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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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23 July 2018 |
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Main ID: |
EUCTR2017-002707-10-DK |
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Date of registration:
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03/11/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Measurements of drug concentration in the blood for anti-dementia drugs, in order to improve efficacy and reduce side-effects
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Scientific title:
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Serum-monitoring of anti-dementia drugs, and the relevance to side-effects, clinical efficacy and compliance |
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Date of first enrolment:
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10/04/2018 |
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Target sample size:
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110 |
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002707-10 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: yes
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Comparing efficacy and side-effects in groups with serum-monitoring vs group with "business as usual
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Denmark
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Contacts
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Name:
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RVD
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Address:
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Vestermarksvej 11
4000
Roskilde
Denmark |
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Telephone:
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Email:
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Affiliation:
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Regional Dementia Research Centre, Dept of Neurology |
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Name:
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RVD
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Address:
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Vestermarksvej 11
4000
Roskilde
Denmark |
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Telephone:
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Email:
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Affiliation:
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Regional Dementia Research Centre, Dept of Neurology |
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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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 Class: 10029205 - Nervous system disorders
MedDRA version: 20.0
Level: PT
Classification code 10075174
Term: Mixed dementia
System Organ Class: 10029205 - Nervous system disorders
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Intervention(s)
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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
Concentration number: 10-20
Product Name: Donepezil Sandoz
Product Code: 25330
Pharmaceutical Form: Tablet
INN or Proposed INN: DONEPEZIL
CAS Number: 120014-06-4
Current Sponsor code: PR2
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5-10
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Primary Outcome(s)
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Primary end point(s): Last patient in cohorte (app.-110 patients) finishes 1-year follow-up
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Secondary Objective: To investigate eatiology of diverse serum-concentrations, including genetics
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Main Objective: To investigate whether serum-monitoring of anti-dementia drugs may reduce side-effects and improve clinical efficacy and patient compliance.
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Timepoint(s) of evaluation of this end point: look above
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Secondary Outcome(s)
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Secondary end point(s): not applicable
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Timepoint(s) of evaluation of this end point: na
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Source(s) of Monetary Support
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Regional Dementia Research Centre, Dept of Neurology
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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