Identification of Proteostasis-related Biomarkers in Alzheimer´s Dementia

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02686554
• Other study ID #: BIH_CRG2a_TP5
• Status: Recruiting
• Start date: January 2016
• Est. completion date: December 2022

Study information

• Verified date: February 2022
• Source: Charite University, Berlin, Germany
• Contact: Oliver Peters, MD
• Phone: +4930450517628
• Email: oliver.peters[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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").

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

Diagnosis of Alzheimer´s Disease

Exclusion Criteria:

Other neurological or psychiatric diseases Stroke

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Other:
• Neuropsychological assessment
The patients perform tests to assess their cognitive abilities

Locations

Country	Name	City	State
Germany	Charité University Medicine	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Performance	performance in the ADAS cog test battery	3-5 years
Secondary	Biomarker	changes in the concentrations of biomarkers over time	3-5 years