Cognitive Intervention for Persons With Amnestic Mild Cognitive Impairment

Cognitive Intervention for Persons With Amnestic Mild Cognitive Impairment: The Efficacy in Enhancement of Cognition and Complex Activities of Daily Living Function

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: rehabilitation & remediation approach; Behavioral: remediation approach

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rehabilitation & remediation approach; 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.	Behavioral: rehabilitation & remediation approach; 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.
Active Comparator: remediation approach; 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.	Behavioral: remediation approach; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	baseline, 12th and 24th weeks after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Short-form Zarit Caregiver Burden Interview-12 (sCZBI-12) at the 12th and 24th weeks		baseline, 12th and 24th weeks after intervention
Change from Baseline Montreal Cognitive Assessment (MoCA) Taiwan Version at the 12th and 24th weeks		baseline, 12th and 24th weeks after intervention
Change from Baseline Word Sequence Learning Test at the 12th and 24th weeks		baseline, 12th and 24th weeks after intervention
Change from Baseline Minimal-Mental Status Exam (MMSE) at the 12th and 24th weeks		baseline, 12th and 24th weeks after intervention
Change from Baseline Miami Prospective Memory Test (MPMT) at the 12th and 24th weeks		baseline, 12th and 24th weeks after intervention
Change from Baseline Color Trails Test at the 12th and 24th weeks		baseline, 12th and 24th weeks after intervention
Change from Baseline Structure MRI at the 12th and 24th weeks		baseline, 12th and 24th weeks after intervention
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	baseline, 12th and 24th weeks after intervention
Change from Baseline amyloid Aβ40, Aβ42 and tau proteins at the 12th and 24th weeks		baseline, 12th and 24th weeks after intervention
Change from Baseline The Disability Assessment for Dementia (DAD) at the 12th and 24th weeks		baseline, 12th and 24th weeks after intervention
Change from Baseline Quality of Life-Alzheimer's Disease scale (QoL-AD) at the 12th and 24th weeks		baseline, 12th and 24th weeks after intervention
Change from Baseline Goal Attainment Scaling (GAS) at the 12th and 24th weeks		baseline, 12th and 24th weeks after intervention
Change from Baseline Everyday Memory Questionnaire at the 12th and 24th weeks		baseline, 12th and 24th weeks after intervention

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Hui-Fen Mao, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2014
• Primary Completion (Actual): November 14, 2017
• Study Completion (Actual): November 14, 2017

Study Registration Dates

• First Submitted: May 18, 2016
• First Submitted That Met QC Criteria: May 24, 2016
• First Posted (Estimate): May 27, 2016

Study Record Updates

• Last Update Posted (Actual): March 14, 2019
• Last Update Submitted That Met QC Criteria: March 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 201402028RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO