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Cognitive Intervention for Persons With Amnestic Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
rehabilitation & remediation approach
remediation approach
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mild Cognitive Impairment

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Criteria: Inclusion Criteria:

  • over 50 years old
  • years of education > 6
  • mild cognitive impairment diagnosed by physician
  • no dementia diagnosis
  • Barthel Index scored 100
  • Geriatric Depression Scale-Short Form scored < 8

Exclusion Criteria:

  • without concurrent major or significant psychiatric disorders
  • severe physical diseases which might affect cognitive functions
  • difficult to follow instructions due to visual or hearing impairments

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

rehabilitation & remediation approach

remediation approach

Arm Description

The intervention group will receive 12 weekly 90-minute combined cognition interventions in a group. The first half of each session will be cognitive training which focus on teaching various cognitive strategies and their applications to enhance the attention, memory, processing speed, and executive functions. The second half of the session will apply rehabilitation intervention with various compensatory strategies. Investigators will use group discussion to discuss everyday situations with memory problem and specific strategies (internal and external) related to real-life situations. Investigators will also include one individual session in the 12 group sessions.

The remediation approach will receive 12 weekly 90-minute cognitive training which focus on teaching various cognitive strategies and their applications to enhance the attention, memory, processing speed, and executive functions.

Outcomes

Primary Outcome Measures

Change from Baseline The Brief University of California San Diego (UCSD) Performance-Based Skills Assessment (Traditional Chinese Version)(UPSA-Brief ) at the 12th and 24th weeks

Secondary Outcome Measures

Change from Baseline Short-form Zarit Caregiver Burden Interview-12 (sCZBI-12) at the 12th and 24th weeks
Change from Baseline Montreal Cognitive Assessment (MoCA) Taiwan Version at the 12th and 24th weeks
Change from Baseline Word Sequence Learning Test at the 12th and 24th weeks
Change from Baseline Minimal-Mental Status Exam (MMSE) at the 12th and 24th weeks
Change from Baseline Miami Prospective Memory Test (MPMT) at the 12th and 24th weeks
Change from Baseline Color Trails Test at the 12th and 24th weeks
Change from Baseline Structure MRI at the 12th and 24th weeks
Change from Baseline PiB-PET and FDG-PET at the 12th and 24th weeks
PiB-PET: Pittsburgh Compound B-Positron Emission Tomography FDG-PET:18-Fluoro-deoxyglucose positron emission tomography
Change from Baseline amyloid Aβ40, Aβ42 and tau proteins at the 12th and 24th weeks
Change from Baseline The Disability Assessment for Dementia (DAD) at the 12th and 24th weeks
Change from Baseline Quality of Life-Alzheimer's Disease scale (QoL-AD) at the 12th and 24th weeks
Change from Baseline Goal Attainment Scaling (GAS) at the 12th and 24th weeks
Change from Baseline Everyday Memory Questionnaire at the 12th and 24th weeks

