- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02686554
Identification of Proteostasis-related Biomarkers in Alzheimer´s Dementia
Elucidating the Proteostatis Network to Control Alzheimer's Disease - Identification of Proteostasis-related Biomarkers in Alzheimer´s Dementia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Oliver Peters, MD
- Phone Number: +4930450517628
- Email: oliver.peters@charite.de
Study Locations
-
-
-
Berlin, Germany, 10117
- Recruiting
- Charité University Medicine
-
Contact:
- Oliver Peters, MD
- Phone Number: +4930450517628
- Email: oliver.peters@charite.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Diagnosis of Alzheimer´s Disease
Exclusion Criteria:
Other neurological or psychiatric diseases Stroke
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
AD patients
|
The patients perform tests to assess their cognitive abilities
|
AD patients immunized
|
The patients perform tests to assess their cognitive abilities
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive Performance
Time Frame: 3-5 years
|
performance in the ADAS cog test battery
|
3-5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biomarker
Time Frame: 3-5 years
|
changes in the concentrations of biomarkers over time
|
3-5 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Oliver Peters, MD, Charité University Medicine, Psychiatry, CBF
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIH_CRG2a_TP5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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