Identification of Proteostasis-related Biomarkers in Alzheimer´s Dementia

Study Overview
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Brief Summary
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At the time of biomarker-substantiated diagnosis for a given AD patient it remains unclear to what extent the disease will devastate cognitive abilities within the next years. This is not only unsatisfying for the patient and the attending physician but also a major problem in the context of clinical trials that aim to establish new therapeutic agents. In clinical trials it is critically important to foresee as precisely as possible the course of the disease. The overall aim of the subproject is to identify a panel of CSF biomarkers to further improve specificity of diagnosis (disease markers), to measure disease activity and to predict AD progression (stage and progression markers).

Detailed Description
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Within the last years, protein analyses of Aβ-species in the cerebrospinal fluid (CSF) and amyloid-imaging using F18-based PET-tracers have become a part of the diagnostic repertoire in specialized memory clinics allowing a neurobiological, biomarker-based validation of Alzheimer´s disease (AD) diagnosis. This has led to a substantial increase in the specificity of the diagnostic procedure. However, the problem remains that the diverse factors, which influence disease progression are largely unknown, while tools for diagnosis have improved substantially. We will identify patients for participation in a long-term clinical follow up study. Biomaterial (CSF, blood) will be obtained at baseline and subjected to a detailed protein analysis. In a subset of patients, a lumbar puncture will be repeated to compare baseline and follow up CSF. Within this study, a panel of proteins, comprising Aβ- and Tau-species as well as inflammation, glial and synaptic markers, potentially involved in disease progression will be measured in biomaterial from baseline and from follow up assessment. Clinical data will be correlated with the panel of disease and progression markers.

Official Title
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Elucidating the Proteostatis Network to Control Alzheimer's Disease - Identification of Proteostasis-related Biomarkers in Alzheimer´s Dementia

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Other: Neuropsychological assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Alzheimer´s Disease Exclusion Criteria: Other neurological or psychiatric diseases Stroke

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AD patients<br> | Other: Neuropsychological assessment<br>* The patients perform tests to assess their cognitive abilities<br>|
| AD patients immunized<br> | Other: Neuropsychological assessment<br>* The patients perform tests to assess their cognitive abilities<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Performance | performance in the ADAS cog test battery | 3-5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker | changes in the concentrations of biomarkers over time | 3-5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarker