Mild Cognitive ImpairmentNCT01927653
Imaging the Neural Network Connectivity on Patients With Mild Cognitive Impairment
An observational study of Mild Cognitive Impairment, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The hypothesis tested if the diffusion properties in the base line, such as mean diffusivity or kurtosis, can differentiate two subtypes of MCI and predict the clinical outcome in Patients. The hypothesis further supports the correlation of the measured diffusion properties and the disease severity. Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- How many people
- 108 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2011to Feb 2017
- 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 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient will be recruited from the movement disorder clinics in ChangGung memorial hospital LinKou. The healthy control will be recruited from the local community in northem Taiwan.
Who may be able to join
- The patients with amnestic MCI
- The patients with single domain amnestic MCI have a Clinical Dementia Rating score of 0.5 with isolated memory impairment without deficits in other cognitive domains. A cutoff scores below 1.5 Standard Deviation (SD) (or 7 percentile) of one of the tests in domains of cognitions employed psychometric tests; They should meet the following criteria:
- memory complaint
- normal general cognition
- normal activities of daily living
- not demented
Show all 17Show fewer
- The patients with dysexecutive MCI
- The patients of dMCI have relatively focal dysfunction in executive domain with the tests of memory, language and visuospatial skills within normal limits. The patients with single domain dysexecutive MCI should meet the following criteria:
- relatively focal executive dysfunction
- Within reference range on tests of memory, language and visuospatial skills
- normal general cognition
- normal activities of daily living
- not demented
- The healthy volunteers
- The healthy volunteers should be normal neuropsychological assessments as well as CDR=0 without significant neuropsychiatric disorder, right-handed, gender balanced and meet the following criteria:
- Age and gender matched healthy subjects without significant neuropsychiatric disorder
- Able to understand and provide signed informed consent
Who cannot join
- The following exclusion criteria apply to all groups.
- Cardiac pacemaker implantation.
- Implantation of intracranial metal device.
- Other major systemic disease, such as renal failure, heart failure, stroke, AMI/unstable angina, poor controlled diabetes mellitus, poor controlled hypertension.
- Alcohol or drug abuse
- Meet the criteria for dementia ( DSM-IV )
Show all 20Show fewer
- History of neurological disorder
- Current psychiatrical illness
- Head trauma with loss of consciousness greater than 10 minutes
- Severe sensory deficit
- Taking medication that affect cognition
- Vascular lesion on MRI with Longstreth grade >=4
- Structural abnormalities that could produce dementia, such as cortical infarction, tumor, or subdural hematoma
- Treatments or concurrent illnesses other than Alzheimer disease that interfered with cognitive function.
- Conversion Criteria
- Patient with AD is not an enrolling group. The criteria as the MCI patients converted to is defined by NINCDS-ADRDA Criteria and CDR=0.5, 1 or 2. The diagnosis is based on the following:
- CDR = 0.5, 1.0 or 2.0. For those of CDR 0.5, the diagnosis of MCI or AD depends on the judgment of the investigators on the level of clinical, ADL and neuropsychological impairment.
- Probable AD defined by NINCDS/ADRDA criteria.
- Caregiver/informant to accompany patient to all scheduled visits.
- HAM-D rating scale score of 12 on the 17-item scale(19) or Cornell Scale for Depression in Dementia (CSDD) score<8(20).
Trial locations and contacts
1 site in 1 country.
About this study
The hypothesis tested if the diffusion properties in the base line, such as mean diffusivity or kurtosis, can differentiate two subtypes of MCI and predict the clinical outcome in Patients. The hypothesis further supports the correlation of the measured diffusion properties and the disease severity. We therefore proposed to investigate the potential value of diffusion properties as a possible tool to monitor the disease progression. The disease related changes in neural connectivity will be investigated.
