Alzheimer DiseaseNCT02686554
Identification of Proteostasis-related Biomarkers in Alzheimer´s Dementia
An observational study of Alzheimer Disease, run by Charite University, Berlin, Germany at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Neuropsychological assessment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2016to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients reporting to a memory clinic
Who may be able to join
- Diagnosis of Alzheimer´s Disease
Who cannot join
- Other neurological or psychiatric diseases Stroke
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité University Medicine
Berlin, 10117
Oliver Peters, MD, +4930450517628, oliver.peters@charite.de
About this study
Official title: Elucidating the Proteostatis Network to Control Alzheimer's Disease - Identification of Proteostasis-related Biomarkers in Alzheimer´s Dementia
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").
Read the 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
- Being tested
- Neuropsychological assessment
- Keywords
- Biomarker
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological assessmentOther
The patients perform tests to assess their cognitive abilities
| Study group | Role | What they receive |
|---|---|---|
| AD patients | Not described Receives: Other: Neuropsychological assessment | |
| AD patients immunized | Not described Receives: Other: Neuropsychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Performance
performance in the ADAS cog test battery
Measured: 3-5 years
Secondary outcomes (1)
Biomarker
changes in the concentrations of biomarkers over time
Measured: 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliver Peters, MD, Charite University, Berlin, Germany
- Investigators
- Oliver Peters, MD, Principal investigator, Charité University Medicine, Psychiatry, CBF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686554
- Sponsor's protocol ID
- BIH_CRG2a_TP5
- Status last verified
- Feb 2022
- First submitted
- 16 Feb 2016
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating the Proteostatis Network to Control Alzheimer's Disease - Identification of Proteostasis-related Biomarkers in Alzheimer´s Dementia
- ClinicalTrials.gov ID
- NCT02686554
- Acronym / sponsor ID
- BIH_CRG2a_TP5
- Conditions
- Alzheimer Disease
- Keywords
- Biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 19 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AD patients | – | Other: Neuropsychological assessment |
| AD patients immunized | – | Other: Neuropsychological assessment |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients reporting to a memory clinic
Key inclusion criteria (1 listed)
- Diagnosis of Alzheimer´s Disease
Key exclusion criteria (1 listed)
- Other neurological or psychiatric diseases Stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological assessmentThe patients perform tests to assess their cognitive abilities | Other | AD patients, AD patients immunized |
Primary outcome
Cognitive Performance
Time frame: 3-5 years
performance in the ADAS cog test battery
1 secondary outcome
Biomarker
Time frame: 3-5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Peters, MD principal investigator
Charité University Medicine, Psychiatry, CBF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oliver Peters, MD (+4930450517628, oliver.peters@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Performance (time frame: 3-5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.