ATHIRA Pharmaceuticals trial for mild/moderate Alzheimer’s Disease

A Translational Study of ATH-1017 in Mild to Moderate Alzheimer’s Disease (ACT-AD), a randomized, double-blind, placebo-controlled, parallel-group 26-week trial evaluating ATH-1017 for the treatment of mild-to-moderate Alzheimer’s disease. ATH-1017 is designed to enhance synaptic activity. Sub-cutaneous injection.   MMSE/MoCA: MMSE 14-24 Diagnosis: dementia, due probably to AD Additional relevant Inclusion/Exclusion Criteria:

• Clinically significant cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (note: pacemaker is acceptable)
• Treatment-free or receiving stable acetylcholinesterase inhibitor (AChEI) treatment, defined as:
  • Treatment-naïve, OR
  • Subjects who receive continuous dosing for at least 6 months, and are on a stable, approved dose of an AChEl for at least 3 moths before screening, OR
• 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 (Namenda®) and combination product of donepezil and memantine product (Namzaric®) within 6 weeks prior to Screening