- The diffusion MRI could provide an improved diagnosis of Alzheimer's Disease and Mild cognitive Impairment. Explanation: The deposition of the macromolecules such as beta amyloid in the brain and the associated neuron death of the patient could lead to observable changes in tissue microenvironment. The related changes would lead to alterations in either the amplitude or distribution of water diffusion. In turn it could be detected in diffusion tensor and kurtosis.
- aMCI is a preclinical state of AD and dMCI is from a different etiology, which can be differentially diagnosis by MRI. Diffusion Imaging could help to predict the clinical outcome Explanation
Read the detailed description
Mild Cognitive Impairment (MCI) referred to a decline of cognition in elder adults that are not of sufficient magnitude to meet the criteria for dementia. It is usually regarded as a transition state between patients of Alzheimer's Disease (AD) and the age matched healthy adults. It is a heterogeneous syndrome which can be divided into two subtypes: amnestic and dysexecutive. This 3 year proposal continues from a NSc funded project, in which we reported that the amnestic MCI could involve global white matter changes and therefore could be a preclinical status to AD. In contrast, no compromise in white matter status was found in patients of dysexecutive MCI. Therefore we proposed to further investigate the phenomena in this project.
The subjects will be divided into 3 groups: 30 patients with amnestic MCI, 30 with dysexecutive MCI and 30 healthy age-matched normal controls. Comprehensive neuropsychological examinations will be performed after detailed clinical history and physical screening, including Mini-Mental Status Examination, Clinical Dementia Rating and the Cognitive Abilities Screening Instrument. Successful candidate will be examined by 3T MRI, including diffusion imaging and high resolution T1 weighted anatomical images.
The current project proposed to examine the sensitivity and specificity of diffusion Magnetic Resonance Imaging, in the diagnosis of MCI and differential diagnosis of two subtypes. Both the conventional tensor derived indices and diffusion kurtosis will be compared. This is due to the fact that in a recently publication in Radiology, we reported an improved diagnostic performance on neurodegenerative disease from diffusion kurtosis than diffusion tensor. Secondly we will examine the regional changes of diffusion properties and correlated with the white matter involvement in patients. High resolution track density images will be implemented and compared with the susceptibility weighted imaging in an effort to address the underlying changes in pathophysiology. In the third year, the prognostic value of diffusion MRI will be determined. The optimal cutoff value of diffusion MRI in the prediction of conversion to Alzheimer's disease will be reported. The diffusion properties in patients with early conversion (the 2nd year) and late conversion (the 3rd year) will be compared.
It is expected that changes in diffusion can be used as an image based surrogate marker during the neurodegenerative process. The new insight into the temporal evolution of the diffusion MRI might help to understand the underlying etiology and pathophysiology between the amnestic and dysexecutive MCI patients, which can contribute to an early intervention strategy and might ultimately lead to an effective treatment.
- Conditions
- Mild Cognitive Impairment
- Keywords
- Amnestic mild cognitive impairment, Dysexecutive mild cognitive impairment, Diffusion MRI
- 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 |
|---|---|---|
| The patients with amnestic MCI | The patients with single domain amnestic MCI have a Clinical Dementia Rating score of 0.5 with isolated memory impairment without deficits in other cognitive domains. A cutoff scores below 1.5 Standard Deviation (SD) (or 7 percentile) of one of the tests in domains of cognitions employed psychometric tests; They should meet the following criteria: 1. memory complaint 2. normal general cognition 3. normal activities of daily living 4. not demented | |
| The patients with dysexecutive MCI | The patients of dMCI have relatively focal dysfunction in executive domain with the tests of memory, language and visuospatial skills within normal limits. The patients with single domain dysexecutive MCI should meet the following criteria: 1. relatively focal executive dysfunction 2. Within reference range on tests of memory, language and visuospatial skills 3. normal general cognition 4. normal activities of daily living 5. not demented | |
| The healthy volunteers | The healthy volunteers should be normal neuropsychological assessments as well as CDR=0 without significant neuropsychiatric disorder, right-handed, gender balanced and meet the following criteria: 1. Age and gender matched healthy subjects without significant neuropsychiatric disorder 2. Able to understand and provide signed informed consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
differentiation of MCI using diffusion MRI
The following will be measured in order to assess the diagnostic performance of diffusion MRI
- the sensitivity and specificity determined by Receiver operatic characteristic analysis
- the correlation between the neuropsychiatry batter and the measured diffusivity To determine the diagnostic sensitivity and specificity of MCI using diffusion MRI.
