Alzheimer's DiseaseNCT00691340
Cellular Proteome From Leukocytes of Glaucoma Patients in Comparison With Patients With Alzheimer's Disease
An observational study of Alzheimer's Disease and Glaucoma, run by University Hospital, Basel, Switzerland.
Trial summary
Glaucoma is a worldwide leading cause of blindness. The key feature of this ocular neuropathy is characterized by an excavating optic nerve head. Loss of retinal ganglion cells is the final end point in blinding diseases of the optic nerve such as glaucoma. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Glaucoma
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Aug 2011
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Glaucoma patients Alzheimer's patients
Who may be able to join
- German native speakers
- Age between 18-85 years
- Primary open-angle glaucoma (POAG) with and without vasospasm
- An inclusion criterion for one control group is Alzheimer's disease.
Who cannot join
- Any history of:
- Ocular or systemic diseases other than glaucoma or Alzheimer's disease
- Drug or alcohol abuse
- Any condition potentially interfering with the visual field results. Visual fields will be obtained from the chart.
- Mental impairment interfering with the ability to cooperate and understand the purpose of this study.
About this study
Official title: Systematic Characterization of the Cellular Proteome From Human Leukocytes of Glaucoma Patients in Comparison With Patients With Alzheimer's Disease
Glaucoma is a worldwide leading cause of blindness. The key feature of this ocular neuropathy is characterized by an excavating optic nerve head. Loss of retinal ganglion cells is the final end point in blinding diseases of the optic nerve such as glaucoma. It is known that neuronal cell death in glaucoma occurs by an apoptotic mechanism. In earlier studies the investigators could demonstrate that the process of apoptosis is reflected in circulating leukocytes by different parameters, like differential mRNA expression and an increased fragmentation of the DNA. Such alterations point out a relationship between cellular stress and apoptotic events.
Based on the results of mRNA-expression the investigators also expect alterations on the protein level.
Read more
This study is, therefore, designed to characterize the proteome related to the proteins involved in cell death related pathways.
Thus, the expression pattern of several proteins in leukocytes from patients with primary open angle glaucoma will be analyzed by techniques like Western-blot and tandem mass spectrometry. These samples will be compared with samples from healthy controls. In addition, they will also be compared with samples from patients with Alzheimer's disease. Since glaucoma is a neurodegenerative disease, these patients will be included as positive controls in this study.
Read the detailed description
Hypothesis:
Differences in the proteome concerning cell death pathways of glaucoma patients correspond to the differences in the mRNA expression of these patients.
Specific aims:
Characterization of the cellular proteome from human leukocytes of glaucoma patients compared to healthy controls and patients with Alzheimer's disease.
Background:
Glaucoma is a worldwide leading cause of blindness. The key feature of this ocular neuropathy is characterized by an excavating optic nerve head. Loss of retinal ganglion cells is the final end point in blinding diseases of the optic nerve such as glaucoma. It is known that neuronal cell death in glaucoma occurs by an apoptotic mechanism. In earlier studies we could demonstrate that this cell death is reflected in circulating leukocytes by different parameters, like differential mRNA expression, and an increased fragmentation of the DNA. The differences in mRNA expression indicate a close relationship to cellular stress conditions and apoptotic events: increased mRNA expression was detected for p53, 20S proteasome alpha subunit, ABC1 transporter, p21(WAF1/CIP1), 14-3-3 sigma factor, MMP-9 and MMP-14, and TIMP-1.
Based on the assumption that glaucoma patients may differ on the level of their expression for these mRNAs, we expect that similar differences should exist at the protein level.
This study is, therefore, designed to characterize the proteome related to the proteins involved in cell death related pathways.
