NCT02271750

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Last Updated

December 8, 2015

Status Verified

October 1, 2014

Enrollment Period

1.1 years

First QC Date

October 2, 2014

Last Update Submit

December 7, 2015

Conditions

Keywords

IGF, Neurotrophic factors, Dementia, spinal fluid

Outcome Measures

Primary Outcomes (5)

  • Concentration and/or activity of IGF-I in cerebrospinal fluid.

    People with dementia compared with controls

    day 1

  • Concentration and/or activity of IGF-II in cerebrospinal fluid.

    People with dementia compared with controls

    day 1

  • Concentration of NGF in cerebrospinal fluid.

    People with dementia compared with controls

    day 1

  • Concentration of BDNF in cerebrospinal fluid.

    People with dementia compared with controls

    day 1

  • Concentration of sCD163 in cerebrospinal fluid.

    People with dementia compared with controls

    day 1

Study Arms (2)

Dementia

Procedure: lumbar puncture

controls

Procedure: lumbar puncture

Interventions

for spinal fluid

Dementiacontrols

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

dementia

You may qualify if:

  • dementia, controls(lumbar puncture at our department)

You may not qualify if:

  • \<18år
  • other CNS disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology

Aarhus C, 8000, Denmark

Location

Related Publications (12)

  • Holmes, Clive: Dementia: Medicin(United Kingdom), 2012, Vol. 40, part 11, p. 628-631

    BACKGROUND
  • Georges J, Jansen S, Jackson J, Meyrieux A, Sadowska A, Selmes M. Alzheimer's disease in real life--the dementia carer's survey. Int J Geriatr Psychiatry. 2008 May;23(5):546-51. doi: 10.1002/gps.1984.

    PMID: 18232054BACKGROUND
  • Luque FA, Jaffe SL. The molecular and cellular pathogenesis of dementia of the Alzheimer's type an overview. Int Rev Neurobiol. 2009;84:151-65. doi: 10.1016/S0074-7742(09)00408-5.

    PMID: 19501717BACKGROUND
  • Bertram L. Alzheimer's disease genetics current status and future perspectives. Int Rev Neurobiol. 2009;84:167-84. doi: 10.1016/S0074-7742(09)00409-7.

    PMID: 19501718BACKGROUND
  • Hampel H, Lista S, Teipel SJ, Garaci F, Nistico R, Blennow K, Zetterberg H, Bertram L, Duyckaerts C, Bakardjian H, Drzezga A, Colliot O, Epelbaum S, Broich K, Lehericy S, Brice A, Khachaturian ZS, Aisen PS, Dubois B. Perspective on future role of biological markers in clinical therapy trials of Alzheimer's disease: a long-range point of view beyond 2020. Biochem Pharmacol. 2014 Apr 15;88(4):426-49. doi: 10.1016/j.bcp.2013.11.009. Epub 2013 Nov 22.

    PMID: 24275164BACKGROUND
  • Chen DY, Stern SA, Garcia-Osta A, Saunier-Rebori B, Pollonini G, Bambah-Mukku D, Blitzer RD, Alberini CM. A critical role for IGF-II in memory consolidation and enhancement. Nature. 2011 Jan 27;469(7331):491-7. doi: 10.1038/nature09667.

    PMID: 21270887BACKGROUND
  • de la Monte SM, Wands JR. Alzheimer's disease is type 3 diabetes-evidence reviewed. J Diabetes Sci Technol. 2008 Nov;2(6):1101-13. doi: 10.1177/193229680800200619.

    PMID: 19885299BACKGROUND
  • Hoyer S. Causes and consequences of disturbances of cerebral glucose metabolism in sporadic Alzheimer disease: therapeutic implications. Adv Exp Med Biol. 2004;541:135-52. doi: 10.1007/978-1-4419-8969-7_8.

    PMID: 14977212BACKGROUND
  • Bloemer J, Bhattacharya S, Amin R, Suppiramaniam V. Impaired insulin signaling and mechanisms of memory loss. Prog Mol Biol Transl Sci. 2014;121:413-49. doi: 10.1016/B978-0-12-800101-1.00013-2.

    PMID: 24373245BACKGROUND
  • Trueba-Saiz A, Cavada C, Fernandez AM, Leon T, Gonzalez DA, Fortea Ormaechea J, Lleo A, Del Ser T, Nunez A, Torres-Aleman I. Loss of serum IGF-I input to the brain as an early biomarker of disease onset in Alzheimer mice. Transl Psychiatry. 2013 Dec 3;3(12):e330. doi: 10.1038/tp.2013.102.

    PMID: 24301648BACKGROUND
  • Sopova K, Gatsiou K, Stellos K, Laske C. Dysregulation of neurotrophic and haematopoietic growth factors in Alzheimer's disease: from pathophysiology to novel treatment strategies. Curr Alzheimer Res. 2014 Jan;11(1):27-39. doi: 10.2174/1567205010666131120100743.

    PMID: 24251394BACKGROUND
  • Brookmeyer R, Johnson E, Ziegler-Graham K, Arrighi HM. Forecasting the global burden of Alzheimer's disease. Alzheimers Dement. 2007 Jul;3(3):186-91. doi: 10.1016/j.jalz.2007.04.381.

    PMID: 19595937BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

spinal fluid and blood sample for identification of different factors

MeSH Terms

Conditions

Dementia

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BiopsySpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 22, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2015

Last Updated

December 8, 2015

Record last verified: 2014-10

Locations