Mild Cognitive ImpairmentNCT02353845
Construction of Diagnosis System for Early AD Based on Multi-Modality MRI Technology
An observational study of Mild Cognitive Impairment and Alzheimer's Disease, run by XuanwuH 2 at 1 site in China.
Trial summary
One purpose of this study is to construct the diagnosis system for early Alzheimer's disease(AD), which is also called amnestic mild cognitive impairment (aMCI), and then further construct the predictable classifier from aMCI to AD based on Multi-Modality MRI characteristics of aMCI patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer's Disease
- How many people
- 297 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Aug 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: aMCI is a group of patients whose memory are impaired to a greater degree than expected given the individual's age, sex, and educational background, while the individual's ability to perform the activities of daily living is preserved and the criteria for dementia are not met.
Who may be able to join
- Memory loss complaint and confirmed by an informant
- Cognitive impairment in single or multiple domains, adjusted for age and education
- Normal or near-normal performance on general cognitive function and no or minimum impairment of daily life activities
- A Clinical Dementia Rating (CDR) score is 0.5 and consistent with the boundary of neuropsychological scale
- Failure to meet the criteria for dementia
- Must be able to accept examination of MRI, sight and hearing allow to complete test
- Right handedness
Who cannot join
- Other diseases that cause cognitive impairment, such as thyroid disease, stroke and so on
- People who have severe visual and hearing impairment
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurolgy,Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
One purpose of this study is to construct the diagnosis system for early Alzheimer's disease(AD), which is also called amnestic mild cognitive impairment (aMCI), and then further construct the predictable classifier from aMCI to AD based on Multi-Modality MRI characteristics of aMCI patients.
Read the detailed description
The cognition of aMCI is between normal aging and dementia, which is thought the transitional stage of dementia. Patients with aMCI have heavy risk to convert to AD, so in this study, the investigators focus on the construction of the diagnosis system for early AD based on multi-modality MRI characteristics of aMCI patients. Every patient underwent β-Amyloid PET, fluorodeoxyglucose-PET(FDG-PET), structural MRI, diffusion tensor imaging and functional MRI. Then investigators further study the patients who convert to AD and explore their MRI and metabolism characteristics on baseline, in order to construct the predictable classifier from aMCI to AD. The investigators want to achieve the early diagnosis of AD and help clinicians interfere with the progress of this disease.
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
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 |
|---|---|---|
| aMCI | aMCI means a group of patients who do not qualify for a diagnosis of dementia but do display memory impairment beyond what is expected for their age and with regards to the educational history and with positive β-amyloid PET | |
| normal control | Not described | |
| aMCIp | progressive aMCI：aMCI subjects who will convert to AD during the follow-up period | |
| aMCIs | stable aMCI：aMCI subjects who will not convert to AD during the follow-up period |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants correctly classified by the support vector machine (SVM) classifier for the aMCI diagnosis
two-hundred aMCI subjects and 100 normal controls recruited will undergo structure,resting-state functional magnetic resonance imaging and diffusion tensor imaging. An SVM classifier for diagnosis will be trained based on these neuroimaging data.Then leave-one-out cross validation will be used to estimate the performance of the classifier including accuracy，sensitivity，specificity.The classification accuracy will be measured by the proportion of observations that are correctly classified into the aMCI or control groups.The sensitivity is defined as TP/(TP+FN), and specificity is defined as TN/(TN+FP). The TP (true positive) is the number of aMCI images correctly classified,whereas the TN (true negative) is the number of control images correctly classified. The FP (false positive) is the number of control images classified as the aMCI, whereas the FN (false negative) is the number of aMCI images classified as controls.
Measured: 3 years
number of participants correctly predicted by the SVM classifier for predicting conversion from aMCI to AD
During 2-year follow-up, the group of aMCI will be divided into progressive aMCI (aMCIp) and stable aMCI（aMCIs）.According to the baseline neuroimaging data, an SVM classifier for predicting conversion from aMCI to AD will be trained. Then leave-one-out cross validation will be used to validate the performance of the classifier including accuracy，sensitivity，specificity.The classification accuracy will be measured by the proportion of aMCI that are correctly classified into the aMCIp or aMCIs groups.The sensitivity is defined as TP/(TP+FN), and specificity is defined as TN/(TN+FP). The TP (true positive) is the number of aMCIp images correctly classified,whereas the TN (true negative) is the number of aMCIs correctly classified. The FP (false positive) is the number of aMCIs classified as aMCIp, whereas the FN (false negative) is the number of aMCIp classified as aMCIs.
