Clinical trial NCT03430401: Computer-based Cognitive Rehabilitation Program for Healthy Older Adults, Older People With Mild Cognitive Impairment and Mild Dementia
Official title: Computer-based Cognitive Rehabilitation Program to Improve Cognition and Delay Deterioration in Functional Performance for Healthy Older Adults, Older People With Mild Cognitive Impairment and Mild Dementia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Mild Dementia
Healthy Older Adults
Keywords: memory encoding
functional performance
Lead sponsor: University of Western Sydney
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will adopt a newly developed computer-based cognitive rehabilitation program targeting the encoding stage of memory. The aims of the study are:

1. To test the feasibility of conducting a newly developed computer-based cognitive rehabilitation program for healthy older adults, people with MCI and mild dementia.
2. To test the effectiveness of the newly developed program in improving cognitive function and enabling maintenance of occupational performance in healthy older adults, people with MCI or mild dementia.

Using an iPad application, study participants will learn a memory encoding strategy to support completion of their daily activities. By implementing memory encoding strategies during the mild stages of cognitive decline, the project aims to prolong independence in functional performance. It is anticipated that adoption of the same memory strategies will enable maintain performance as they may experience ongoing cognitive decline.

Detailed description: This study extends on the positive results of a pilot study (Lim et al., 2012) which demonstrated the effectiveness of a cognitive training program combined with perceptual and semantic memory encoding strategies. Following the intervention phase of the pilot study, elements of cognition were examined using standardised assessments. The participants showed improved general attention (p = 0.03), memory (p = 0.03) and cognitive function including naming (p = 0.02), construction (p = 0.01), memory (p = 0.02) and similarities (p = 0.001) all of which are necessary for functioning in daily activities. However, due to the combination of strategies used during the pilot study, the isolated effect of perceptual and semantic memory encoding strategies could not be determined. It has been found that the effects of aging impact negatively on both semantic and perceptual encoding. However, with age, there tends to be a greater impact on an individual's ability to use perceptual encoding strategies in comparison to those of semantic (Kuo, Liu, Ting, \& Chan, 2014). This varies in the case of individuals in the early stages of Alzheimer's disease in which many individuals will show progressive impairment in semantic memory (Hodges \& Patterson, 1995). As dementia has been positively correlated with Mild Cognitive Impairment (MCI) but not often diagnosed until much later in the course of the disease and as not all individuals with MCI will progress to dementia it would be beneficial prior to undertaking a memory encoding intervention program to understand if an individual would benefit greater from undertaking a semantic or a perceptual memory encoding rehabilitation approach. Although it may be easy for a healthy adult to report their preference in encoding style, an individual with MCI or mild dementia may find this more difficult due to the abstract complexity of the concepts. As it is known that not all cases of MCI progress to dementia, this study aims at identifying if individuals with MCI or mild dementia will benefit from intervention based on both semantic and perceptual encoding styles.

In addition, given the benefit and successful use of computer-based programs in elderly, this study will develop the memory encoding training program into a user-friendly computer-based program in healthy older adults, older adults with MCI or mild dementia will be able to use under the guidance of rehabilitation professionals.

Eligibility criteria: Selection Criteria for healthy older adults:

1. Score greater than 24 on the Mini-Mental State Examination, 2nd edition, standard version (MMSE)
2. Score less than 5 on the 15-item Geriatric Depression Scale - Short Form (GDS)
3. No diagnosis of probable dementia (as per NINCDS-ADRDA Alzheimer's Criteria); and
4. Are able to provide voluntary consent to participate in the study.

Selection Criteria for people with MCI:

1. No diagnosis of probable dementia (as per NINCDS-ADRDA Alzheimer's Criteria);
2. Have a Clinical Dementia Rating Score (CDR) of 0 indicating no dementia;
3. Meets the diagnostic criteria for MCI (Petersen, 2004); and
4. Are able to provide voluntary consent to participate in the study.

Selection Criteria for people with mild dementia:

1. Have a diagnosis of probable dementia;
2. Have a CDR score of 1 indicating mild dementia;
3. Have a career or family members who are able to report functional performance; and
4. Are able to provide voluntary consent to participate in the study, or have a guardian to provide consent.

Primary outcomes:
measure: Disability Assessment for Dementia - Change from baseline after the intervention
timeFrame: Baseline and after the intervention (12 weeks)
measure: Lawton and Brody Instrumental Activities of Daily Living Scale - Change from baseline after the intervention
timeFrame: Baseline and after the intervention (12 weeks)
Secondary outcomes:
measure: Color Trails Test - Change from baseline after the intervention
timeFrame: Baseline and after the intervention (12 weeks)
measure: Repeatable Battery for the Assessment of Neuropsychological Status - Change from baseline after the intervention
timeFrame: Baseline and after the intervention (12 weeks)
measure: Behavior Rating Inventory of Executive Function - Change from baseline after the intervention
timeFrame: Baseline and after the intervention (12 weeks)
Other outcomes:
Locations:
city: Penrith
country: Australia
facility: Western Sydney University
state: New South Wales
Study officials:
affiliation: Western Sydney University
name: Karen P.Y. Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: