Clinical trial: Pilot Study Assessing the Effects of PXT00864 in Patients With Mild Alzheimer Disease (AD) (NCT02361424)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female patients aged ≥ 60 years.

          -  Patient with a diagnosis of probable AD

          -  Progressive decline in cognition for more than six months which story is documented in
             patient medical records

          -  A Mini-Mental State Examination (MMSE) score of 20-26

          -  With a minimum of educational background

          -  Naïve to anti-dementia treatment

          -  MRI assessment which corroborates the clinical diagnosis (hippocampal atrophy) and
             excludes other potential causes of dementia especially cerebrovascular lesions

          -  If available, Cerebral Spinal Fluid (CSF) classical biomarkers should be at levels
             which corroborate the clinical diagnosis

          -  Ambulatory patient living at home with a caregiver available and living in the same
             household or interacting with the patient daily and available if necessary to ensure
             administration of the investigational product

          -  Absence of major or severe depressive disease

          -  Patient with a willingness to participate in this study and who have signed an
             informed consent form

        Exclusion Criteria:

          -  Early onset of dementia, i.e. before 60 years old to avoid hereditary AD forms

          -  Significant neurological disease other than AD

          -  Major psychiatric disorder or syndrome (schizophrenia or bipolar disorder)

          -  Seizure disorders

          -  Other infectious, metabolic or systemic diseases affecting central nervous system

          -  Other active clinically significant illness

          -  Hospitalization or change of chronic concomitant medications one month prior to
             screening

          -  Patients with severe respiratory, hepatic or renal failure or with any other
             significantly potentially disabling abnormality detected during screening

          -  Known hypersensitivity to the tested treatment including active substance and
             excipients.

          -  Patients participating in another study and exposed to any investigational therapy
             within the 30 days prior to the entry in this study.

          -  Patient without medical care insurance
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.


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