Monitoring of changes in the concentration of donepezil (Alzheimer's disease drug), oxidative stress indicators, and acetylcholinesterase enzyme activity in cerebrospinal fluid and plasma of patients with Alzheimer's disease.

Phase 1

• Conditions: Alzheimer's disease; MedDRA version: 20.0 Level: HLT Classification code 10001897 Term: Alzheimer's disease (incl subtypes) System Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-003586-94-CZ
• Lead Sponsor: Fakultní nemocnice Hradec Králové

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-09
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 32

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified