Mild Cognitive ImpairmentMoCANCT01496222
The Montreal Cognitive Assessment as a Screening Tool for Preoperative Mild Cognitive Impairment in Geriatric Patients
An observational study of Mild Cognitive Impairment, run by Mahidol University at 1 site in Thailand.
Trial summary
This is a prospective, double-blinded, control trial. The Montreal Cognitive Assessment is used to screen preoperative mild cognitive impairment in 582 consecutive geriatric patients, scheduled for general, vascular or urological surgery under general and/or regional anesthesia. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- How many people
- 582 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2012to Apr 2016
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study enrolls 582 consecutive geriatric patients,322 general and vascular patients (male 190, female 132) and 260 urological patients (male 220, female 40) who undergoing general and/or regional anesthesia.
Who may be able to join
- male or female aged 65 yr, ASA I-III scheduled for elective general, vascular or urological surgery under general and/or regional anesthesia.
Who cannot join
- unable to communicate in reading and writing
- psychosomatic patients
- insulin-dependant diabetes
- renal insufficiency (creatinine >1.5 mg/dL), renal dialysis
- uncontrolled congestive heart failure (American Heart Association Classification III or IV congestive heart failure), unstable angina, untreated cardiac arrhythmia
- active gastrointestinal bleeding.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700
About this study
Official title: The Montreal Cognitive Assessment as a Screening Tool for Preoperative Mild Cognitive
This is a prospective, double-blinded, control trial. The Montreal Cognitive Assessment is used to screen preoperative mild cognitive impairment in 582 consecutive geriatric patients, scheduled for general, vascular or urological surgery under general and/or regional anesthesia.
Read the detailed description
At the preoperative visit, the co-researcher invites 322 general and vascular patients (male 190, female 132) and 260 urological patients (male 220, female 40) who meet the inclusion criteria to join the study. The process of the project is explained to the interested patients in details before an informed consent is obtained.
All participants are interviewed by using the Montreal Cognitive Assessment test. The history of drug used preoperatively (medication reconciliation) has also been recorded.
- Conditions
- Mild Cognitive Impairment
- Keywords
- mild cognitive impairment, Montreal Cognitive Assessment test
- Medical subject headings
- Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of mild cognitive impairment in preoperative geriatric patients
Measured: 1 Year
Secondary outcomes (1)
Relationship between mild cognitive impairment and drug used preoperatively in geriatric patients
Pearson correlation coefficient will be used to evaluate the relationship between mild cognitive impairment and drug used preoperatively in geriatric patients.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionOct 2015
- Study completionApr 2016 (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.
- More trials run by Mahidol UniversityThe 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
- Prospective
- Enrolment
- 582 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phongthara Vichitvejpaisal", Mahidol University
- Investigators
- Phongthara Vichitvejpaisal, M.D., Ph.D., Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496222
- Sponsor's protocol ID
- 460/2554(EC2)
- Acronym
- MoCA
- Status last verified
- Mar 2016
- First submitted
- 15 Dec 2011
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Montreal Cognitive Assessment as a Screening Tool for Preoperative Mild Cognitive
- ClinicalTrials.gov ID
- NCT01496222
- Acronym / sponsor ID
- MoCA / 460/2554(EC2)
- Conditions
- Mild Cognitive Impairment
- Keywords
- mild cognitive impairment, Montreal Cognitive Assessment test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 582 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Apr 2016 (estimated)
- First posted
- 21 Dec 2011 (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.
This is a prospective, double-blinded, control trial. The Montreal Cognitive Assessment is used to screen preoperative mild cognitive impairment in 582 consecutive geriatric patients, scheduled for general, vascular or urological surgery under general and/or regional anesthesia.
Detailed description
At the preoperative visit, the co-researcher invites 322 general and vascular patients (male 190, female 132) and 260 urological patients (male 220, female 40) who meet the inclusion criteria to join the study. The process of the project is explained to the interested patients in details before an informed consent is obtained.
All participants are interviewed by using the Montreal Cognitive Assessment test. The history of drug used preoperatively (medication reconciliation) has also been recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study enrolls 582 consecutive geriatric patients,322 general and vascular patients (male 190, female 132) and 260 urological patients (male 220, female 40) who undergoing general and/or regional anesthesia.
Key inclusion criteria (1 listed)
- male or female aged 65 yr, ASA I-III scheduled for elective general, vascular or urological surgery under general and/or regional anesthesia.
Key exclusion criteria (6 listed)
- unable to communicate in reading and writing
- psychosomatic patients
- insulin-dependant diabetes
- renal insufficiency (creatinine >1.5 mg/dL), renal dialysis
- uncontrolled congestive heart failure (American Heart Association Classification III or IV congestive heart failure), unstable angina, untreated cardiac arrhythmia
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
Incidence of mild cognitive impairment in preoperative geriatric patients
Time frame: 1 Year
1 secondary outcome
Relationship between mild cognitive impairment and drug used preoperatively in geriatric patients
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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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.
Phongthara Vichitvejpaisal, M.D., Ph.D. principal investigator
Siriraj Hospital
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 Mahidol University at 1 site in Thailand.
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 6 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 16 Mar 2016. 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 Thailand. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of mild cognitive impairment in preoperative geriatric patients (time frame: 1 Year). 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 16 Mar 2016.