Measured: 3 years
Secondary outcomes (2)
regional cerebral metabolism (CMgl) measured by FDG-PET
different glucose consumption rate in some regions between aMCI and normal controls, and also between aMCIp and aMCIs
Measured: 3 years
changed regional cerebral blood flow measured by FDG-PET
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 posted3 Feb 2015 (estimated)
- Study startNov 2013
- Primary completionOct 2015
- Study completionAug 2016
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- XuanwuH 2
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, XuanwuH 2, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353845
- Sponsor's protocol ID
- hanying2
- Status last verified
- Aug 2016
- First submitted
- 2 Oct 2014
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of Diagnosis System for Early AD Based on Multi-Modality MRI Technology
- ClinicalTrials.gov ID
- NCT02353845
- Acronym / sponsor ID
- hanying2
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- XuanwuH 2University, hospital or other
- Study start
- Nov 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 3 Feb 2015 (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.
One purpose of this study is to construct the diagnosis system for early Alzheimer's disease(AD), which is also called amnestic mild cognitive impairment (aMCI), and then further construct the predictable classifier from aMCI to AD based on Multi-Modality MRI characteristics of aMCI patients.
Detailed description
The cognition of aMCI is between normal aging and dementia, which is thought the transitional stage of dementia. Patients with aMCI have heavy risk to convert to AD, so in this study, the investigators focus on the construction of the diagnosis system for early AD based on multi-modality MRI characteristics of aMCI patients. Every patient underwent β-Amyloid PET, fluorodeoxyglucose-PET(FDG-PET), structural MRI, diffusion tensor imaging and functional MRI. Then investigators further study the patients who convert to AD and explore their MRI and metabolism characteristics on baseline, in order to construct the predictable classifier from aMCI to AD. The investigators want to achieve the early diagnosis of AD and help clinicians interfere with the progress of this disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| aMCI | – | –aMCI means a group of patients who do not qualify for a diagnosis of dementia but do display memory impairment beyond what is expected for their age and with regards to the educational history and with positive β-amyloid PET |
| normal control | – | – |
| aMCIp | – | –progressive aMCI：aMCI subjects who will convert to AD during the follow-up period |
| aMCIs | – | –stable aMCI：aMCI subjects who will not convert to AD during the follow-up period |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- aMCI is a group of patients whose memory are impaired to a greater degree than expected given the individual's age, sex, and educational background, while the individual's ability to perform the activities of daily living is preserved and the criteria for dementia are not met.
Key inclusion criteria (7 listed)
- Memory loss complaint and confirmed by an informant
- Cognitive impairment in single or multiple domains, adjusted for age and education
- Normal or near-normal performance on general cognitive function and no or minimum impairment of daily life activities
- A Clinical Dementia Rating (CDR) score is 0.5 and consistent with the boundary of neuropsychological scale
- Failure to meet the criteria for dementia
Key exclusion criteria (2 listed)
- Other diseases that cause cognitive impairment, such as thyroid disease, stroke and so on
- People who have severe visual and hearing 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
number of participants correctly classified by the support vector machine (SVM) classifier for the aMCI diagnosis
Time frame: 3 years
two-hundred aMCI subjects and 100 normal controls recruited will undergo structure,resting-state functional magnetic resonance imaging and diffusion tensor imaging. An SVM classifier for diagnosis will be trained based on these neuroimaging data.Then leave-one-out cross validation will be used to estimate the performance of the classifier including accuracy，sensitivity，specificity.The classification accuracy will be measured by the proportion of observations that are correctly classified into the aMCI or control groups.The sensitivity is defined as TP/(TP+FN), and specificity is defined as TN/(TN+FP). The TP (true positive) is the number of aMCI images correctly classified,whereas the TN (true negative) is the number of control images correctly classified. The FP (false positive) is the number of control images classified as the aMCI, whereas the FN (false negative) is the number of aMCI images classified as controls.
number of participants correctly predicted by the SVM classifier for predicting conversion from aMCI to AD
Time frame: 3 years
During 2-year follow-up, the group of aMCI will be divided into progressive aMCI (aMCIp) and stable aMCI（aMCIs）.According to the baseline neuroimaging data, an SVM classifier for predicting conversion from aMCI to AD will be trained. Then leave-one-out cross validation will be used to validate the performance of the classifier including accuracy，sensitivity，specificity.The classification accuracy will be measured by the proportion of aMCI that are correctly classified into the aMCIp or aMCIs groups.The sensitivity is defined as TP/(TP+FN), and specificity is defined as TN/(TN+FP). The TP (true positive) is the number of aMCIp images correctly classified,whereas the TN (true negative) is the number of aMCIs correctly classified. The FP (false positive) is the number of aMCIs classified as aMCIp, whereas the FN (false negative) is the number of aMCIp classified as aMCIs.
2 secondary outcomes
regional cerebral metabolism (CMgl) measured by FDG-PET
Time frame: 3 years
changed regional cerebral blood flow measured by FDG-PET
Time frame: 3 years
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 23 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Alzheimer's Disease, run by XuanwuH 2 at 1 site in China.
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 7 inclusion and 2 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 23 Aug 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 China. 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?
number of participants correctly classified by the support vector machine (SVM) classifier for the aMCI diagnosis (time frame: 3 years). The study lists 2 primary outcomes in all. 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 23 Aug 2016.