E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Alzheimer's disease is caused by a loss of nerve cells in the brain, particularly in the areas associated with memory and learning. The onset of Alzheimer's also affects the levels of a certain neurotransmitter in the brain. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 4.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10001897 |
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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 of this extension study is to examine the long term effect of treatment with phenserine-tartrate and possibly evaluate the disease modifying potential of phenserine-tartrate. |
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E.2.2 | Secondary objectives of the trial |
To investigate the long term safety profile of phenserine-tartrate. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
After successfully completing the AX-CL-09 study, patients will be enrolled in the extension study and will continue to receive study medication without a break (i.e. rollover directly into the extension study).
In order to be eligible for inclusion in this extension study, patients must have successfully completed the AX-CL-09 study and continue to fulfil the inclusion criteria for the AX-CL-09 study. In addition, patients must fulfil the following: • General health status acceptable for participation in a 6 month extension study; • Are capable of understanding and have given written informed consent for the extension study [or this has been provided by their acceptable representative (according to local requirements)] and a separate caregiver responsibilities and consent form has also been signed by the patient’s caregiver; • Have a reliable caregiver available, and if not living in the same household, the caregiver sees the patient at least 4 times a week or a total of 15 to 20 hours per week; • Agrees to comply with the protocol requirements of the extension study.
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E.4 | Principal exclusion criteria |
Patients who complete the AX-CL-09 study may have received the investigational drug phenserine-tartrate, which is an acetylcholinesterase inhibitor. These patients are eligible for enrolment in the AX-CL-09e extension study providing they have not received any other acetylcholinesterase inhibitor in the 3 months before study entry, and providing they do not fulfil any other exclusion criteria from the AX CL-09 study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The long term efficacy profile will be assessed using the following endpoints
Primary: • Cognitive performance using ADAS-COG.
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | No |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 15 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 15 |