Clinical trial: A Trial to Evaluate the Efficacy and Safety of PQ912 in Patients With Early AD (NCT03919162)

Eligibility criteria:
Key Inclusion Criteria:

          -  Age 50-89 (inclusive) at screening

          -  Diagnosed as having Mild Cognitive Impairment (MCI) due to Alzheimer's disease (AD) or
             Mild probable AD according to workgroups of the Diagnostic Guidelines of the National
             Institute on Aging and Alzheimer's Association (NIA-AA)

          -  Mini-Mental State Examination (MMSE) score 20-30 inclusive at screening

          -  Montreal Cognitive Assessment score (MoCA) < 26 at screening

          -  Clinical Dementia Rating global score 0.5 or 1 with memory score of > 0.5 at screening

          -  Positive CSF AD biomarker signature

          -  A brain MRI scan within 6 months of screening consistent with a diagnosis of
             Alzheimer's disease

          -  Participants must have a study partner who has frequent interaction with them
             (approximately >3-4 times per week), will be present for all clinic visits, and can
             assist in compliance with study procedures.

        Key Exclusion Criteria:

          -  • Significant neurodegenerative diseases and causes of dementia, other than AD,
             including Parkinson's disease and Huntington's disease, vascular dementia, CJD
             (Creutzfeldt-Jakob disease), LBD (Lewy Body dementia), PSP (Progressive Supranuclear
             Palsy), AIDS (Acquired Immunodeficiency Syndrome), or NPH (normal pressure
             hydrocephalus)

          -  Meeting Diagnostic Criteria for Possible AD according to workgroups of the Diagnostic
             Guidelines of the NIA-AA

          -  Hepatic impairment defined as Child-Pugh class A or more severe liver impairment

          -  History of moderate or severe skin reactions to medications or current moderate or
             severe disease of the skin and subcutaneous tissues

          -  History of a major depressive episode within the past 6 months of screening

          -  History of diagnosis of schizophrenia

          -  History of uncontrolled bipolar disorder within past five years of screening

          -  History of seizures within past two years of screening

          -  Contraindication to lumbar puncture and MRI

          -  Participation in another clinical trial for an investigational agent and having taken
             at least one dose of study drug, unless confirmed as having been on placebo, within 90
             days prior to the baseline visit. The end of a previous investigational trial is
             defined as the date of the last dose of an investigational agent.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 89 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