Alzheimer's disease MedDRA version: 20.0 Level: HLT Classification code 10001897 Term: Alzheimer's disease (incl subtypes) System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Landex
Product Name: Landex
Pharmaceutical Form: Tablet
Trade Name: Aricept
Product Name: Aricept
Pharmaceu
Sponsors
Fakultní nemocnice Hradec Králové
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women 50 - 80 (included) years old. 2. Patients who regularly use a standard therapeutic dose of donepezil (10 mg / day) for at least 3 months prior to sample collection. 3. Diagnosis probable AD established in accordance with the criteria NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association). Only patients with mild or moderate dementia who are able to understand the informed consent, will be included. Whether or not the patient is able to give informed consent is based on investigator decision. 4. Subject will be accompanied by a close person (caregiver, family member) to all study visits. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical trial or administration of another investigational product, medical device or procedure within 30 days prior to sample collection. 2. Lumbar puncture contraindication: intracranial hypertension, blood clotting disorders, skin inflammation at the injection site. 3. Investigator decision that participation in this clinical trial is not in the best interests of patient for safety reasons. 4. Pregnant or breastfeeding women can not be enrolled to the study. Given the age of study population this is not expected. However any pregnancy will be excluded on visit D0 by urine pregnancy test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this trial is to find sufficiently sensitive and reproducible method for determining the drug in biological samples (plasma and cerebrospinal fluid).;Secondary Objective: Subsequent use of this method in preclinical and clinical studies.;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).;Timepoint(s) of evaluation of this end point: After collection of all samples. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No secondary endpoints.;Timepoint(s) of evaluation of this end point: After collection of all samples. | — |
Countries
Czech Republic
Contacts
Public ContactClinical Trials Information
Neurologická klinika Fakultní nemocnice Hradec Králové
Outcome results
None listed