A Study of ATH-1017 in Mild to Moderate Alzheimer's Disease
Condition: Alzheimer Disease; Dementia of Alzheimer Type
MeSH terms: Alzheimer Disease; Dementia
Intervention: ATH-1017; Placebo
Intervention description: Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe; Daily subcutaneous (SC) injection of Placebo in a pre-filled syringe
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
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)
Enrollment: 77.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Alzheimer's Disease; Cognition; Dementia; ATH-1017; Memory Loss

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

Eligibility 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