Skip to main content
OpenTrials
Completed

NCT Number: NCT02785315

Cognitive Intervention for Persons With Amnestic Mild Cognitive Impairment

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

rehabilitation & remediation approach

Behavioral

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

Behavioral

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 outcomes

  1. 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 outcomes

  1. 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

  2. Change from Baseline Montreal Cognitive Assessment (MoCA) Taiwan Version at the 12th and 24th weeks

    Time frame: baseline, 12th and 24th weeks after intervention

  3. Change from Baseline Word Sequence Learning Test at the 12th and 24th weeks

    Time frame: baseline, 12th and 24th weeks after intervention

  4. Change from Baseline Minimal-Mental Status Exam (MMSE) at the 12th and 24th weeks

    Time frame: baseline, 12th and 24th weeks after intervention

  5. Change from Baseline Miami Prospective Memory Test (MPMT) at the 12th and 24th weeks

    Time frame: baseline, 12th and 24th weeks after intervention

  6. Change from Baseline Color Trails Test at the 12th and 24th weeks

    Time frame: baseline, 12th and 24th weeks after intervention

  7. Change from Baseline Structure MRI at the 12th and 24th weeks

    Time frame: baseline, 12th and 24th weeks after intervention

  8. Change from Baseline PiB-PET and FDG-PET at the 12th and 24th weeks

    Time frame: baseline, 12th and 24th weeks after intervention

    PiB-PET: Pittsburgh Compound B-Positron Emission Tomography FDG-PET:18-Fluoro-deoxyglucose positron emission tomography

  9. Change from Baseline amyloid Aβ40, Aβ42 and tau proteins at the 12th and 24th weeks

    Time frame: baseline, 12th and 24th weeks after intervention

  10. Change from Baseline The Disability Assessment for Dementia (DAD) at the 12th and 24th weeks

    Time frame: baseline, 12th and 24th weeks after intervention

  11. 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

  12. Change from Baseline Goal Attainment Scaling (GAS) at the 12th and 24th weeks

    Time frame: baseline, 12th and 24th weeks after intervention

  13. Change from Baseline Everyday Memory Questionnaire at the 12th and 24th weeks

    Time frame: baseline, 12th and 24th weeks after intervention

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 27, 2016
Registry last updated
Mar 14, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.