With these two measurement, the outcome is to differentiate the subtypes of MCI
Measured: end of the first year
Secondary outcomes (1)
Prognosis value of diffusion MRI
The clinical deterioration will be determined by the difference in neuropsychiatry battery between the third year and the first year. The analysis will be made with and without the first year diffusion MRI. It will then be determined if the first year diffusion MRI can predict the decline in the third year. An optimal cutoff value will be calculated.
Measured: end of the third year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2013 (estimated)
- Study startJan 2011
- Primary completionDec 2016
- Study completionFeb 2017
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 Chang Gung Memorial HospitalThe 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-control
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang . Jiun-Jie, Chang Gung Memorial Hospital
- Investigators
- Jiun-Jie Wang, PhD, Principal investigator, ChangGung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927653
- Sponsor's protocol ID
- 98-3628B
- Status last verified
- Jul 2018
- First submitted
- 19 Jun 2013
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging the Neural Network Connectivity on Patients With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT01927653
- Acronym / sponsor ID
- 98-3628B
- Conditions
- Mild Cognitive Impairment
- Keywords
- Amnestic mild cognitive impairment, Dysexecutive mild cognitive impairment, Diffusion MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 22 Aug 2013 (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 hypothesis tested if the diffusion properties in the base line, such as mean diffusivity or kurtosis, can differentiate two subtypes of MCI and predict the clinical outcome in Patients. The hypothesis further supports the correlation of the measured diffusion properties and the disease severity. We therefore proposed to investigate the potential value of diffusion properties as a possible tool to monitor the disease progression. The disease related changes in neural connectivity will be investigated.
- The diffusion MRI could provide an improved diagnosis of Alzheimer's Disease and Mild cognitive Impairment. Explanation: The deposition of the macromolecules such as beta amyloid in the brain and the associated neuron death of the patient could lead to observable changes in tissue microenvironment. The related changes would lead to alterations in either the amplitude or distribution of water diffusion. In turn it could be detected in diffusion tensor and kurtosis.
- aMCI is a preclinical state of AD and dMCI is from a different etiology, which can be differentially diagnosis by MRI. Diffusion Imaging could help to predict the clinical outcome Explanation
Detailed description
Mild Cognitive Impairment (MCI) referred to a decline of cognition in elder adults that are not of sufficient magnitude to meet the criteria for dementia. It is usually regarded as a transition state between patients of Alzheimer's Disease (AD) and the age matched healthy adults. It is a heterogeneous syndrome which can be divided into two subtypes: amnestic and dysexecutive. This 3 year proposal continues from a NSc funded project, in which we reported that the amnestic MCI could involve global white matter changes and therefore could be a preclinical status to AD. In contrast, no compromise in white matter status was found in patients of dysexecutive MCI. Therefore we proposed to further investigate the phenomena in this project.
The subjects will be divided into 3 groups: 30 patients with amnestic MCI, 30 with dysexecutive MCI and 30 healthy age-matched normal controls. Comprehensive neuropsychological examinations will be performed after detailed clinical history and physical screening, including Mini-Mental Status Examination, Clinical Dementia Rating and the Cognitive Abilities Screening Instrument. Successful candidate will be examined by 3T MRI, including diffusion imaging and high resolution T1 weighted anatomical images.
