma logo

Athira Pharma

Status and phase

Active, not recruiting
Phase 3
Phase 2

Conditions

Alzheimer Disease
Dementia of Alzheimer Type

Treatments

Drug: Placebo
Drug: ATH-1017

Study type

Interventional

Funder types

Industry

Identifiers

NCT04488419
ATH-1017-AD-0201

Details and patient eligibility

About

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.

Full description

The study is designed to evaluate safety and efficacy of ATH-1017 in mild to moderate AD subjects, with randomized, 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.

Enrollment

554 patients

Sex

All

Ages

55 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

554 participants in 2 patient groups, including a placebo group

Dosage
Experimental group
Description:
Daily subcutaneous (SC) injection of 40mg ATH-1017
Treatment:
Drug: ATH-1017
Placebo
Placebo Comparator group
Description:
Daily subcutaneous (SC) injection of Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

90

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Central trial contact

Hans Moebius, MD, PhD

Data sourced from clinicaltrials.gov

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