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IGF and Other Neurotrophic Factors in Patients With Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02271750
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : December 8, 2015
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

The global prevalence of dementia is close to 36 million (2010). Furthermore the number is predicted to double in the next 20 years, primarily due to the demographic ageing. A perspective that will challenge the current healthcare systems and national economies.

Dementia is characterized by progressive deterioration in cognition, function and behavior that is sufficiently severe to compromise social and occupational functioning.

The pathogenesis of dementia remains elusive. Thus, there is a need to increase our understanding of the mechanisms leading to the most common forms of dementia. A better understanding of the disease may enable an earlier diagnosis and importantly, a causal treatment of Alzheimer as opposed to the merely symptomatic options available to day.

An experiment with rats and memory might already have taken the first step towards this. The experiment has demonstrated that administration of IGF-II to rats significantly enhances memory retention and prevents forgetting. Furthermore inhibitory avoidance learning leads to an increase in the hippocampal expression of IGF-II. Finally, yet importantly, injections of recombinant IGF-II into hippocampus after training or memory retrieval significantly enhance memory retention and prevent forgetting.

The spinal fluid and the serum will be analysed at the Medical Research Laboratory. The immunological concentrations of IGF-I and -II are measured by validated in-house analyses. Furthermore, Aarhus University Hospital has a unique technique, whereby it is possible to measure the bioactivity of IGF-I and -II in the cerebrospinal fluid. The concentrations of NGF, BDNF and sCD-163 in spinal fluid and serum will be analysed by already established techniques.

The purpose of this study is therefore to define the concentration and biological activity of IGF-I, IGF-II, BDNF, NGF and sCD-163 in the cerebrospinal fluid and serum in patients with Alzheimer's compared with controls.


Condition or disease Intervention/treatment
Dementia Procedure: lumbar puncture

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Study Type : Observational
Actual Enrollment : 120 participants
Official Title: A Study of Insulin-like Growth Factors and Other Neurotrophic Factors in the Cerebrospinal Fluid From Patients With Dementia
Study Start Date : October 2014
Actual Primary Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Group/Cohort Intervention/treatment
Dementia Procedure: lumbar puncture
for spinal fluid

controls Procedure: lumbar puncture
for spinal fluid




Primary Outcome Measures :
  1. Concentration and/or activity of IGF-I in cerebrospinal fluid. [ Time Frame: day 1 ]
    People with dementia compared with controls

  2. Concentration and/or activity of IGF-II in cerebrospinal fluid. [ Time Frame: day 1 ]
    People with dementia compared with controls

  3. Concentration of NGF in cerebrospinal fluid. [ Time Frame: day 1 ]
    People with dementia compared with controls

  4. Concentration of BDNF in cerebrospinal fluid. [ Time Frame: day 1 ]
    People with dementia compared with controls

  5. Concentration of sCD163 in cerebrospinal fluid. [ Time Frame: day 1 ]
    People with dementia compared with controls


Biospecimen Retention:   Samples Without DNA
spinal fluid and blood sample for identification of different factors


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
dementia
Criteria

Inclusion Criteria:

  • dementia, controls(lumbar puncture at our department)

Exclusion Criteria:

  • <18år
  • other CNS disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271750


Locations
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Denmark
Department of Neurology
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Additional Information:
Publications:
Holmes, Clive: Dementia: Medicin(United Kingdom), 2012, Vol. 40, part 11, p. 628-631

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02271750    
Other Study ID Numbers: Dementia IGF
1-10-72-250-14 ( Registry Identifier: The National Committee on Health Research Ethics (Denmark) )
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: October 2014
Keywords provided by University of Aarhus:
IGF, Neurotrophic factors, Dementia, spinal fluid
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders