Mild Cognitive ImpairmentNCT02225964
Multi-modality MRI Study on Differences in Conversion of aMCI Patients With APOEε4 to AD
An observational study of Mild Cognitive Impairment, run by XuanwuH 2 at 1 site in China.
Trial summary
This study is to find out the imaging marker and the changing laws of the marker during the course of the disease. The final purpose is to provide scientific evidence for new prevention, diagnosis and treatment of Alzheimer's disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mild Cognitive Impairment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Dec 2018
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: aMCI patients with APOEε4
Who may be able to join
- Complaint about memory loss 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
- Failure to meet the criteria for dementia
- Carrying susceptible gene APOEε4
- Must be able to accept examination of MRI, sight and hearing allow to complete test
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
This study is to find out the imaging marker and the changing laws of the marker during the course of the disease. The final purpose is to provide scientific evidence for new prevention, diagnosis and treatment of Alzheimer's disease.
Read the detailed description
It is an urgent problem in the field of cognitive neuroscience to tell the conversion progression of amnestic mild cognitive impairment(aMCI) patients with Apolipoproteinε4(APOEε4) to Alzheimer's Disease(AD). Based on our preliminary work, we will study the special group of aMCI patients with APOEε4 with multi-modality magnetic resonance imaging (resting-state functional MRI, structural MRI and diffusion tensor imaging) longitudinally. Besides, we will also detect the APOE genotype of each sample and enlarge the sample size. According to situation of the conversion or non-conversion and differences in the conversion progression, we will analyze the data between the inter-groups and intra-groups, compare the imaging data of baseline and follow-up, find the prediction imaging marker of AD and optimize the reliability and validity.
- Conditions
- Mild Cognitive Impairment
- Keywords
- APOEε4
- 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 |
|---|---|---|
| aMCIp,aMCIs | progressive aMCI,stable aMCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
the conversion of aMCI patients with APOEε4 to AD
According to situation of the conversion or non-conversion and differences in the conversion progression, we will analyze the data between the inter-groups and intra-groups, compare the imaging data of baseline and follow-up, find the prediction imaging marker of AD and optimize the reliability and validity.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- XuanwuH 2
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing
- Responsible party
- Sponsor-investigator, XuanwuH 2, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225964
- Sponsor's protocol ID
- XuanwuH 2
- Status last verified
- Jun 2020
- First submitted
- 24 Aug 2014
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li Z, Yan S, Zhao K, Wang D, Yao H, Zhou B, Zhang Z, Wang P, Liao Z, Chen Y, Zhang X, Han Y, Lu J, Liu Y. A neuroimaging biomarker for disease staging in clinically diagnosed Alzheimer's disease. BMC Med. 2026 Feb 5;24(1):145. doi: 10.1186/s12916-026-04674-6.
PubMed 41639807Lin H, Li M, Zhan Y, Lin L, Yang K, Hu S, Han Y. Disrupted white matter functional connectivity in aMCI APOEepsilon4 carriers: a resting-state study. Brain Imaging Behav. 2021 Aug;15(4):1739-1747. doi: 10.1007/s11682-020-00367-7.
PubMed 32715396Yang L, Yan Y, Wang Y, Hu X, Lu J, Chan P, Yan T, Han Y. Gradual Disturbances of the Amplitude of Low-Frequency Fluctuations (ALFF) and Fractional ALFF in Alzheimer Spectrum. Front Neurosci. 2018 Dec 20;12:975. doi: 10.3389/fnins.2018.00975. eCollection 2018.
PubMed 30618593Chen GQ, Sheng C, Li YX, Yu Y, Wang XN, Sun Y, Li HY, Li XY, Xie YY, Han Y. Neuroimaging basis in the conversion of aMCI patients with APOE-epsilon4 to AD: study protocol of a prospective diagnostic trial. BMC Neurol. 2016 May 12;16:64. doi: 10.1186/s12883-016-0587-2.
