Efficacy Study of Cognitive Intervention in Amnestic Mild Cognitive Impairment (CogMCI)

Inha University Hospital

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Other: group cognitive intervention; Other: Home-based cognitive intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01358955

CogMCI study

Details and patient eligibility

About

• 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.

Full description

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.

Enrollment: 293 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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293 participants in 3 patient groups

Group cognitive intervention

Active Comparator group

Description:

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.

Treatment:

Other: group cognitive intervention

Home-based cognitive intervention

Active Comparator group

Description:

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

Treatment:

Other: Home-based cognitive intervention

Wait list Control

No Intervention group

Description:

They will participate in cognitive intervention after ending this study.