Identification of Proteostasis-related Biomarkers in Alzheimer´s Dementia

NCT02686554 | Unknown

• 1 other identifier: BIH_CRG2a_TP5
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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").

Conditions

Alzheimer Disease

Keywords

Biomarker

Outcome Measures

Primary Outcomes (1)

• Cognitive Performance

  performance in the ADAS cog test battery

  3-5 years

Secondary Outcomes (1)

• Biomarker

  3-5 years

Study Arms (2)

AD patients

Other: Neuropsychological assessment

AD patients immunized

Other: Neuropsychological assessment

Interventions

Neuropsychological assessment OTHER

The patients perform tests to assess their cognitive abilities

AD patients; AD patients immunized

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients reporting to a memory clinic

You may qualify if:

• Diagnosis of Alzheimer´s Disease

You may not qualify if:

• Other neurological or psychiatric diseases Stroke

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité University Medicine

Berlin, 10117, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, cerebrospinal fluid, urine

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Oliver Peters, MD

  Charité University Medicine, Psychiatry, CBF

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver Peters, MD

CONTACT

+4930450517628; oliver.peters@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, senior resident

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: February 19, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)