Is P-glycoprotein activity decreased in Alzheimer's disease? A pilot study.

Phase 1

• Conditions: Alzheimer's disease and healthy controls (2 groups: 1 group with young healthy volunteers, 1 group with elderly healthy volunteers); MedDRA version: 16.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-001724-19-AT
• Lead Sponsor: Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-19
• Last Update Posted: 13 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•signed informed consent
•age: =18 years old
•physical examination and laboratory analysis: no presence of clinically relevant abnormal findings or values which the investigator considers may interfere with the objectives of the present study
•no diseases, which the investigator considers may affect the outcome of the study
•ability to comprehend the full nature and purpose of the study, including possible risks and side effects

Patient group (additionally):
•Diagnosis of probable Alzheimer’s disease based on the NINCDS/ADRDA criteria . The severity of AD in a range from mild to moderate, which is in accordance with a MMSE score =12 and =26. The Hachinski score must be <4
•A person who takes care of the patient must agree to accompany the subject to all study procedures
•MRI must support AD diagnosis
•Preferably 11C-PIB® positive scan

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 20

Exclusion Criteria

•Unwillingness to sign the informed consent
•age:<18 years old
•any abnormality found as part of the pre-treatment screening or in any of the laboratory tests performed that the investigators considers to interfere with the objectives of the present study or
•any medication during two weeks before the start of the study, which the investigator considers may affect the validity of the study, due to interference with CYP3A4, Pgp or BCRP (Pgp inductors such as St. John’s wort, rifampicin or inhibitors such as esomeprazole, omeprazole, pantoprazole, lansoprazole, atrovastatin, itraconazole) or may cause potential harm to the subject (e.g. drug-drug interaction between tariquidar and loperamide or quinidine)
•any disease which the investigator considers may affect the outcome of the study
•participation in the evaluation of any drug within four weeks before the start of the study or participation in studies with radiation within 1 year before the start of the study
•inability to comprehend the full nature and purpose of the study
•contraindication for MRI imaging e.g. claustrophobia, metallic endoprosthesis, stent implantation in the last months
•actual vitamin B12 and folic acid deficiency or history of craniocerebral injury
•history of drug or alcohol abuse
•Participation in clinical studies with exposure to radiation exceeding the allowed maximum foreseen by the current guidelines (http://ec.europa.eu/energy/nuclear/radioprotection/publication/doc/136_en.pdf

Patient group (additionally): AD patients with concomitant delirium
•patients with Hachinski score >4, MMSE score out of the range of =12 and =26
•patients and/or caregiver with probable compliance problems

Study & Design

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