E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Alzheimer's disease |
Alzheimerova choroba |
|
E.1.1.1 | Medical condition in easily understood language |
Alzheimer's disease |
Alzheimerova choroba |
|
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 | 19.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10001897 |
E.1.2 | Term | Alzheimer's disease (incl subtypes) |
E.1.2 | System Organ Class | 100000004852 |
|
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 aim of this trial is to find sufficiently sensitive and reproducible method for determining the drug in biological samples (plasma and cerebrospinal fluid). |
Hlavním cílem je najít dostatečně citlivou a repordukovatelnou metodu stanovení léčiva v biologických vzorcích ( plasma, mozkomíšní mok ). |
|
E.2.2 | Secondary objectives of the trial |
Subsequent use of this method in preclinical and clinical studies. |
Následné využití této metody v preklinických a klinických studiích. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. The opatients who regularly use a standard therapeutic dose of memantine (10mg / day) for at least three months prior to sample collection. 2. A sample of cerebrospinal fluid was collected using lumbar puncture atraumatic needle. 3. Diagnosing probable AD was established in accordance with the criteria NINCDS-ADRDA. |
1. Pacienti, kteří pravidelně používají standardní terapeutickou dávku donepezilu (10mg/den) po dobu nejméně tří měsíců před odběrem vzorku. 2. Vzorek mozkomíšního moku byl odebrán lumbální punkcí pomocí atraumatické jehly. 3. Diagnóza pravděpodobné AD byla stanovena v souladu s kritérii NINCDS-ADRDA.
|
|
E.4 | Principal exclusion criteria |
Only inclusion criteria. |
Žádná vylučující kritéria. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The aim of this trial is to find sufficiently sensitive and reproducible method for determining the drug in biological samples (plasma and cerebrospinal fluid). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After collection of all samples. |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
After collection of all samples. |
|
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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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.8.5 | 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 | No |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |