Identification of Proteostasis-related Biomarkers in Alzheimer´s Dementia

• Conditions: Alzheimer Disease
• Interventions: Other: Neuropsychological assessment

• Registration Number: NCT02686554
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-16
• Study First Submitted QC: 2016-02-16
• Study First Posted: 2016-02-19
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-02
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Diagnosis of Alzheimer´s Disease

Exclusion Criteria

Other neurological or psychiatric diseases Stroke

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AD patients	Neuropsychological assessment	-
AD patients immunized	Neuropsychological assessment	-

Primary Outcome Measures

Name	Time	Method
Cognitive Performance	3-5 years	performance in the ADAS cog test battery

Secondary Outcome Measures

Name	Time	Method
Biomarker	3-5 years	changes in the concentrations of biomarkers over time

Trial Locations

Locations (1)

Charité University Medicine; 🇩🇪 Berlin, Germany