Alzheimer's Disease MedDRA version: 8.1 Level: LLT Classification code 10001896 Term: 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. 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
Exclusion criteria
Exclusion criteria: 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].
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: To evaluate the safety and tolerability of long-term therapy with three dose levels (2, 5, 10 mg daily) of Lecozotan (SRA-333) SR 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]. ;Secondary Objective: 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 evaluate the safety and tolerability of long-term therapy with dose levels of lecozotan SR (2 mg, 5 mg or 10 mg per day). 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. A secondary objective of the study is to assess the preliminary efficacy of long-term treatment with lecozotan SR. The mean changes from study 3098B1-201 baseline in ADAS-Cog total, the composite z-score of CDT-CAT, the behavioral NPI total, the functional DAD total, the Cornell total score and the global ADCS-CGIC score will be computed with their 95% confidence intervals for each visit by treatment group. | — |
Countries
Finland, France, Italy, Spain, United Kingdom
Outcome results
None listed