Pilot Study Assessing the Effects of PXT00864 in Patients With Mild Alzheimer Disease (AD) (PLEODIAL-I)
Alzheimer Disease
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring PXT00864, mild AD, phase 2a
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
Sites / Locations
- CMRR
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
PXT00864 Dose 1
PXT00864 Dose 2
PXT00864 Dose 3
Placebo of PXT00864
1 orange capsule containing 0.4 mg of acamprosate , and 1 white capsule containing 6 mg of baclofen These 2 capsules are taken orally b.i.d. during 8 weeks.
1 orange capsule containing 1 mg of acamprosate , and 1 white capsule containing 15 mg of baclofen . These 2 capsules are taken orally b.i.d. during 8 weeks.
1 orange capsule containing 20 mg of acamprosate , and 1 white capsule containing 12 mg of baclofen . These 2 capsules are taken orally b.i.d. during 8 weeks.
1 orange capsule containing placebo of acamprosate , and 1 white capsule containing placebo of baclofen . These 2 capsules are taken orally b.i.d. during 4 weeks