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

Serum-monitoring of anti-dementia drugs, and the relevance to side-effects, clinical efficacy and compliance

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002707-10-DK

Enrollment

110

Registered

2017-11-03

Start date

2018-04-10

Completion date

Unknown

Last updated

2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia in Alzheimers Disease, Parkinsons Disease and Dementia with Lewy Bodies MedDRA version: 20.0 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: LLT Classification code 10012284 Term: Dementia due to Parkinson's disease System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: PT Classification code 10067889 Term: Dementia with Lewy bodies System Organ Clas

Interventions

Trade Name: Memantin Orion Pharmaceutical Form: Tablet INN or Proposed INN: MEMANTINE CAS Number: 19982-08-2 Current Sponsor code: PR1 Concentration unit: mg milligram(s) Concentration type: range Con

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: na	—

Countries

Denmark

Contacts

Public ContactRVD

Regional Dementia Research Centre, Dept of Neurology

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026