Identification of Proteostasis-related Biomarkers in Alzheimer´s Dementia

NCT ID: NCT02686554

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2022-12-31

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.

Conditions

Alzheimer Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

AD patients

Neuropsychological assessment

Intervention Type: OTHER

The patients perform tests to assess their cognitive abilities

AD patients immunized

Neuropsychological assessment

Intervention Type: OTHER

The patients perform tests to assess their cognitive abilities

Interventions

Neuropsychological assessment

The patients perform tests to assess their cognitive abilities

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Diagnosis of Alzheimer´s Disease

Exclusion Criteria

Other neurological or psychiatric diseases Stroke

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Oliver Peters, MD

MD, senior resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oliver Peters, MD

Role: PRINCIPAL_INVESTIGATOR

Charité University Medicine, Psychiatry, CBF

Locations

Charité University Medicine

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Oliver Peters, MD

Role: CONTACT

oliver.peters@charite.de

+4930450517628

Facility Contacts

Oliver Peters, MD

Role: primary

oliver.peters@charite.de

+4930450517628

Other Identifiers

BIH_CRG2a_TP5

Identifier Type: -

Identifier Source: org_study_id