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Completed

NCT Number: NCT01823666

Predicting the Conversion From Mild Cognitive Impairment to Dementia

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.

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Key information

Conditions

Mild Cognitive Impairment Alzheimer Disease Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Dementia Dementia, Vascular Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies Vascular Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100700, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate of conversion to dementia

    Time frame: At baseline, 26 weeks, and 52 weeks.

Secondary outcomes

  1. Mini-Mental State Examination

    Time frame: At baseline, 26 weeks, and 52 weeks

  2. Immediate and delayed story recall

    Time frame: At baseline, 26 weeks, and 52 weeks

  3. Clock Drawing Test(CDT)

    Time frame: At baseline, 26 weeks, and 52 weeks

  4. Boston Naming Test

    Time frame: At baseline, 26 weeks, and 52 weeks

  5. Verbal Category Fluency Test(animals)

    Time frame: At baseline, 26 weeks, and 52 weeks

  6. Trail Making Test(TMT)

    Time frame: At baseline, 26 weeks, and 52 weeks

  7. Hopkins Verbal Learning Test(HVLT)

    Time frame: At baseline, 26 weeks, and 52 weeks

Sponsors and collaborators

Lead sponsor

Dongzhimen Hospital, Beijing

Other

Registry information

Official study title

Study on Risk Factors for Prediction of Conversion to Dementia in Patients With Mild Cognitive Impairment

Acronym: PCMCItoD

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 4, 2013
Registry last updated
Aug 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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