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Completed

NCT Number: NCT01358955

Efficacy Study of Cognitive Intervention in Amnestic Mild Cognitive Impairment

* There will be a significant difference in cognitive function between cognitive intervention group (group therapy) and a wait list control group. * There will be a significant difference in cognitive function between a home-based cognitive intervention group and a wait list control group.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea University Medical College, Ansan, South Korea

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About this study

The change of Modified ADAS-cog score from the baseline to post-intervention will be compared between the cognitive intervention group and wait list control group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 50 to 85 years of age
  • memory complaint corroborated by a participant and an informant
  • delayed recall score on the Seoul Verbal Learning Test (SVLT) below 1.0 standard deviations from the mean of the age and education-normative values among the Korean population
  • Global CDR score is 0.5, Memory CDR score is 0.5 or 1.
  • above 1.5 standard deviations from the mean of normative data of the respective age- and education-matched population on the Korean Mini-Mental State Examination
  • normal functional activities
  • not diagnosed with dementia
  • Modified Hachinski Ischemic Score (HIS): 0-4
  • brain magnetic resonance imaging or CT showing no clinical evidence of other diseases (i.e., normal pressure hydrocephalus, brain tumor, cerebrovascular disease) capable of producing cognitive impairment.
  • Subjects are also required to have a reliable caregiver who meet the patient at least once a week and is sufficiently familiar with the patient to provide the investigator with accurate information.
  • He/She can read and write
  • written informed consent

Exclusion criteria

  • any patient who were involved in other clinical trials or treated with experimental drug within 4 weeks
  • any patients with any severe or unstable medical disease that may prevent the patient from completing all study requirements (i.e., unstable or severe asthma or cardiovascular disease, active gastric ulcer, severe hepatic or renal disease)
  • any patients with clinically significant laboratory abnormalities such as an abnormal thyroid function test, abnormal low level of vitamin B12 or folate, or positive venereal disease research laboratory test
  • any patients with any primary neurodegenerative disorder or psychiatric disorder other than AD (i.e., Parkinson's disease, schizophrenia, or major depressive disorder)
  • any patients with any history of drug or alcohol addiction during the past 10 years
  • any hearing or visual impairment that can disturb the efficient evaluation of the patient

Treatment and study plan

group cognitive intervention

Other

The cognitive training will be administered twice a week for 12 weeks, located in hospital-based outpatient memory clinics. Each session will last approximately 90 minutes. The cognitive training programs will be offered in group sessions consisted of 5 participants.

Home-based cognitive intervention

Other

The participants will do their paper and pencil homework for 30 minutes every business days for 12 weeks.

Primary outcomes

  1. Modified Alzheimer's Disease Assessment Scale-Cognitive subscale(ADAS-cog)

    Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up

Secondary outcomes

  1. story recall test

    Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up

  2. Digit span forward and backward

    Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up

  3. Word fluency test

    Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up

  4. color-word stroop test

    Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up

  5. Digit symbol test

    Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up

  6. prospective memory test

    Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up

  7. Mini-Mental State Examination

    Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up

  8. CDR-SB

    Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up

  9. K-AD8

    Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up

  10. PRMQ

    Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up

  11. MMQ-Strategy

    Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up

  12. QOL-AD

    Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up

  13. Geriatric Depression Scale-short form

    Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up

  14. Bayer ADL

    Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up

  15. CGA-NPI

    Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up

  16. Subjective cognitive assessment

    Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up

Sponsors and collaborators

Lead sponsor

Inha University Hospital

Other

Collaborators

  • Eisai Inc.

Registry information

Official study title

A Multicenter, Randomized Trial to Assess Efficacy of Home-based and Group Cognitive Intervention Programs in Amnestic Mild Cognitive Impairment

Acronym: CogMCI

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 24, 2011
Registry last updated
Aug 28, 2013

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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