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 - NA

• Conditions: Mild to moderate Alzheimer Disease

• Registration Number: EUCTR2006-002317-12-SE
• Lead Sponsor: Sanofi-aventis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

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 < 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 and = 26 at screening.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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 µmol / 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 with

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>- Safety and tolerability by monitoring of adverse events, clinical laboratories, and ECG<br>- 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. <br>Adverse events will be collected by spontaneous report, physical examination and neurological assessment, vital sign monitoring, clinical laboratories, and ECG’s.