E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Alzheimer's disease |
Malattia di Alzheimer |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012271 |
E.1.2 | Term | Dementia Alzheimer's type |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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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 verify the potential clinical impact of dopaminergic agonists on cognitive functions in patients with mild AD. |
valutare nei pazienti con malattia di Alzheimer in fase iniziale il potenziale impatto clinico degli agonisti dopaminergici (Rotigotina,agonista del recettore D2-like) sulle funzioni cognitive |
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E.2.2 | Secondary objectives of the trial |
to test if rotigotine change brain physiology. We will use multimodal neurophysiological tools such as transcranial magnetic stimulation combined with electroencephalography (TMS/EEG) to measure changes in cortical reactivity in the prefrontal cortex |
Valutare le modifiche indotte dalla terapia dopaminergica sull’attività cerebrale della corteccia prefrontale mediante elettroncefalografia |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All AD patients will have to show a moderate level of dementia, as assessed by a neuropsychological evaluation including the MMSE (ranging from 18 to 24) and a standardized neuropsychological battery (Carlesimo et al,1996) according to criteria NINCDS-ADRDA |
Tutti i pazienti dovranno mostrare un livello moderato di demenza (probabile Malattia di Alzheimer), come accertato dalla valutazione neuropsicologica e da un punteggio al Mini Mental State Examination (MMSE) compreso tra 18 e 24 e in accordo con i criteri NINCDS-ADRDA |
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E.4 | Principal exclusion criteria |
Subjects with CSF values of Aβ1-42 >550 pg/mL will not be included. Subjects will be excluded if they have either two or more hyperintense lesions with a diameter ≥ 10mm or more than eight hyperintense lesions with a diameter between 5 and 9 mm on dual-echo MR images |
Saranno esclusi pazienti con Deficit cognitivi isolati e/o con MMSE (≥25/30); storia di stroke negli ultimi 6 mesi e con scala di Hachinsky >4; evidenza radiologica di lesioni sottocorticali; altri segni e/o sintomi all’esame neurologico; età >80 anni. valori di liquor cerebrospinale di Aβ1-42 > 550 pg/mL
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E.5 End points |
E.5.1 | Primary end point(s) |
Positive effects on general cognitive functions and more specifically on frontal executive functions |
Effetti positivi sulle funzioni cognitive e più specificatamente sulle funzioni esecutive |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Increase of prefrontal cortex activity |
Incremento dell’attività corticale della corteccia prefrontale |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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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at the end of the 24th week of 130's patient |
Al completamento della 24a settimana del paziente 130 |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |