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Immuneactivation in neurodegenerative diseases

Organizational Data

DRKS-ID:
DRKS00007914
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2015-03-25
Last update in DRKS:
2015-03-25
Registration type:
Retrospective

Acronym/abbreviation of the study

No Entry

URL of the study

No Entry

Brief summary in lay language

The cause for decreasing mental abilities (dementia) is not sufficiently understood so far. Inflammation is at least partly responsible for the maintenance of dementia. The aim of this study is to examine markers for inflammation in patients with dementia in comparison to healthy controls, and if vitamin supplementation will have positive influences on those markers.

Brief summary in scientific language

The critical role of neuro-inflammation and oxidative stress in the pathogenesis of neurodegenerative diseases like Alzheimer`s disease (AD) has become evident. The aim of this study is to assess the influence of vitamin substitution on parameters of oxidative stress, inflammation as well as on MMSE in patients with AD and mild cognitive impairment (MCI). The enrolled participants of this open-label study were healthy controls AD/MCI patients. All participiants received vitamin supplementation for nine months. AD patients were diagnosed following the NINDS ADRDA criteria; MCI patients followed the criteria of Petersen et al. Clinical parameters (MMSE) and laboratory markers (carbonyl proteins, malondialdehyde, tryptophan, kynureine, neopterin, folic acid, vitamin B12 level) were assessed for each subgroup. Assessment of the parameters in the participiants were determined at baseline prior to substitution and after three months. Probands received for one month one tablet/day Beneuran compositum TM (Nycomend Austria GmBH, Linz), followed by three tablets/day for one month, and finally two tablets three times a day for another month. Beneuran compositum tablets contains 50mg vitamin B1, 50 mg vitamin B6, 5mg folic acid and 0.05mg vitamin B12.

Health condition or problem studied

ICD10:
F00 - Dementia in Alzheimer disease
ICD10:
F03 - Unspecified dementia
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 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)
Arm 2:
controls do not receive vitamin supplementation

Endpoints

Primary outcome:
Explorative study. primary outcomes: levels of immuneactivation between subgroups at baseline and after three months (determination as described in pubished trials)
Secondary outcome:
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

Study Design

Purpose:
Basic research/physiological study
Allocation:
Non-randomized controlled study
Control:
  • Other
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Austria
Number of study centers:
Monocenter study
Recruitment location(s):
  • Medical center Landesnervenklinik Wagner-Jaureg Linz Linz;Österreich

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2006-01-01
Planned study completion date:
No Entry
Actual Study Completion Date:
2006-12-31
Target Sample Size:
50
Final Sample Size:
48

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional 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

Addresses

Primary Sponsor

Landesnervenklinik Wagner-Jauregg
Wagner-Jauregg Weg 15
A-4020 Linz
Austria
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Medizinische Universität GrazInstitut for physiologische Chemie
Dr. Prof. Joachim Greilberger
Harrachgasse 21/II
8010 Graz
Austria
Telephone:
0043 316 3804173
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Medizinische Universität WienUniversitätsklinik für Neurologie
Mag Dr Paulus Rommer
Währinger Gürtel 18-20
1090 Wien
Austria
Telephone:
043 1 40400 31170
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Medizinische Universität GrazInstitut for physiologische Chemie
Dr. Prof. Joachim Greilberger
Harrachgasse 21/II
8010 Graz
Austria
Telephone:
0043 316 3804173
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Landesnervenklinik Wagner-Jauregg Linz
Wagner-Jauregg-Weg 15
4020 Linz
Austria
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission des Landes Oberösterreich Landesnervenklinik Wagner-Jauregg [Ethikkommission des Landes Oberösterreichs]
Wagner-Jauregg Weg 15
A-4020 Linz
Austria
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://ooe-ethikkommission.at

Vote of leading Ethics Committee

Date of ethics committee application:
2004-12-06
Ethics committee number:
22
Vote of the Ethics Committee:
Approved
Date of the vote:
2005-12-21

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
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Background literature:
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Related DRKS studies:
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Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
Free Radic Res. 2008 Jul;42(7):633-8. doi: 10.1080/10715760802255764.
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
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Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry