A double-blind placebo-controlled study of the activity of AVE1625 at doses of 10 mg and 40mg for 12 weeks in patients with mild to moderate Alzheimer s Disease - ND

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-002317-12-IT
• Date of registration: 30/08/2006
• Prospective Registration: No
• Primary sponsor: Sanofi-aventis
• Public title: A double-blind placebo-controlled study of the activity of AVE1625 at doses of 10 mg and 40mg for 12 weeks in patients with mild to moderate Alzheimer s Disease - ND
• Scientific title: A double-blind placebo-controlled study of the activity of AVE1625 at doses of 10 mg and 40mg for 12 weeks in patients with mild to moderate Alzheimer s Disease - ND
• Date of first enrolment: 01/08/2006
• Target sample size: 150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002317-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Italy, Netherlands, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
1- The diagnosis of AD based on the DAT DSM-IV criteria and the INCDS/ADRDA criteria for Probable AD. 2- The diagnosis should also be supported by a Modified Hachinski score 4 and a CT scan/MRI of the brain performed within 12 months prior to randomization that is consistent with the diagnosis of AD. If a patient is followed at the investigational center, had a previous CT scan / MRI scan older than 12 months and has had no focal clinical changes then no new imaging is necessary. 3- Mild to moderate range of severity established by a Mini-Mental State Examination MMSE score 12 e 26 at screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. 50 years of age 2. Severe or unstable cardiovascular, respiratory, renal, hepatic, hematological, endocrinological, neurological or other somatic disease evidenced by history, physical examination, ECG or laboratory tests, which may interfere with the study in the investigator s judgment through interference with the evaluation of the study drug or with the absorption, metabolism or excretion of the study medication . In addition to those abnormalities which in the investigator s judgment are severe or unstable, the following alterations of laboratory tests / ECG findings on the screening must lead to exclusion of the patients a ALT or AST five times the upper limits of the reference range; b serum creatinine 150 mol / L; c neutrophils 1,500/mm3 , and d QTc 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 within two months pri

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Mild to moderate Alzheimer Disease
MedDRA version: 6.1 Level: PT Classification code 10012271

Intervention(s)

Product Code: AVE1625
Pharmaceutical Form: Capsule, soft
CAS Number: 358970-97-5
Current Sponsor code: AVE1625
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use

Primary Outcome(s)

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

Secondary Objective: To evaluate the pharmacokinetic parameters of AVE1625 in patients with mild to moderate Alzheimer Disease

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 ID(s)

ACT10019

2006-002317-12-NL