Multiple SclerosisNCT01250678
Neurocognitive Changes in Patients With Remitting Relapsing Multiple Sclerosis Treated With Natalizumab
An observational study of Multiple Sclerosis and Cognitive Impairment, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial summary
Cognitive impairment is seen in about half of patients with relapsing remitting MS. Our knowledge about long term development of cognitive performance under natalizumab therapy is limited. We want to demonstrate with this study that patients treated with ntz improve in neurocognitive tests over the long term. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Cognitive Impairment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2011to Jun 2014
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: MS-patients will be recruited in the outpatient clinic of the neurology department of the cantonal hospital of Saint Gallen, responsible for treatment of MS patients of Northeast Switzerland.
Who may be able to join
- Patients between 18 and 55 years at presentation
- Diagnosis of relapsing-remitting MS according to revised McDonald criteria 2005
- Patients treated with ntz
- EDSS under 5.5
Who cannot join
- Brain pathology other than MS
- Known history of head trauma
- Pure spinal manifestation of demyelization
- Neuromyelitis optica
- Primary and secondary progressive MS
- Benzodiazepine intake within the last three months
Show all 11Show fewer
- Relapse within the last three months
- Steroid intake within the last three months
- History of severe depressive disorder and/or suicidality, seizure, drug or alcohol abuse
- No informed consent
- Insufficient knowledge of German
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Cantonal Hospital of Saint Gallen
Sankt Gallen, 9007
Murat Yildiz, MD, +41 76 764 ext. 11 11, murat@kssg.ch
Murat Yildiz, MD
About this study
Cognitive impairment is seen in about half of patients with relapsing remitting MS. Our knowledge about long term development of cognitive performance under natalizumab therapy is limited. We want to demonstrate with this study that patients treated with ntz improve in neurocognitive tests over the long term.
Read the detailed description
Impaired cognitive function may represent damage to brain regions that are not involved in physical functions, hence may not be detected during routine neurological assessment. Despite the high prevalence of cognitive impairment in MS, cognitive function is not assessed routinely in clinical practice. The perception that cognitive assessments are costly, time-consuming, complicated, and difficult to administer and interpret has contributed, at least in part, to the failure to incorporate cognitive testing into standard clinical evaluation of patients with MS.
Cognitive impairment may also reduce the ability of patients to comprehend and adhere to treatment concepts (Bobholz 2003). Early detection of cognitive impairment is important to initiate therapeutic intervention, even though the optimal treatment of cognitive decline in MS is at the moment controversial.
Preliminary studies suggest an essential role of disease modifying therapies (DMT) in inhibition of cognitive deterioration in patients with MS (Barak 2002, Flechter 2007). Data about long term cognitive performance of multiple sclerosis patients treated with natalizumab is limited. One study demonstrated in MS patients treated with natalizumab an improvement in SDMT (Symbol Digit Modalities Test) of 16.4% over a period of 2 years (Piehl 2010). SDMT is a screening tool for cognitive impairment in MS patients, mainly measuring working memory and speed processing. As SDMT only covers a part of the neurocognitive impairments seen in MS patients, there is a need for further studies to gain a more complete picture.
- Conditions
- Multiple Sclerosis, Cognitive Impairment
- Keywords
- multiple sclerosis, cognitive impairment, natalizumab, SDMT
- Medical subject headings
- Multiple Sclerosis, Cognitive Dysfunction
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 |
|---|---|---|
| neurocognitive impaired | MS patients treated with natalizumab who at the beginning of the study suffer from cognitive impairment | |
| neurocognitive non-impaired | MS patients treated with natalizumab who at the beginning of the study do not suffer from cognitive impairment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Symbol Digit Modalities Test (SDMT)
SDMT is an easily administered brief screening tool for cognitive dysfunction in MS. Patients view a key presenting nine numbers paired with symbols. Below the key is an array of symbols paired with empty spaces, the patient's task being to voice the matching number for each symbol as rapidly as possible.
Measured: 3 years
Secondary outcomes (3)
Multiple Sclerosis Inventory Cognition (MUSIC)
MUSIC is a cognitive screening instrument. It assesses the cognitive core deficit in MS: mental flexibility, attention, information processing speed, memory and inhibitory control and includes also 3 items derived from a factorial analysis to examine cognitive, motor and psychosocial fatigue, respectively.
Measured: 3 years
TAP subtest Alertness
TAP subtest Alertness measures the subject's ability to respond to a visual stimulus and to increase the attentional level in expectance of a stimulus of high priority. The computer-assisted test is given under 2 conditions: Simple reaction time to a visual stimulus (Greek cross) appearing at randomly varying intervals on the monitor screen is measured. In the second condition, the visual stimulus (= critical stimulus) is preceded by a cue sound presented as warning tone.
