E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Early, mild dementia of the Alzheimer’s Type and therapy-refractory Major Depression |
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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 | 10012271 |
E.1.2 | Term | Dementia Alzheimer's type |
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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 | 10066555 |
E.1.2 | Term | Chronic depression |
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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 |
1) Safety 2) First evidence of efficacy: - Cognitive improvement, outlasting months of an EPO treatment-free period (measured by neuropsychological testing) |
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E.2.2 | Secondary objectives of the trial |
- improvement of affective symptoms (mood) - improvement of quality of life - improvement of global functioning - improvement of activities of daily living - improvement of motor performance - improvement/change of facial/emotional expression - relative increase/reduced decrease in total grey matter measured in defined regions of interest - reduction in biochemical damage markers
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
For patients with Alzeimer's Dementia: - Diagnosis of a dementia of the Alzheimer’s Type (DSM-IV) with an initial MMST score 20-26 - Age >40 to 70 years - Close relative(s) available For patients with Major Depression: - Diagnosis of recurrent Major Depression (DSM-IV) with an initial HAMD score ≥ 18 - Age >18 to 70 years - no or inadequate response to two or more adequate trials of different classes of conventional antidepressants, each tried for at least 2-3 months (i.e. therapy- refractory MD) General eligibility criteria for both patient groups: - Both genders - Outpatients - Written informed consent, full contractual capability, authorization of release and use of protected health information - Stable medication for at least 4 weeks prior to inclusion and during follow-up |
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E.4 | Principal exclusion criteria |
- Diagnosis of dementia due to (other) medical conditions (in patients with Major Depression: previous diagnosis of any dementia) - Diagnosis of psychotic, bipolar or post-traumatic stress disorders - Dependence on or abuse of drugs (including benzodiazepines and alcohol) - Acute suicidal tendencies - Diagnosis of a neurological or other severe disease (e.g. myeloproliferative disorder, malignancies, polycythemia) - Renal failure (i.e. dialysis-dependent) - Prior EPO treatment - Major surgery within 4 weeks prior to inclusion - Increased thrombembolic risk - Smoking - Continuous medication of sex hormones/contraceptives - Initial hematocrit >50% (males) or >48% (females) - Untreated or not sufficiently treated arterial hypertension - MRI contraindications - Known allergy or antibodies against erythropoietin |
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E.5 End points |
E.5.1 | Primary end point(s) |
1) Safety: (serious) adverse events, blood parameters, vital signs (especially blood pressure) 2) First evidence of efficacy: - Cognitive functions (measured by neuropsychological testing): global cognitive functioning, speed of processing, attention, visuo-spatial/visuo-constructive functions, executive functions (including working memory), learning and memory - affective symptoms (measured by psychopathological rating scales): depressive symptoms (HAMD), negative, positive and general symptoms (PANSS) |
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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 | 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 | 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 | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Yes |
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 | 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 | No |
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 | No |
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 | 8 |
E.8.9.1 | In the Member State concerned days | 0 |