Neurodegenerative DiseasesNCT02222779
Quantification of Transition Metals
An observational study of Neurodegenerative Diseases and Infections, run by University of Cologne at 1 site in Germany.
Trial summary
In this trial, concentrations of transition metals of interest are quantified in surplus cerebrospinal fluid (CSF) and blood serum samples. Quantification of the transition metals will be performed by inductively coupled plasma mass spectrometry (ICP-MS). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurodegenerative Diseases, Infections
- How many people
- 3,000 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to Aug 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: neurodegenerative diseases infections
Who may be able to join
- The trial will include any patient (with various diseases, especially neurodegenerative diseases) who received a lumbar puncture.
Who cannot join
- • The lower age limit is 18 years. In concordance with the objective of the project there is no specific exclusion criteria.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Pharmacology
Cologne, North Rhine-Westphalia, 50829
Uwe Fuhr, Professor, 0049221478 ext. 5230, uwe.fuhr@uk-koeln.de
About this study
Official title: Quantification of Transition Metals in Patients at the Cologne University Hospital
In this trial, concentrations of transition metals of interest are quantified in surplus cerebrospinal fluid (CSF) and blood serum samples. Quantification of the transition metals will be performed by inductively coupled plasma mass spectrometry (ICP-MS). The treating physicians as well as the patients will not be informed about the results of drug concentrations.
Read the detailed description
Samples used include:
Remaining portions of samples collected for diagnostic or therapeutic reasons (paired CSF and blood serum samples). No lumbar puncture will be done specifically for this protocol.
The objective of this study is to gain an overview about transition metals concentrations in blood serum and CSF in order to provide preliminary data on patients. The effect of neurodegenerative diseases on metals or the other way round will be assessed if possible.
- Conditions
- Neurodegenerative Diseases, Infections
- Medical subject headings
- Neurodegenerative Diseases, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Parkinson´s Disease | Not described | |
| Patient´s with Alzheimer´s Disease | Not described | |
| Patients with Multiple Sclerosis | Not described | |
| Patients with any other neurodegenerative diseases | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transition metal concentration
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DiseasesStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohammad Nejad Sigaroudi, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222779
- Sponsor's protocol ID
- KPUK-14-Metal
- Status last verified
- Aug 2014
- First submitted
- 20 Aug 2014
- Last updated
- 21 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Transition Metals in Patients at the Cologne University Hospital
- ClinicalTrials.gov ID
- NCT02222779
- Acronym / sponsor ID
- KPUK-14-Metal
- Conditions
- Neurodegenerative Diseases, Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2019 (estimated)
- First posted
- 21 Aug 2014 (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.
In this trial, concentrations of transition metals of interest are quantified in surplus cerebrospinal fluid (CSF) and blood serum samples. Quantification of the transition metals will be performed by inductively coupled plasma mass spectrometry (ICP-MS). The treating physicians as well as the patients will not be informed about the results of drug concentrations.
Detailed description
Samples used include:
Remaining portions of samples collected for diagnostic or therapeutic reasons (paired CSF and blood serum samples). No lumbar puncture will be done specifically for this protocol.
The objective of this study is to gain an overview about transition metals concentrations in blood serum and CSF in order to provide preliminary data on patients. The effect of neurodegenerative diseases on metals or the other way round will be assessed if possible.
Study design
- Observational model
- Ecologic or community
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with Parkinson´s Disease | – | – |
| Patient´s with Alzheimer´s Disease | – | – |
| Patients with Multiple Sclerosis | – | – |
| Patients with any other neurodegenerative diseases | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- neurodegenerative diseases infections
Key inclusion criteria (1 listed)
- The trial will include any patient (with various diseases, especially neurodegenerative diseases) who received a lumbar puncture.
Key exclusion criteria (1 listed)
- • The lower age limit is 18 years. In concordance with the objective of the project there is no specific exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Transition metal concentration
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2014.
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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.
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 Neurodegenerative Diseases and Infections, run by University of Cologne 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 21 Aug 2014. 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 Uwe Fuhr, Professor (0049221478 ext. 5230, uwe.fuhr@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transition metal concentration (time frame: 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 21 Aug 2014.