Alzheimer's Disease
Conditions
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of probable AD according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) criteria. 2. Concurrent use of cholinesterase inhibitors is required and must be administered at a stable dose for 3 months before the baseline visit. The patient should be free of any clinically significant adverse event (AE) attributable to the cholinesterase inhibitor. The patient and the caregiver must agree that, barring unforeseen circumstances, the patient will continue the same dose regimen for the duration of the study. 3. Men and postmenopausal or surgically sterile women aged 50 years or older. Postmenopausal women must have had 12 months of spontaneous amenorrhea. Surgically sterile women are defined as those who have had a hysterectomy, bilateral ovariectomy (oophorectomy), or bilateral tubal ligation. 4. Mini-Mental State Examination (MMSE) score of 12 to 26. 5. Rosen Modified Hachinski Ischemic score ==65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Significant neurologic disease other than AD that may affect cognition (eg, epilepsy, Parkinson disease) or ability to complete the study. 2. Current diagnosis of a major depressive disorder or other major psychiatric symptom according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision (DSM IV-TR), criteria 3. Current clinically significant systemic illness that, in the judgment of the investigator, is likely to deteriorate or affect the patient’s safety, influence a cognitive assessment, or affect the ability to complete the study. 4. History of seizure except febrile childhood seizures. 5. History of clinically evident stroke or clinically significant carotid or vertebrobasilar stenosis or plaque. 6. Myocardial infarction within the last 3 months. 7. History of cancer within the last 5 years, with the exception of nonmetastatic basal and/or squamous cell carcinoma of the skin. 8. Excessive smoking (greater than 20 cigarettes a day). 9. History of alcohol or drug dependence within the last 1 year. 10. Hamilton Psychiatric Rating Scale for Depression Scale (21 item) score > 17. 11. Any clinically significant abnormality in physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that in the judgment of the investigator, is likely to deteriorate or affect the patient’s safety or ability to complete the study. 12. History of any clinically important multiple drug allergies that will compromise the patient’s safety during the study. 13. Use of prescription or nonprescription medications (such as herbals) for cognitive enhancement, except the use of cholinesterase inhibitors or memantine within 3 months before the baseline visit. 14. Any use of experimental drugs or procedures, including experimental medications for AD, within 30 days of baseline visit. 15. Current use of anticonvulsant, anti-Parkinson, antipsychotic, or any antidepressant medications or buspirone within 30 days of baseline visit (except for fluoxetine, which is excluded within 60 days of baseline). 16. Regular use of narcotic medications within 30 days of the baseline visit. 17. Treatment with strong inhibitors of the cytochrome P450 3A4 isoenzyme system (ie, ketoconazole, itraconazole, erythromycin, clarithromycin) within 1 week of baseline visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objective is to measure the responsiveness of patient- and caregiver-reported outcomes instruments.;Primary end point(s): The primary endpoints are the change from baseline in ADAS-Cog and ADCS-CGIC at week 24.;Main Objective: The primary objective is to determine the safety, tolerability, and efficacy of 3 doses of lecozotan SR (2 mg, 5 mg and 10 mg per day) in combination with a cholinesterase inhibitor in patients with mild to moderate Alzheimer's Disease over 24 weeks. | — |
Countries
Finland, Italy, Spain, United Kingdom
Outcome results
None listed