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 24 evaluations of study 3098B1-203-EU (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 3098B1-203-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. Concurrent use of a cholinesterase inhibitor is required and must have been administered at a stable dose during the patient’s participation in study 3098B1-203-EU. 5. Able to participate in all scheduled evaluations and complete all required tests. 6. 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 ;Inclusion criteria: 1. Patient has completed Week 24 evaluations of study 3098B1-203-EU (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 3098B1-203-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. Concurrent use of a cholinesterase inhibitor is required and must have been administered at a stable dose during the patient’s participation in study 3098B1-203-EU. 5. Able to participate in all scheduled evaluations and complete all required tests. 6. 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 clinically 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. 2. Use of medications for cognitive enhancement, except the use of a cholinesterase inhibitors or memantine or other prohibited medications as per protocol 3098B1-203-EU [EudraCT N° 2005-001477-94]. ;Exclusion criteria: 1. Any clinically significant abnormality in physical examination, vital signs, adverse events, electrocardiogram (ECG) or clinically 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. 2. Use of medications for cognitive enhancement, except the use of a cholinesterase inhibitors or memantine or other prohibited medications as per protocol 3098B1-203-EU [EudraCT N° 2005-001477-94].
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the safety and tolerability of long-term therapy with three dose levels (2, 5, 10 mg total daily) of lecozotan SR administered to patients with mild to moderate Alzheimer’s Disease who have completed Week 24 evaluations of study 3098B1-203-EU [EudraCT No. 2005-001477-94]. ;Secondary Objective: 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 this study is to evaluate 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. The number of patients with events will be summarized by body system and preferred term for each treatment group. A secondary objective of the study is to assess the preliminary efficacy of long-term treatment with lecozotan SR. Because of the nature of this study, statistical tests will be exploratory in nature and no claims will be intended. For all the efficacy measures except for ADCS-CGIC, the mean changes from baseline evaluations in study 3098B1-203 along with their 95% confidence intervals will be computed for each treatment group at each visit.;Main Objective: The primary objective is to evaluate the safety and tolerability of long-term therapy with three dose levels (2, 5, 10 mg total daily) of lecozotan SR administered to patients with mild to moderate Alzheimer’s Disease who have completed Week 24 evaluations of study 3098B1-203-EU [EudraCT No. 2005-001477-94]. ;Secondary Objective: 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 | — |
Countries
Finland, France, Italy, Spain, United Kingdom
Contacts
Public Contact; ;
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Outcome results
None listed