PubMed 27176479
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-modality MRI Study on Differences in Conversion of aMCI Patients With APOEε4 to AD
- ClinicalTrials.gov ID
- NCT02225964
- Acronym / sponsor ID
- XuanwuH 2
- Conditions
- Mild Cognitive Impairment
- Keywords
- APOEε4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- XuanwuH 2University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing
- Study start
- Jan 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 26 Aug 2014 (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 study is to find out the imaging marker and the changing laws of the marker during the course of the disease. The final purpose is to provide scientific evidence for new prevention, diagnosis and treatment of Alzheimer's disease.
Detailed description
It is an urgent problem in the field of cognitive neuroscience to tell the conversion progression of amnestic mild cognitive impairment(aMCI) patients with Apolipoproteinε4(APOEε4) to Alzheimer's Disease(AD). Based on our preliminary work, we will study the special group of aMCI patients with APOEε4 with multi-modality magnetic resonance imaging (resting-state functional MRI, structural MRI and diffusion tensor imaging) longitudinally. Besides, we will also detect the APOE genotype of each sample and enlarge the sample size. According to situation of the conversion or non-conversion and differences in the conversion progression, we will analyze the data between the inter-groups and intra-groups, compare the imaging data of baseline and follow-up, find the prediction imaging marker of AD and optimize the reliability and validity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aMCIp,aMCIs | – | –progressive aMCI,stable aMCI |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- aMCI patients with APOEε4
Key inclusion criteria (7 listed)
- Complaint about memory loss 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
- 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
the conversion of aMCI patients with APOEε4 to AD
Time frame: one year
According to situation of the conversion or non-conversion and differences in the conversion progression, we will analyze the data between the inter-groups and intra-groups, compare the imaging data of baseline and follow-up, find the prediction imaging marker of AD and optimize the reliability and validity.
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 2 Jul 2020.
- Derived from this study: PubMed 41639807Li Z, Yan S, Zhao K, Wang D, Yao H, Zhou B, Zhang Z, Wang P, Liao Z, Chen Y, Zhang X, Han Y, Lu J, Liu Y. A neuroimaging biomarker for disease staging in clinically diagnosed Alzheimer's disease. BMC Med. 2026 Feb 5;24(1):145. doi: 10.1186/s12916-026-04674-6.
- Derived from this study: PubMed 32715396Lin H, Li M, Zhan Y, Lin L, Yang K, Hu S, Han Y. Disrupted white matter functional connectivity in aMCI APOEepsilon4 carriers: a resting-state study. Brain Imaging Behav. 2021 Aug;15(4):1739-1747. doi: 10.1007/s11682-020-00367-7.
- Derived from this study: PubMed 30618593Yang L, Yan Y, Wang Y, Hu X, Lu J, Chan P, Yan T, Han Y. Gradual Disturbances of the Amplitude of Low-Frequency Fluctuations (ALFF) and Fractional ALFF in Alzheimer Spectrum. Front Neurosci. 2018 Dec 20;12:975. doi: 10.3389/fnins.2018.00975. eCollection 2018.
- Derived from this study: PubMed 27176479Chen GQ, Sheng C, Li YX, Yu Y, Wang XN, Sun Y, Li HY, Li XY, Xie YY, Han Y. Neuroimaging basis in the conversion of aMCI patients with APOE-epsilon4 to AD: study protocol of a prospective diagnostic trial. BMC Neurol. 2016 May 12;16:64. doi: 10.1186/s12883-016-0587-2.
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EFFECTS OF AN OUTDOOR MAT PILATES PROGRAM ON NEUROPHYSIOLOGICAL INDICATORS OF ELDERLY INDIVIDUALS WITH MILD COGNITIVE IMPAIRMENT
Cognition Disorders
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, 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 2 Jul 2020. 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?
the conversion of aMCI patients with APOEε4 to AD (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02225964, which also lists 4 linked publications.
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 2 Jul 2020.