Mild to moderate Alzheimer Disease
Conditions
Interventions
Product Name: AVE1625
Product Code: AVE1625
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: NA
CAS Number: 358970-97-5
Current Sponsor code: AVE1625
Other descriptive name: NA
Concentration un
Sponsors
Sanofi-aventis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1- The diagnosis of AD based on: the DAT DSM-IV criteria and the NINCDS/ADRDA criteria for Probable AD. 2- The diagnosis should also be supported by: a Modified Hachinski score =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. five times the upper limits of the reference range; (b) serum creatinine > 150 µmol / L; (c) neutrophils 500 ms. 3. Evidence of any other primary central nervous system condition (such as but not limited to Parkinson’s disease, Multi-infarct dementia, or other dementias) 4. Epilepsy 5. Current symptoms of depression at screening, (patients on therapy, if stable for at least 3 months before randomization, with no significant symptoms, are allowed to be included). 6. Evidence of other primary psychiatric condition, which may interfere with the study in the investigator’s judgment 7. Females of childbearing potential. Females of child bearing potential are defined as females who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, bilateral oopherectomy) or are not postmenopausal 8. Potent CYP3A4 inhibitors (ritonavir, itraconaxole, nefazodone, ketoconazole, clarithromycin, telithromycin, troleandomycin, chloramphenicol, cyclosporine, grapefruit juice). 9. Potent CYP2C19 inhibitors (fluvoxamine) and fluconazole. 10. Use of CYP2C9 substrates (sulfonylureas, glitazones, nateglinide, warfarin, losartan, irbesartan, fluvastatin, amytriptiline, fluoxetine, phenytoin, tamoxifen, leflunomid, acenocoumarol, phenprocoumon, hexobarbital, celecoxib) 11. Patients with any of the following: history or presence of blood dyscrasia and bleeding disorder including thrombocytopenia, thrombopathy, hypofibrinogenemia, hemophilia, anemia or known protein S or C deficiency; active or recent (within 3 months of randomization) significant bleeding, including gastrointestinal bleeding or peptic ulcer; laboratory coagulation parameters out of normal ranges: INR (>1.2); or use of anticoagulants or recent treatment with thrombolytic agents 12. Treatment with memantine 13. If treated with a cholinesterase inhibitor any change in therapy or dose in the 3 months prior to randomization 14. If previously treated with an approved theraphy for AD, but not currently treated, any change in therapy in the previous 3 months prior to randomization 15. Recent changes in treatment with atypical antipsychotics (such as clozapine, olanzapine, risperidone, ziprasidone) or expectations of changes during the duration of the study. In general these treatments should have been in use and well tolerated for 3 months prior to randomization with no change in dose in the 3 months prior to randomization. 16. Treatment with typical antipsychotics, tricyclic antidepressants or MAOI antidepressants. If previously administered, the patient should have stopped taking these drugs at least 4 weeks prior to randomization. 17. Participation in another clinical trial with an investigational drug or other investigational intervention with
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the activity of AVE1625 at the doses of 10 and 40 mg/day in comparison to placebo in patients with mild to moderate Alzheimer Disease: - Safety and tolerability by monitoring of adverse events, clinical laboratories, and ECG - Efficacy by evaluation of cognitive, global, and behavioral parameters ;Secondary Objective: To evaluate the pharmacokinetic parameters of AVE1625 in patients with mild to moderate Alzheimer Disease;Primary end point(s): Safety and tolerability: Safety variables include the percentage of patients withdrawn from study drug due to an adverse event, reported adverse events, clinical laboratory values, ECG, neurological evaluation, and vital signs. Adverse events will be collected by spontaneous report, physical examination and neurological assessment, vital sign monitoring, clinical laboratories, and ECG’s. | — |
Countries
Italy, Netherlands, Sweden
Outcome results
None listed