Pilot Study Assessing the Effects of PXT00864 in Patients With Mild Alzheimer Disease (AD)
- Registration Number
- NCT02361424
- Lead Sponsor
- Pharnext S.C.A.
- Brief Summary
The purpose of this study is to assess the safety and efficacy on cognitive impairment and functioning of several doses of PXT00864 (new fixed combination of acamprosate and baclofen at low dose) in patients with mild Alzheimer Disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo of PXT00864 placebo 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 PXT00864 Dose 3 PXT00864 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. PXT00864 Dose 1 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. PXT00864 Dose 2 PXT00864 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.
- Primary Outcome Measures
Name Time Method Number of Treatment Emergent Adverse Events (TEAEs) throughout the 12-week study period. Change From Baseline in the total score of the 11-item Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4) Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater cognitive impairment.
- Secondary Outcome Measures
Name Time Method Change From Baseline in the score of the Free and Cued Selective Reminding Test (FCSRT) 1 (baseline) and V4 (end of study, after 12 weeks of treatment) FCSRT is a memory test administered according to the procedure described by Gröber and Buschke modified with 16 verbal items.
Change From Baseline in the time score of the Trail Making Test - part A Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4) Change From Baseline in the time score of the Trail Making Test - part B Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4) Change From Baseline in the score of the Digit Symbol Substitution Test (DSST) Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4) Scores on the DSST range from 0-93 with lower scores indicating greater impairment.
Change From Baseline in the score of the Clinical Dementia Rating (CDR) scale 1 (baseline) and V4 (end of study, after 12 weeks of treatment) The Sum of Boxes score of the CDR ranges from 0 to 18, with higher scores indicating greater impairment.
Change From Baseline in the speed to perform the Zazzo's Cancellation Test Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4) Change From Baseline in the score of the Zazzo's Cancellation Test Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4) Change From Baseline in the score of the 15-second Isaacs Set Test Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4) Change From Baseline in the score of the Apathy Inventory (AI) scale 1 (baseline) and V4 (end of study, after 12 weeks of treatment) Scores on the AI range from 0-12 with higher scores indicating greater impairment.
Change From Baseline in the score of the 4-item Instrumental Activities of Daily Living scale (IADL-PAQUID) V0 (train), V1 (baseline), and every 4 weeks (V2, V3 and V4) The 4-item Instrumental Activities of Daily Living scale (IADL) concerns four routine daily functions (using transportation, managing finances, using the phone and managing medicines use). Scores on the IADL range from 4-15 with higher scores indicating greater impairment.
Trial Locations
- Locations (1)
CMRR
🇫🇷Bordeaux, France