Predicting the Conversion From Mild Cognitive Impairment to Dementia

Completed

• Conditions: Alzheimer Disease; Dementia, Vascular; Mild Cognitive Impairment

• Registration Number: NCT01823666
• Lead Sponsor: Dongzhimen Hospital, Beijing

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-03-30
• Study First Submitted QC: 2013-04-03
• Study First Posted: 2013-04-04
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-18
• Last Update Posted: 2021-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of conversion to dementia	At baseline, 26 weeks, and 52 weeks.

Secondary Outcome Measures

Name	Time	Method
Mini-Mental State Examination	At baseline, 26 weeks, and 52 weeks
Trail Making Test(TMT)	At baseline, 26 weeks, and 52 weeks
Immediate and delayed story recall	At baseline, 26 weeks, and 52 weeks
Clock Drawing Test(CDT)	At baseline, 26 weeks, and 52 weeks
Boston Naming Test	At baseline, 26 weeks, and 52 weeks
Verbal Category Fluency Test(animals)	At baseline, 26 weeks, and 52 weeks
Hopkins Verbal Learning Test(HVLT)	At baseline, 26 weeks, and 52 weeks

Trial Locations

Locations (1)

Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine; 🇨🇳 Beijing, Beijing, China