Full Information

First Posted
May 18, 2016
Last Updated
March 13, 2019
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02785315
Brief Title
Cognitive Intervention for Persons With Amnestic Mild Cognitive Impairment
Official Title
Cognitive Intervention for Persons With Amnestic Mild Cognitive Impairment: The Efficacy in Enhancement of Cognition and Complex Activities of Daily Living Function
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 16, 2014 (Actual)
Primary Completion Date
November 14, 2017 (Actual)
Study Completion Date
November 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
People with mild cognitive impairment (MCI) are at a greater risk of developing dementia. Therefore, it is important to develop effective non-pharmacological interventions to facilitate their cognitive and activities of daily living (ADL) function, which will also prevent or delay their progression to dementia and reduce associated healthcare and social costs. There are currently a variety of cognitive interventions, mainly categorized as remediation and rehabilitation approach. Research to compare their contents and effectiveness is strongly needed. The information can be used to individualize cognitive intervention based on specific cognitive profile of the patient. This study aims to determine the immediate and long-term efficacy of the remediation approach and rehabilitation approach in enhancing the cognitive and ADL function. The research questions include 1) whether the rehabilitation approach compared with the remediation approach has better effects on improving ADL function; (2) whether the remediation approach may only enhance the performance on the cognitive tests rather than on the ADL function. This study will also explore whether the attitudes of caregivers on providing ADL assistance affect effects of cognitive intervention.
Detailed Description
The study is designed by a single-blinded randomized control trial. Sixty persons with MCI, confirmed by physicians, will receive 12 weekly 90-minute cognition interventions in a group of 6-8 persons. All participants will be randomly assigned to the following groups: 1) Remediation approach: various cognitive strategies will be taught, and exercises involving the practice of these strategies to enhance the attention, memory, processing speed, and executive functions. 2) Combination of rehabilitation and remediation approaches: The first half of each session will focus on the remediation approach as described above. The second half of the session will apply rehabilitation approach. The investigators will use group discussion to discuss everyday situations with memory problem and specific strategies (internal and external) related to real-life situations. The investigators will also include one individual session in the 12 group sessions. All participants will be assessed at 3 time points: before intervention, right after intervention, and 12 weeks after the intervention. The primary outcomes are the ADL functions evaluated by subjective and objective measures, and cognitive function evaluated by tests of attention, memory and executive function. The secondary outcomes include the depression, the quality of life of the participants, and the caregivers' load. The intervention effects will be further analyzed by the caregivers' attitude regarding to the level of ADL assistance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rehabilitation & remediation approach
Arm Type
Experimental
Arm Description
The intervention group will receive 12 weekly 90-minute combined cognition interventions in a group. The first half of each session will be cognitive training which focus on teaching various cognitive strategies and their applications to enhance the attention, memory, processing speed, and executive functions. The second half of the session will apply rehabilitation intervention with various compensatory strategies. Investigators will use group discussion to discuss everyday situations with memory problem and specific strategies (internal and external) related to real-life situations. Investigators will also include one individual session in the 12 group sessions.
Arm Title
remediation approach
Arm Type
Active Comparator
Arm Description
The remediation approach will receive 12 weekly 90-minute cognitive training which focus on teaching various cognitive strategies and their applications to enhance the attention, memory, processing speed, and executive functions.
Intervention Type
Behavioral
Intervention Name(s)
rehabilitation & remediation approach
Intervention Description
The rehabilitation & remediation approach group will receive 12 weekly 90-minute combined cognition interventions in a group. The first half of each session will be cognitive training which focus on teaching various cognitive strategies to enhance the attention, memory, processing speed, and executive functions. The second half of the session will apply rehabilitation intervention by discussing everyday situations with memory problem and specific strategies related to real-life situations. Investigators will also include one individual session in the 12 group sessions.
Intervention Type
Behavioral
Intervention Name(s)
remediation approach
Intervention Description
The remediation approach will receive 12 weekly 90-minute cognitive training which focus on teaching various cognitive strategies and their applications to enhance the attention, memory, processing speed, and executive functions.
Primary Outcome Measure Information:
Title
Change from Baseline The Brief University of California San Diego (UCSD) Performance-Based Skills Assessment (Traditional Chinese Version)(UPSA-Brief ) at the 12th and 24th weeks
Time Frame
baseline, 12th and 24th weeks after intervention
Secondary Outcome Measure Information:
Title
Change from Baseline Short-form Zarit Caregiver Burden Interview-12 (sCZBI-12) at the 12th and 24th weeks
Time Frame
baseline, 12th and 24th weeks after intervention
Title
Change from Baseline Montreal Cognitive Assessment (MoCA) Taiwan Version at the 12th and 24th weeks
Time Frame
baseline, 12th and 24th weeks after intervention
Title
Change from Baseline Word Sequence Learning Test at the 12th and 24th weeks
Time Frame
baseline, 12th and 24th weeks after intervention
Title
Change from Baseline Minimal-Mental Status Exam (MMSE) at the 12th and 24th weeks
Time Frame
baseline, 12th and 24th weeks after intervention
Title
Change from Baseline Miami Prospective Memory Test (MPMT) at the 12th and 24th weeks
Time Frame
baseline, 12th and 24th weeks after intervention
Title
Change from Baseline Color Trails Test at the 12th and 24th weeks
Time Frame
baseline, 12th and 24th weeks after intervention
Title
Change from Baseline Structure MRI at the 12th and 24th weeks
Time Frame
baseline, 12th and 24th weeks after intervention
Title
Change from Baseline PiB-PET and FDG-PET at the 12th and 24th weeks
Description
PiB-PET: Pittsburgh Compound B-Positron Emission Tomography FDG-PET:18-Fluoro-deoxyglucose positron emission tomography
Time Frame
baseline, 12th and 24th weeks after intervention
Title
Change from Baseline amyloid Aβ40, Aβ42 and tau proteins at the 12th and 24th weeks
Time Frame
baseline, 12th and 24th weeks after intervention
Title
Change from Baseline The Disability Assessment for Dementia (DAD) at the 12th and 24th weeks
Time Frame
baseline, 12th and 24th weeks after intervention
Title
Change from Baseline Quality of Life-Alzheimer's Disease scale (QoL-AD) at the 12th and 24th weeks
Time Frame
baseline, 12th and 24th weeks after intervention
Title
Change from Baseline Goal Attainment Scaling (GAS) at the 12th and 24th weeks
Time Frame
baseline, 12th and 24th weeks after intervention
Title
Change from Baseline Everyday Memory Questionnaire at the 12th and 24th weeks
Time Frame
baseline, 12th and 24th weeks after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Criteria: Inclusion Criteria: over 50 years old years of education > 6 mild cognitive impairment diagnosed by physician no dementia diagnosis Barthel Index scored 100 Geriatric Depression Scale-Short Form scored < 8 Exclusion Criteria: without concurrent major or significant psychiatric disorders severe physical diseases which might affect cognitive functions difficult to follow instructions due to visual or hearing impairments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Fen Mao
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Cognitive Intervention for Persons With Amnestic Mild Cognitive Impairment

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