Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pharnext S.C.A.
With
Ascopharm Groupe Novasco
Age
60–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
