ESTUDIO DE EXTENSIÓN A LARGO PLAZO, MULTICÉNTRICO, ALEATORIZADO Y EN DOBLE CIEGO, PARA DETERMINAR LA SEGURIDAD, LA TOLERABILIDAD Y LA EFICACIA PRELIMINAR A LARGO PLAZO DE LECOZOTAN (SRA-333) SR EN PACIENTES CON ENFERMEDAD DE ALZHEIMER DE GRADO LEVE A MODERADOA MULTICENTER, RANDOMIZED, DOUBLE-BLIND, LONG-TERM EXTENSION STUDY TO DETERMINE THE SAFETY, TOLERABILITY, AND PRELIMINARY LONG TERM EFFICACY OF LECOZOTAN (SRA-333) SR IN PATIENTS WITH MILD TO MODERATE ALZHEIMER’S DISEASE
- Conditions
- Enfermedad de AlzheimerAlzheimer's Disease
- Registration Number
- EUCTR2005-001476-13-ES
- Lead Sponsor
- Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
1. Patient has completed Week 12 evaluations of study 3098B1-201-EU [EudraCT No. 001475-35] (no early completions) and been compliant.
2. Patient has MMSE =12 and, in the judgment of the investigator, there has been no clinically significant cognitive deterioration since enrollment in study 3098B1-201-EU.
3. Able to give signed and dated written informed consent in accordance with local regulations. The patient’s caregiver will also consent to participate in the study.
4. Able to participate in all scheduled evaluations and complete all required tests.
5. In the opinion of the investigator, the patient and caregiver will be compliant and have a high probability of completing the study.
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
1. Any clinically significant abnormality in physical examination, vital signs, adverse events, electrocardiogram (ECG) or clinical laboratory test results, observed at the baseline visit (week 12 of the double-blind active phase of study 3098B1-201-EU), that, in the judgment of the investigator, is likely to deteriorate or affect the patient’s safety or ability to complete the study.
2. Use of medications for cognitive enhancement, including memantine, cholinesterase inhibitors, or other prohibited medications as per protocol 3098B1-201-EU [EudraCT No. 2005-001475-35].
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary Objective: <br>To evaluate the safety and tolerability of long-term therapy with three dose levels of Lecozotan (SRA-333) SR (2, 5, 10 mg daily) administered to patients with mild to moderate Alzheimer’s Disease who have completed Week 12 evaluations of study 3098B1-201-EU [EudraCT No. 2005-001475-35].<br><br>;Secondary Objective: The secondary objectives are to evaluate the preliminary efficacy of long-term treatment with Lecozotan SR and to measure quality of life in patients with mild to moderate Alzheimer’s Disease and effort levels of care providers.;Primary end point(s): The primary objective of the study is to assess the safety and tolerability of long-term therapy with lecozotan SR. Listings and summary tabulations of adverse events and treatment-emergent adverse events (TEAEs) will be generated. Adverse events will be classified by body system and preferred term. Summaries of the number of patients with events will be provided by each treatment group.
- Secondary Outcome Measures
Name Time Method