E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
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 |
• To evaluate the safety and tolerability of repeated injections of 150μg CAD106 in AD patients over the 66 weeks of the Extension study. • To evaluate the antibody response of repeated injections of CAD106 as measured by the titers levels of Aβ-specific IgG in serum in AD patients over the 66 weeks of the Extension study.
For a detailed description of the Study objectives, please refer to Section 2 of the enclosed protocol. |
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E.2.2 | Secondary objectives of the trial |
• To evaluate the antibody response of repeated injections of CAD106 as measured by the titers levels of Aβ-specific IgM, Aβ-specific IgG subtypes and Qβ-specific IgG and IgM in serum over the 66 weeks of the Extension study. • To compare the antibody response (Aβ-specific IgG in serum) between the 3 initial CAD106 injections given at 6-week intervals in the Core study and 4 initial CAD106 injections given at 12-week intervals in the Extension study in patients initially treated ith Placebo in the Core study. • To evaluate the antibody response (Aβ-specific IgG in serum) after 4 additional injections in the Extension study in patients initially treated with CAD106 in the Core study.
For a detailed description of the Study objectives, please refer to Section 2 of the enclosed protocol. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients eligible for inclusion in Group 1 of the Open-label extension have to fulfill all of the following criteria:
1. Patients who have completed the Core study with no significant safety concerns. 2. Cooperative, willing to complete all aspects of the Open-label extension and capable of doing so, either alone or with the aid of a responsible caregiver. 3. Residing with someone in the community throughout the Open-label extension or, if living alone, who have daily contact with a primary caregiver. 4. Primary caregiver willing to accept responsibility for assessing the condition of the patient throughout the Open-label extension, and for providing input to safety and tolerability assessments in accordance with all protocol requirements. 5. Able to provide written informed consent and having a responsible caregiver that can provide written assent prior to participation in the Open-label extension. Written informed consent must be obtained before any assessment is performed.
All patients from the Core study not fulfilling Inclusion criteria above will be enrolled in Group 2 : patients of Group 2 will enter directly the 2-year SAE collection phase and no injection with CAD106 will be administered (please refer to the enclosed protocol for all the details). |
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E.4 | Principal exclusion criteria |
Subjects who developed any of the following conditions during the Core study (including results obtained at Week 52) are not eligible for inclusion in Group 1 of the Open-label extension:
1. Diagnosis of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression). 2. Any medical or neurological condition, other than AD, that contributes significantly to the patient’s dementia (e.g., abnormal thyroid function tests, Vitamin B12 or folate deficiency, post-traumatic conditions, Huntington’s disease, Parkinson’s disease, Lyme’s disease, syphilis), including any CSF and/or cerebral MRI findings. 3. CNS inflammation as indicated by: • MRI findings indicative of either meningoencephalitis or of another adverse immune reaction (according to central reader evaluation); • OR signs of inflammation in CSF as defined by clinical judgment and according to ranges from the laboratory used. In most cases in a CSF sample not contaminated by blood, this will be shown by >5 leukocytes/ l, and protein above the age-defined normal range of the laboratory used (e.g. abnormal IgG index, IgG oligoclonal bands). 4. Clinical stroke, intracranial hemorrhage, aneurysms, more than one transitory ischemic attack or unexplained loss of consciousness, or current diagnosis of significant cerebrovascular disease as defined by MRI central reader. 5. Evidence of development of more than two additional cerebral microhemorrhages, defined as a focal T2* hypointensity less than 10 mm in diameter at screening MRI, as identified by MRI central reader. If a MR machine with field strength > 1.5 T is used, higher number of microhemorrhages will be acceptable as defined by the MRI central reader. 6. DSM-IV diagnosis of major depression and/or any other DSM-IV Axis 1 diagnosis that may interfere with the evaluation of the patient’s response to study medication, including other primary neurodegenerative dementia, schizophrenia, or bipolar disorder. 7. Diagnosis of an active, uncontrolled seizure disorder.
For a detailed description of the Exclusion Criteria, please refer to Section 4.2 of the enclosed protocol. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the safety and tolerability of repeated injections of 150μg CAD106 in AD patients over the 66 weeks of the extension study.
For further details, please see Section 2 of the enclosed protocol.
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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 | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | 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) | 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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
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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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 | 3 |
E.8.9.1 | In the Member State concerned days | 14 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |