Measurements of drug concentration in the blood for anti-dementia drugs, in order to improve efficacy and reduce side-effects

Phase 1

• Conditions: MedDRA version: 20.0Level: PTClassification code 10012271Term: Dementia Alzheimer's typeSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10067889Term: Dementia with Lewy bodiesSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10075174Term: Mixed dementiaSystem Organ Class: 10029205 - Nervous system disorders; Dementia in Alzheimers Disease, Parkinsons Disease and Dementia with Lewy Bodies; MedDRA version: 20.0Level: LLTClassification code 10012284Term: Dementia due to Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-002707-10-DK
• Lead Sponsor: Regional Dementia Research Centre, Dept of Neurology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-03
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Dementia in Alzheimers Disease, Parkinsons Disease and Dementia with Lewy Bodies in treatment with either donepezil or memantin
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

Patients without relatives, or living alone. Patients with no ablility to cooperrate. Patients not able to give consent. Patients with primary psychiatric condition. Patients with other medical or neurological conditions which may by themselves explain dementia symptoms. Patients treated with anti-psychotics during past 3 months. Patients with alcohol or drug abuse. Patients receiving ECT within past 3 months. Anaestesia within past 3 months.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether serum-monitoring of anti-dementia drugs may reduce side-effects and improve clinical efficacy and patient compliance. ;Secondary Objective: To investigate eatiology of diverse serum-concentrations, including genetics;Primary end point(s): Last patient in cohorte (app.-110 patients) finishes 1-year follow-up;Timepoint(s) of evaluation of this end point: look above

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: na