E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 subcutaneous (s.c.) injections of 150μg CAD106 in patients with mild AD over the 52 weeks of the study. |
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E.2.2 | Secondary objectives of the trial |
To determine the Aβ-specific antibody response to CAD106 by means of evaluating titer levels (IgG and IgM) in serum and in CSF; and assessing Qβ-specific antibody response: (IgG and IgM) in serum over the 52 weeks of the study.
To characterize Aβ-specific and Qβ-specific T-cell response in PBMCs from patients receiving CAD106 or placebo over the first 14 weeks of the study. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male and/or female (without childbearing potential) patients between 40 and 85 years old Diagnosis of dementia of the Alzheimer’s type according to the DSM-IV criteria Mild AD as confirmed by MMSE score of 20 to 26 Clinical diagnosis of probable AD established by a Work Group of the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimers’s Disease and Related Disorders Association Primary caregiver willing to assent taking the responsibility for assessing the condition of the patient throughout the study, and for providing input to safety and tolerability assessments in accordance with all protocol requirements, in writing.
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E.4 | Principal exclusion criteria |
Any medical or neurological condition, other than AD, that contributes significantly to the patient’s dementia. History in the past 2 years or current diagnosis of CNS inflammation. History of cerebrovascular disease Current DSM-IV diagnosis of major depression and/or any other DSM-IV Axis 1 diagnosis. History or current diagnosis of an active, uncontrolled seizure disorder. Evidence of inflammation or chronic inflammatory condition Autoimmune disease History of inmunocompromise, hepatitis B or C, myocardial infarction, malignancy of any organ system Vaccinated within 4 weeks before the first study drug injection Treatment with inmunosupressive drugs |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point of this study is to establish the safety and tolerability of repeated injections of 150µg of CAD106, by means of standard safety analysis (laboratory tests, frequency of adverse events, frequency of injection-related reactions..) |
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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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
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 | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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
| |
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 | 1 |
E.8.9.1 | In the Member State concerned days | |