E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Alzheimer's Disease
Enfermedad de Alzheimer
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001896 |
E.1.2 | Term | Alzheimer's disease |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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].
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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].
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Health Outcomes Assessments |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 28 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |