The research aims to answer the following questions:- Are the concentrations of neopterin, amino acids, HVA, S-100B and BDNF in the blood of patients with Alzheimer's disease differ from those in a matched healthy controls group (matched for…
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Descriptives (gender, age, education level, demographics)
- Biochemical biomarkers: neopterin, total amino acid spectrum, HVA, BDNF and
S-100B
- Comorbidity (CIRS-G)
- Drug use
- MMSE score, neuropsychological examination and MRI cerebrum
- The Clinical Dementia Rating (CDR) scale
- Evolution: intercurrent diseases
Secondary outcome
nvt
Background summary
In previous studies, Neopterin plasma concentrations, a marker of cell-mediated
immune activation and
inflammation, were found to be higher in AD patients as compared to the healthy
age-matched controls
(Leblhuber et al, 1999; Hull et al, 2000). Blasko et al (2007) have found a
correlation between neopterin
concentrations and the cognitive decline in patients with AD. Also in patients
with Down syndrome (DS) the
value of neopterin in the blood showed to be significantly increased in DS
patients with AD compared to DS
patients without AD (Coppus et al, 2009). A follow-up study of DS patients
showed that the concentrations of
nearly all amino acids in DS subjects with AD differed significantly from those
of healthy controls, the production
of Nitric Oxide (NO) related amino acids as reflected by an increased
citrulline/arginine ratio (Cit/Arg ratio) was
enhanced during development of clinical dementia and this correlated to
Neopterin plasmaconcentrations.
Furthermore, it was found that neurotrophic proteins play a crucial role in
cognition, learning and memory formation
because they modulate synaptic plasticity. The neurotrophic protein
Brain-derived neurotrophic factor (BDNF) plays
an important role in the changes of cognition and plasticity witch found in AD
(Hubka et al, 2006). The neurotrophic
protein S-100B is involved in degeneration of the central nervous system in AD.
Study objective
The research aims to answer the following questions:
- Are the concentrations of neopterin, amino acids, HVA, S-100B and BDNF in the
blood of patients with Alzheimer's
disease differ from those in a matched healthy controls group (matched for age,
sex, education and comorbidity).
- What is the diagnostic value (sensitivity, specificity, positive predictive
value) of these biomarkers and combinations
of these biomarkers for AD diagnosis?
- Do the AD biomarker values similar to those of AD in Down syndrome patients
or they are different?
Study design
In 50 patients diagnosed with "probable Alzheimer's" (AD), according to the
NINCDS-ADRDA criteria
(CBO guideline Dementia), and in 50 healthy subjects (matched on age, sex,
education and comorbidity),
blood samples will be taken in VieCuri Medical Center in Venlo to determine the
following biomarkers
concentration: neopterin, total amino acid spectrum, HVA, BDNF and S-100B. In
the healthy control group
MMSE is required before the blood test to detect the cognitive state.
Study burden and risks
The risk of complications related to venipuncture are negligible
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Patient inclusion criteria:
- Patients with Alzheimer's disease
- Mentally competent AD patient [Clinical Dementia Rating (CDR) scale 1]
- The diagnosis of "probable Alzheimer's disease* should be made according to the NINCDS-
ADRDA criteria.
- Patients or carers should agree with the study (written informed consent is required form
patients or their carers).;Inclusion criteria control group (healthy subjects in group A):
- Men or women without cognitive or psychiatric disorders
- Mini-Mental State Examination (MMSE) score >= 28
Exclusion criteria
Patient exclusion criteria:
- Mentally incompetent AD patient [Clinical Dementia Rating (CDR) scale 2 and 3]
- Patients with infection or inflammatory disease less than 1 months ago.
- Patients with active malignancy.
- Patients with autoimmune disease (e.g. temporal arteritis, polymyalgia rheumatica).
- Patients who use immune modulating drugs (e.g. Immunocyanin, interferon gamma, immunoglobulin).
- Patients with renal dysfunction (MDRD <50)
- Patients with liver impairment
- Patients with decreased serum albumin <25 g / l;Exclusion criteria control group:
- Conform the patient exclusion criteria
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31507.091.10 |