Measured: 3 years
Composite neurocognitive index
Overall neurocognitive status will be assessed with a composite cognitive index score representing the sum of the scores for the individual tests: TAP subtest Alertness, MUSIC and SDMT.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Investigators
- Murat Yildiz, MD, Principal investigator, Cantonal Hospital Saint Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250678
- Sponsor's protocol ID
- CogNtz
- Status last verified
- Nov 2010
- First submitted
- 30 Nov 2010
- Last updated
- 1 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Yildiz M, Tettenborn B, Radue EW, Bendfeldt K, Borgwardt S. Association of cognitive impairment and lesion volumes in multiple sclerosis--a MRI study. Clin Neurol Neurosurg. 2014 Dec;127:54-8. doi: 10.1016/j.clineuro.2014.09.019. Epub 2014 Oct 14.
PubMed 25459243
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Changes in Patients With Remitting Relapsing Multiple Sclerosis Treated With Natalizumab
- ClinicalTrials.gov ID
- NCT01250678
- Acronym / sponsor ID
- CogNtz
- Conditions
- Multiple Sclerosis, Cognitive Impairment
- Keywords
- multiple sclerosis, cognitive impairment, natalizumab, SDMT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- Jan 2011
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 1 Dec 2010 (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.
Cognitive impairment is seen in about half of patients with relapsing remitting MS. Our knowledge about long term development of cognitive performance under natalizumab therapy is limited. We want to demonstrate with this study that patients treated with ntz improve in neurocognitive tests over the long term.
Detailed description
Impaired cognitive function may represent damage to brain regions that are not involved in physical functions, hence may not be detected during routine neurological assessment. Despite the high prevalence of cognitive impairment in MS, cognitive function is not assessed routinely in clinical practice. The perception that cognitive assessments are costly, time-consuming, complicated, and difficult to administer and interpret has contributed, at least in part, to the failure to incorporate cognitive testing into standard clinical evaluation of patients with MS.
Cognitive impairment may also reduce the ability of patients to comprehend and adhere to treatment concepts (Bobholz 2003). Early detection of cognitive impairment is important to initiate therapeutic intervention, even though the optimal treatment of cognitive decline in MS is at the moment controversial.
Preliminary studies suggest an essential role of disease modifying therapies (DMT) in inhibition of cognitive deterioration in patients with MS (Barak 2002, Flechter 2007). Data about long term cognitive performance of multiple sclerosis patients treated with natalizumab is limited. One study demonstrated in MS patients treated with natalizumab an improvement in SDMT (Symbol Digit Modalities Test) of 16.4% over a period of 2 years (Piehl 2010). SDMT is a screening tool for cognitive impairment in MS patients, mainly measuring working memory and speed processing. As SDMT only covers a part of the neurocognitive impairments seen in MS patients, there is a need for further studies to gain a more complete picture.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neurocognitive impaired | – | –MS patients treated with natalizumab who at the beginning of the study suffer from cognitive impairment |
| neurocognitive non-impaired | – | –MS patients treated with natalizumab who at the beginning of the study do not suffer from cognitive impairment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- MS-patients will be recruited in the outpatient clinic of the neurology department of the cantonal hospital of Saint Gallen, responsible for treatment of MS patients of Northeast Switzerland.
Key inclusion criteria (4 listed)
- Patients between 18 and 55 years at presentation
- Diagnosis of relapsing-remitting MS according to revised McDonald criteria 2005
- Patients treated with ntz
- EDSS under 5.5
Key exclusion criteria (11 listed)
- Brain pathology other than MS
- Known history of head trauma
- Pure spinal manifestation of demyelization
- Neuromyelitis optica
- Primary and secondary progressive MS
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
The Symbol Digit Modalities Test (SDMT)
Time frame: 3 years
SDMT is an easily administered brief screening tool for cognitive dysfunction in MS. Patients view a key presenting nine numbers paired with symbols. Below the key is an array of symbols paired with empty spaces, the patient's task being to voice the matching number for each symbol as rapidly as possible.
3 secondary outcomes
Multiple Sclerosis Inventory Cognition (MUSIC)
Time frame: 3 years
TAP subtest Alertness
Time frame: 3 years
Composite neurocognitive index
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2010.
- Derived from this study: PubMed 25459243Yildiz M, Tettenborn B, Radue EW, Bendfeldt K, Borgwardt S. Association of cognitive impairment and lesion volumes in multiple sclerosis--a MRI study. Clin Neurol Neurosurg. 2014 Dec;127:54-8. doi: 10.1016/j.clineuro.2014.09.019. Epub 2014 Oct 14.
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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.
Murat Yildiz, MD principal investigator
Cantonal Hospital Saint Gallen
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 Multiple Sclerosis and Cognitive Impairment, run by Cantonal Hospital of St. Gallen at 1 site in 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 11 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 1 Dec 2010. 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 Switzerland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Symbol Digit Modalities Test (SDMT) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01250678, which also lists 1 linked publication.
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 1 Dec 2010; AzTrials last refreshed its copy on 5 Nov 2026.