Mild Cognitive Impairment Clinical Trial
Official title:
Imaging the Neural Network Connectivity on Patients With Mild Cognitive Impairment
NCT number | NCT01927653 |
Other study ID # | 98-3628B |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2011 |
Est. completion date | February 2017 |
Verified date | July 2018 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
1. 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.
2. 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
Status | Completed |
Enrollment | 108 |
Est. completion date | February 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Years to 70 Years |
Eligibility |
Inclusion Criteria: 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 Exclusion Criteria: The following exclusion criteria apply to all groups. 1. Cardiac pacemaker implantation. 2. Implantation of intracranial metal device. 3. Other major systemic disease, such as renal failure, heart failure, stroke, AMI/unstable angina, poor controlled diabetes mellitus, poor controlled hypertension. 4. Alcohol or drug abuse 5. Meet the criteria for dementia ( DSM-IV ) 6. History of neurological disorder 7. Current psychiatrical illness 8. Head trauma with loss of consciousness greater than 10 minutes 9. Severe sensory deficit 10. Taking medication that affect cognition 11. Vascular lesion on MRI with Longstreth grade >=4 12. Structural abnormalities that could produce dementia, such as cortical infarction, tumor, or subdural hematoma 13. 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: 1. 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. 2. Probable AD defined by NINCDS/ADRDA criteria. 3. Caregiver/informant to accompany patient to all scheduled visits. 4. HAM-D rating scale score of 12 on the 17-item scale(19) or Cornell Scale for Depression in Dementia (CSDD) score<8(20). |
Country | Name | City | State |
---|---|---|---|
Taiwan | ChangGung Memorial Hospital, Linkou | Tao Yuan |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
end of the first year | |
Secondary | 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. | end of the third year |
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