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Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00007914
Date of registration:	25/03/2015
Prospective Registration:	No
Primary sponsor:	Landesnervenklinik Wagner-Jauregg
Public title:	Immuneactivation in neurodegenerative diseases
Scientific title:	Immuneactivation in neurodegenerative diseases
Date of first enrolment:	01/01/2006
Target sample size:	50
Recruitment status:	Complete
URL:	http://drks.de/search/en/trial/DRKS00007914
Study type:	interventional
Study design:	Allocation: Non-randomized controlled study; Masking: Open (masking not used); Control: Other; Assignment: parallel; Study design purpose: basic science
Phase:	N/A

Countries of recruitment
Austria

Contacts

Name:	Paulus Rommer
Address:	Währinger Gürtel 18-20 1090 Wien Austria
Telephone:	043 1 40400 31170
Email:	paulus.rommer@meduniwien.ac.at
Affiliation:	Medizinische Universität WienUniversitätsklinik für Neurologie

Name:	Joachim Greilberger
Address:	Harrachgasse 21/II 8010 Graz Austria
Telephone:	0043 316 3804173
Email:	joachim.greilberger@medunigraz.at
Affiliation:	Medizinische Universität GrazInstitut for physiologische Chemie

Key inclusion & exclusion criteria

Inclusion criteria: Patients:
Criteria for Alzheimers disease (NINDS ADRDA) and mild cognitive impairment (Petersen et al).

controls:
age above 18, healthy controls
Exclusion criteria: for all:
Psychiatric diseases (other then dementia)
metabolic diseases
Neurodegenerative diseases other then dementia
Vitaminsupplementation for the last 6 weeks

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

F00
F03

Dementia in Alzheimer disease

Unspecified dementia

Intervention(s)

Group 1: Patients with dementia (either Alzheimer`s disease or MCI): Beneuran compositum tablets (50mg vitamin B1, 50 mg vitamin B6, 5mg folic acid and 0.05mg vitamin B12) 1 tablet/d for one month, afterwards 3 tablets/d for one months,
followed by 2 tablets three times a day for one months (month 3)
Group 2: controls do not receive vitamin supplementation

Primary Outcome(s)

Explorative study.

primary outcomes:
levels of immuneactivation between subgroups at baseline and after three months

(determination as described in pubished trials)

Secondary Outcome(s)

Correlation between clinical parameters (mini mental status examination) and laboratory markers (neopterin, folic acid, malondialdehyde, kynureine, vitamin b12, tryptophan, carbonyl proteins) at baseline and after three months of supplementation

Secondary ID(s)

Source(s) of Monetary Support

Landesnervenklinik Wagner-Jauregg Linz

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 21/12/2005
Contact:

Ethikkommission des Landes Oberösterreich Landesnervenklinik Wagner-Jauregg [Ethikkommission des Landes Oberösterreichs]

Results

Results available:
Date Posted:
Date Completed:	31/12/2006
URL:	http://drks.de/search/en/trial/DRKS00007914#studyResults

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