- Conditions
- Alzheimer's Disease, Glaucoma
- Keywords
- POAG, Alzheimer's disease, cellular proteome, human leucocytes, vasospasm, Healthy subjects
- Medical subject headings
- Alzheimer Disease, Glaucoma
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 |
|---|---|---|
| 1 | Control 1 (young subjects) | |
| 2 | Control 2 (old subjects) | |
| 3 | Glaucoma patients | |
| 4 | Alzheimer patients |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: was replaced by another study. Problems with recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bonn
- Responsible party
- Sponsor
- Investigators
- Selim Orguel, MD, Study director, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691340
- Sponsor's protocol ID
- 075-WUK-2008-002
- Status last verified
- Mar 2015
- First submitted
- 3 Jun 2008
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Characterization of the Cellular Proteome From Human Leukocytes of Glaucoma Patients in Comparison With Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00691340
- Acronym / sponsor ID
- 075-WUK-2008-002
- Conditions
- Alzheimer's Disease, Glaucoma
- Keywords
- POAG, Alzheimer's disease, cellular proteome, human leucocytes, vasospasm, Healthy subjects
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: was replaced by another study. Problems with recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University Hospital, Bonn
- Study start
- Jun 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 5 Jun 2008 (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.
Glaucoma is a worldwide leading cause of blindness. The key feature of this ocular neuropathy is characterized by an excavating optic nerve head. Loss of retinal ganglion cells is the final end point in blinding diseases of the optic nerve such as glaucoma. It is known that neuronal cell death in glaucoma occurs by an apoptotic mechanism. In earlier studies the investigators could demonstrate that the process of apoptosis is reflected in circulating leukocytes by different parameters, like differential mRNA expression and an increased fragmentation of the DNA. Such alterations point out a relationship between cellular stress and apoptotic events.
Based on the results of mRNA-expression the investigators also expect alterations on the protein level.
This study is, therefore, designed to characterize the proteome related to the proteins involved in cell death related pathways.
Thus, the expression pattern of several proteins in leukocytes from patients with primary open angle glaucoma will be analyzed by techniques like Western-blot and tandem mass spectrometry. These samples will be compared with samples from healthy controls. In addition, they will also be compared with samples from patients with Alzheimer's disease. Since glaucoma is a neurodegenerative disease, these patients will be included as positive controls in this study.
Detailed description
Hypothesis:
Differences in the proteome concerning cell death pathways of glaucoma patients correspond to the differences in the mRNA expression of these patients.
Specific aims:
Characterization of the cellular proteome from human leukocytes of glaucoma patients compared to healthy controls and patients with Alzheimer's disease.
Background:
Glaucoma is a worldwide leading cause of blindness. The key feature of this ocular neuropathy is characterized by an excavating optic nerve head. Loss of retinal ganglion cells is the final end point in blinding diseases of the optic nerve such as glaucoma. It is known that neuronal cell death in glaucoma occurs by an apoptotic mechanism. In earlier studies we could demonstrate that this cell death is reflected in circulating leukocytes by different parameters, like differential mRNA expression, and an increased fragmentation of the DNA. The differences in mRNA expression indicate a close relationship to cellular stress conditions and apoptotic events: increased mRNA expression was detected for p53, 20S proteasome alpha subunit, ABC1 transporter, p21(WAF1/CIP1), 14-3-3 sigma factor, MMP-9 and MMP-14, and TIMP-1.
Based on the assumption that glaucoma patients may differ on the level of their expression for these mRNAs, we expect that similar differences should exist at the protein level.
This study is, therefore, designed to characterize the proteome related to the proteins involved in cell death related pathways.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Control 1 (young subjects) |
| 2 | – | –Control 2 (old subjects) |
| 3 | – | –Glaucoma patients |
| 4 | – | –Alzheimer patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Glaucoma patients Alzheimer's patients
Key inclusion criteria (4 listed)
- German native speakers
- Age between 18-85 years
- Primary open-angle glaucoma (POAG) with and without vasospasm
- An inclusion criterion for one control group is Alzheimer's disease.
Key exclusion criteria (5 listed)
- Ocular or systemic diseases other than glaucoma or Alzheimer's disease
- Drug or alcohol abuse
- Any condition potentially interfering with the visual field results. Visual fields will be obtained from the chart.
- Mental impairment interfering with the ability to cooperate and understand the purpose of this study.
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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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.
Selim Orguel, MD study director
University Hospital, Basel, Switzerland
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease and Glaucoma, run by University Hospital, Basel, Switzerland.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 10 Mar 2015.