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

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