Cognitive Intervention for Persons With Amnestic Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02785315
• Other study ID #: 201402028RINC
• Status: Completed
• Phase: N/A
• Start date: December 16, 2014
• Est. completion date: November 14, 2017

Study information

• Verified date: March 2019
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 14, 2017
• Est. primary completion date: November 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change from Baseline Montreal Cognitive Assessment (MoCA) Taiwan Version at the 12th and 24th weeks		baseline, 12th and 24th weeks after intervention
Secondary	Change from Baseline Word Sequence Learning Test at the 12th and 24th weeks		baseline, 12th and 24th weeks after intervention
Secondary	Change from Baseline Minimal-Mental Status Exam (MMSE) at the 12th and 24th weeks		baseline, 12th and 24th weeks after intervention
Secondary	Change from Baseline Miami Prospective Memory Test (MPMT) at the 12th and 24th weeks		baseline, 12th and 24th weeks after intervention
Secondary	Change from Baseline Color Trails Test at the 12th and 24th weeks		baseline, 12th and 24th weeks after intervention
Secondary	Change from Baseline Structure MRI at the 12th and 24th weeks		baseline, 12th and 24th weeks after intervention
Secondary	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
Secondary	Change from Baseline amyloid Aß40, Aß42 and tau proteins at the 12th and 24th weeks		baseline, 12th and 24th weeks after intervention
Secondary	Change from Baseline The Disability Assessment for Dementia (DAD) at the 12th and 24th weeks		baseline, 12th and 24th weeks after intervention
Secondary	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
Secondary	Change from Baseline Goal Attainment Scaling (GAS) at the 12th and 24th weeks		baseline, 12th and 24th weeks after intervention
Secondary	Change from Baseline Everyday Memory Questionnaire at the 12th and 24th weeks		baseline, 12th and 24th weeks after intervention