Mild Cognitive ImpairmentMCINCT01608256
Driving Ability Among People With Mild Cognitive Impairment
An observational study of Mild Cognitive Impairment, run by Tel Aviv University at 1 site in Israel.
Trial summary
The Purpose of this study is to assess the effect of MCI on driving ability by using on road driving test. The relationship between their driving outcome and their cognitive decline will be examined. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Mild Cognitive Impairment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2012to 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- diagnosis of Mild Cognitive Impairment(given by a neurologist), valid driver's license and driving experience of at least a year.
Who cannot join
- people diagnosed with other neurological damage such as: dementia, CVA and head injury, people with sensory or motor impairment
Trial locations and contacts
1 site in 1 country.
Areej Wishahi, B.A. contact
About this study
Official title: Assessing the Effect of MCI on Driving Ability by Using on Road Driving Test. The Relationship Between Their Driving Outcome and Their Cognitive Decline Will be Examined
The Purpose of this study is to assess the effect of MCI on driving ability by using on road driving test. The relationship between their driving outcome and their cognitive decline will be examined.
Read the detailed description
Each subject will be evaluated by test battery which is accepted to driving assessment and include: The Montreal Cognitive Assessment, Clock Drawing Task, Color Trail Test, Motor Free Visual Perception, Visual Spatial Search Task , Awareness Questionnaire and on road driving test.
The difference between outcome measures of the on road test between the patient group and the control group will be tested. The correlation between outcome measures of the on road test and the cognitive tests will be examined.
- Conditions
- Mild Cognitive Impairment
- Keywords
- mild cognitive impairment, Automobile Driving, cognitive aspects
- Medical subject headings
- 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 |
|---|---|---|
| mild cognitive impairment | men and women, aged 50 to 70. The inclusion criteria are:diagnosis of MCI (given by a neurologist), valid driver's license and driving experience of at least a year. the exclusion criteria are: people diagnosed with other neurological damage such as: dementia, CVA and head injury, people with sensory or motor impairment. | |
| Healthy people | Men and women, ages 50-70. the inclusion criteria are: healthy people with out neurological disease or psychiatric illness, have valid driver's license and driving experience of at least a year. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2013 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Areej Wishahi, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608256
- Sponsor's protocol ID
- ק0012012
- Acronym
- MCI
- Status last verified
- May 2012
- First submitted
- 25 May 2012
- Last updated
- 31 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of MCI on Driving Ability by Using on Road Driving Test. The Relationship Between Their Driving Outcome and Their Cognitive Decline Will be Examined
- ClinicalTrials.gov ID
- NCT01608256
- Acronym / sponsor ID
- MCI / ק0012012
- Conditions
- Mild Cognitive Impairment
- Keywords
- mild cognitive impairment, Automobile Driving, cognitive aspects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 31 May 2012 (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.
The Purpose of this study is to assess the effect of MCI on driving ability by using on road driving test. The relationship between their driving outcome and their cognitive decline will be examined.
Detailed description
Each subject will be evaluated by test battery which is accepted to driving assessment and include: The Montreal Cognitive Assessment, Clock Drawing Task, Color Trail Test, Motor Free Visual Perception, Visual Spatial Search Task , Awareness Questionnaire and on road driving test.
The difference between outcome measures of the on road test between the patient group and the control group will be tested. The correlation between outcome measures of the on road test and the cognitive tests will be examined.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mild cognitive impairment | – | –men and women, aged 50 to 70. The inclusion criteria are:diagnosis of MCI (given by a neurologist), valid driver's license and driving experience of at least a year. the exclusion criteria are: people diagnosed with other neurological damage such as: dementia, CVA and head injury, people with sensory or motor impairment. |
| Healthy people | – | –Men and women, ages 50-70. the inclusion criteria are: healthy people with out neurological disease or psychiatric illness, have valid driver's license and driving experience of at least a year. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- diagnosis of Mild Cognitive Impairment(given by a neurologist), valid driver's license and driving experience of at least a year.
Key exclusion criteria (1 listed)
- people diagnosed with other neurological damage such as: dementia, CVA and head injury, people with sensory or motor impairment
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2012.
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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.
Areej Wishahi, B.A. contact
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 Mild Cognitive Impairment, run by Tel Aviv University at 1 site in Israel.
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 31 May 2012. 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 Israel. 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 Areej Wishahi, B.A. (areej-joda@yahoo.com), or a site near the patient. 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 31 May 2012.