Clinical trial: A Translational Study of ATH-1017 in Mild to Moderate Alzheimer's Disease (NCT04491006)

Eligibility criteria:
Key Inclusion Criteria:

          -  Age 55 to 85 years

          -  Mild-to-moderate AD dementia subjects, MMSE 14-24, CDR 1 or 2 at the Screening visit

          -  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 who received continuous dosing for at least 6 months, and are on a
                  stable, approved dose of an AChEI for at least 3 months before Screening OR

               -  Subjects who received an AChEI in the past and discontinued, e.g., due to
                  tolerability issues

               -  For subjects who received high dose donepezil at 23 mg PO, or galantamine at 24
                  mg PO or patch, a 3-month drug-free period is required between the last dose
                  received and 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 or Baseline

          -  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

          -  The subject has received active amyloid or tau immunization at any time, or passive
             immunization within 12 months of Screening
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 70-year-old man comes to the office accompanied by his wife.  The patient has experienced progressive memory loss over the last years.  He needs help with some of his routine activities, such as paying bills.  The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!"  Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus.  Family history includes Alzheimer disease in his father.  MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.

Patient description (patient's own words): I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test.

Does the patient match the trial criteria? Entailment