Predicting the Conversion From Mild Cognitive Impairment... | NCT01823666

Studies
Predicting the Conversion From Mild Cognitive Impairment to Dementia

NCT01823666

Sponsor

Dongzhimen Hospital, Beijing

Status

Completed

Last Update Posted

Aug 23, 2021Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Mild Cognitive Impairment
Alzheimer Disease
Dementia, Vascular

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Aug 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Mar 30, 2013

First Submission Date that Met QC Criteria

Apr 3, 2013

First Posted Date

Apr 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2021

Last Update Posted Date

Aug 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Mild cognitive impairment (MCI) is believed to be the early stage of dementia. The investigators assume that some psychological and imaging risks may predict the conversion. In the current longitudinal study, psychological and imaging data of people with MCI will be obtained at baseline, and will be followed at 26 weeks and 52 weeks. The predictors will be found in comparison with controls.

Detailed Description

MCI increases the risk of later developing dementia. About 10-15% of the amnestic form of mild cognitive impairment will progress to Alzheimer's disease in one year. But some people with MCI never get worse. Others with MCI later have test results that return to normal for their age and education.

To develop a new drug for the prevention of dementia(dementia due to Alzheimer's disease or vascular dementia), investigators need a sensitive and specific tool for recognizing patients who will converse to dementia. The investigators want to establish an operational diagnostic criteria instead of a descriptive criteria for mild cognitive impairment.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mild cognitive impairment		People with cognitive complaint will be recruited. Who can be diagnosed as mild cognitive impairment will be enrolled according to the MCI criteria.
Control		Normal cognition.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of conversion to dementia		At baseline, 26 weeks, and 52 weeks.

Secondary Outcomes

Measure	Description	Time Frame
Mini-Mental State Examination		At baseline, 26 weeks, and 52 weeks
Immediate and delayed story recall		At baseline, 26 weeks, and 52 weeks
Clock Drawing Test(CDT)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

complaint about cognitive decline compared to previous performance
objective cognitive impairment in one or more cognitive domains for age
preservation of independence in functional abilities
Mini-Mental State Examination(MMSE) scores between 24 and 30
a Clinical Dementia Rating(CDR) score of 0.5

Exclusion Criteria:

dementia
patient with any following disease: Parkinson's disease, multiple system atrophy, normal pressure hydrocephalus, progressive supranuclear palsy, subarachnoid hemorrhage, brain neoplasms, Huntington disease, epilepsy
depression(HAMD >7) or psychosis
uncontrolled severe medical conditions(i.e., acute heart failure, renal insufficiency)
current treatment with benzodiazepines, antidepressants, antipsychotics, or other medications with significant psychotropic or central cholinergic effects
abnormal thyroid, low vitamin B12 level or low folic acid level
patient with visual and auditory disorders can't cooperate with neuropsychological assessment
patient can't cooperate with following up
informed consent is not obtained

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

People with cognitive complaint living in the community.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jinzhou Tian, Doctor	Dongzhimen Hospital, Beijing	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine		Beijing	Beijing Municipality	100700	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26172064	Derived	Ni J, Shi J, Wei M, Tian J, Jian W, Liu J, Liu T, Liu B. Screening mild cognitive impairment by delayed story recall and instrumental activities of daily living. Int J Geriatr Psychiatry. 2015 Aug;30(8):888-90. doi: 10.1002/gps.4317. No abstract available.

ID	Term
D060825	Cognitive Dysfunction
D000544	Alzheimer Disease
D015140	Dementia, Vascular
D003704	Dementia

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D001927	Brain Diseases