The current project proposed to examine the sensitivity and specificity of diffusion Magnetic Resonance Imaging, in the diagnosis of MCI and differential diagnosis of two subtypes. Both the conventional tensor derived indices and diffusion kurtosis will be compared. This is due to the fact that in a recently publication in Radiology, we reported an improved diagnostic performance on neurodegenerative disease from diffusion kurtosis than diffusion tensor. Secondly we will examine the regional changes of diffusion properties and correlated with the white matter involvement in patients. High resolution track density images will be implemented and compared with the susceptibility weighted imaging in an effort to address the underlying changes in pathophysiology. In the third year, the prognostic value of diffusion MRI will be determined. The optimal cutoff value of diffusion MRI in the prediction of conversion to Alzheimer's disease will be reported. The diffusion properties in patients with early conversion (the 2nd year) and late conversion (the 3rd year) will be compared.
It is expected that changes in diffusion can be used as an image based surrogate marker during the neurodegenerative process. The new insight into the temporal evolution of the diffusion MRI might help to understand the underlying etiology and pathophysiology between the amnestic and dysexecutive MCI patients, which can contribute to an early intervention strategy and might ultimately lead to an effective treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The patients with amnestic MCI | – | –The patients with single domain amnestic MCI have a Clinical Dementia Rating score of 0.5 with isolated memory impairment without deficits in other cognitive domains. A cutoff scores below 1.5 Standard Deviation (SD) (or 7 percentile) of one of the tests in domains of cognitions employed psychometric tests; They should meet the following criteria: 1. memory complaint 2. normal general cognition 3. normal activities of daily living 4. not demented |
| The patients with dysexecutive MCI | – | –The patients of dMCI have relatively focal dysfunction in executive domain with the tests of memory, language and visuospatial skills within normal limits. The patients with single domain dysexecutive MCI should meet the following criteria: 1. relatively focal executive dysfunction 2. Within reference range on tests of memory, language and visuospatial skills 3. normal general cognition 4. normal activities of daily living 5. not demented |
| The healthy volunteers | – | –The healthy volunteers should be normal neuropsychological assessments as well as CDR=0 without significant neuropsychiatric disorder, right-handed, gender balanced and meet the following criteria: 1. Age and gender matched healthy subjects without significant neuropsychiatric disorder 2. Able to understand and provide signed informed consent |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient will be recruited from the movement disorder clinics in ChangGung memorial hospital LinKou. The healthy control will be recruited from the local community in northem Taiwan.
Key inclusion criteria (17 listed)
- The patients with amnestic MCI
- The patients with single domain amnestic MCI have a Clinical Dementia Rating score of 0.5 with isolated memory impairment without deficits in other cognitive domains. A cutoff scores below 1.5 Standard Deviation (SD) (or 7 percentile) of one of the tests in domains of cognitions employed psychometric tests; They should meet the following criteria:
- memory complaint
- normal general cognition
- normal activities of daily living
Key exclusion criteria (20 listed)
- The following exclusion criteria apply to all groups.
- Cardiac pacemaker implantation.
- Implantation of intracranial metal device.
- Other major systemic disease, such as renal failure, heart failure, stroke, AMI/unstable angina, poor controlled diabetes mellitus, poor controlled hypertension.
- Alcohol or drug abuse
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
differentiation of MCI using diffusion MRI
Time frame: end of the first year
The following will be measured in order to assess the diagnostic performance of diffusion MRI 1. the sensitivity and specificity determined by Receiver operatic characteristic analysis 2. the correlation between the neuropsychiatry batter and the measured diffusivity To determine the diagnostic sensitivity and specificity of MCI using diffusion MRI. With these two measurement, the outcome is to differentiate the subtypes of MCI
1 secondary outcome
Prognosis value of diffusion MRI
Time frame: end of the third year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
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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.
Jiun-Jie Wang, PhD principal investigator
ChangGung University
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 Chang Gung Memorial Hospital at 1 site in Taiwan.
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 17 inclusion and 20 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: finished, as of the sponsor's last update on 18 Jul 2018. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
differentiation of MCI using diffusion MRI (time frame: end of the first 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 18 Jul 2018.