- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02592187
A Cognitive Training Tool Based on Life-logging in Mild Cognitive Impairment (ReMemory-MCI) (ReMemory-MCI)
Background: Mild Cognitive Impairment (MCI) is a risk factor for dementia and represents a critical window of opportunity to intervene and alter the trajectory of both cognitive and functional decline. Emerging life-logging technologies has shown a tremendous potential to increase autobiographical memory.
Objective: The main goal of the present study is to develop a Cognitive Training program (CT) for MCI based on life-logging captured by a Wearable Camera (WeC) recording specific autobiographical episodes for stimulating posteriorly episodic memory. The challenge is to create an application to manage this large collection of images, which can be easily retrieved as events by users in a therapeutic context as a multimodal cognitive stimulation. The investigators will conduct a quasi-experimental design with non-equivalent control group, evaluating the effectiveness of the life-logging re-experiencing program immediately and 3-month follow-up period.
Methodology: The design is a pretest, posttest and follow-up design, where 30 adults with MCI were sequentially allocated to one of two conditions: intervention or control group. All subjects wore a lifelogging WeC during two weeks, and subsequently they were generated several videos with the most relevant information of each event. Subjects in the Intervention Group will attend 1-hour individual training sessions 2 times per week for 14 8 weeks. Main outcomes measures will be cognitive, functional, emotional and quality of life measures, as well as biochemical measures (BDNF).
Expected results: The investigators expect the outcomes to provide preliminary evidence that autobiographical experimentation CT programs can positively impact cognitive functioning and may represent an effective strategy to improve memory and functionality in those who begun to experience cognitive decline.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 65-90 years of age
- Meet definition criteria for MCI (Petersen, 2004)
- Be receiving CT at least three month in Day Hospital during three months or more; c) having memory complaint, usually verified by an informant
- Having memory complaint, usually verified by an informant
- Memory performance below the mean score for the corresponding age and education group
- Having normal general cognitive functioning as determined by a Mini-Mental State Examination (MMSE) score > o = 24
- Having a reliable caregiver who can supervise the patient's daily activities
- Having Global clinical dementia rating scale score of 0.5
- Granted written informed consent accepting to participate in the study
Exclusion Criteria:
- Neurological, psychiatric or unstable medical disorders
- Intellectual deficiency (Premorbid Intellectual Quotient (IQ) -Vocabulary- less 85)
- Relevant hearing, vision, motor or language deficits
- Less than 4 years of education e) acquisition of Catalonian or Spanish languages after 15 years old
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental intervention
ReMemory-MCI training
|
|
ACTIVE_COMPARATOR: Control intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in memory after receiving treatment
Time Frame: after 16 sessions treatment and 3 months
|
Memory was measured using the Logical Memory Test from the Wechsler Memory Scale, IV version (WMS-IV, Spanish version); the International Shopping List Task and the One Card Learning Task from the computerized neurocognitive battery Cogstate.
|
after 16 sessions treatment and 3 months
|
Change in attention after receiving treatment
Time Frame: after 16 sessions treatment and 3 months
|
Attention was measured using the Identification Task from the computerized neurocognitive battery Cogstate and the Forward Digit Span from the Wechsler Adult Intelligence Scale, fourth edition (WAIS-IV)
|
after 16 sessions treatment and 3 months
|
Change in working memory after receiving treatment
Time Frame: after 16 sessions treatment and 3 months
|
orking memory was measured using the One Back Task from the computerized neurocognitive battery Cogstate and the Backward Digit Span from the Wechsler Adult Intelligence Scale, fourth edition (WAIS-IV).
|
after 16 sessions treatment and 3 months
|
Change in executive function, set-shifting after receiving treatment
Time Frame: after 16 sessions treatment and 3 months
|
Set-shifting was measured using the Colors Trails Test
|
after 16 sessions treatment and 3 months
|
Change in executive function,verbal fluency
Time Frame: after 16 sessions treatment and 3 months
|
erbal Fluency was measured using the Controlled Oral Word Association Test, spanish adaptation, and semantic fluency test using the category Animals
|
after 16 sessions treatment and 3 months
|
Change in executive function, inhibition after receiving treatment
Time Frame: after 16 sessions treatment and 3 months
|
Inhibition was measured using the Five Digit Test
|
after 16 sessions treatment and 3 months
|
Change in processing speed after receiving treatment
Time Frame: after 16 sessions treatment and 3 months
|
Processing speed was measured using the Detection Task from the computerized neurocognitive battery Cogstate battery
|
after 16 sessions treatment and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in subjective memory complaints after receiving treatment
Time Frame: after 16 sessions treatment and 3 months
|
subjective memory complaints was measured using Memory Faiures of EveryDay (MFE) Test
|
after 16 sessions treatment and 3 months
|
Change in functional capacity after receiving treatment
Time Frame: after 16 sessions treatment and 3 months
|
Functional capacity was measured using Functional Assessment Questionnaire (FAQ) and the UCSD Performance-Based Skills Assessment (UPSA).
|
after 16 sessions treatment and 3 months
|
Change in depression and anxiety after receiving treatment
Time Frame: after 16 sessions treatment and 3 months
|
depression and anxiety were measured using the Hospital Anxiety and Depression Scale (HADS)
|
after 16 sessions treatment and 3 months
|
Change in quality of life
Time Frame: after 16 sessions treatment and 3 months
|
Quality of life was measured using Quality of Life-Alzheimer Disease (QoL-AD)
|
after 16 sessions treatment and 3 months
|
Change in Neuropsychiatric symptoms
Time Frame: after 16 sessions treatment and 3 months
|
Neuropsychiatric symptoms was measured using Neuropsychiatric Inventory Questionnaire (NPI)
|
after 16 sessions treatment and 3 months
|
Change in Caregiver Burden
Time Frame: after 16 sessions treatment and 3 months
|
Caregiver Burden was measured using the Zarit Caregiver Burden Scale
|
after 16 sessions treatment and 3 months
|
Change in patient's self-esteem
Time Frame: after 16 sessions treatment and 3 months
|
Self-Esteem was measured using the Rosenberg Self-Esteem Scale
|
after 16 sessions treatment and 3 months
|
Change in patient and caregiver's perception of social support
Time Frame: after 16 sessions treatment and 3 months
|
Perception of social support was measured using the Duke-UNC Functional Social Support Questionnaire
|
after 16 sessions treatment and 3 months
|
Change in neuroplasticiy
Time Frame: after 16 sessions treatment and 3 months
|
neuroplasticiy was measured using Brain-derived neutrophic factor (BDNF) serum levels
|
after 16 sessions treatment and 3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fundacio la MaratóTV3 20141510
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