A Cognitive Training Tool Based on Life-logging in Mild Cognitive Impairment (ReMemory-MCI)

Mild Cognitive Impairment Clinical Trial

— ReMemory-MCI  

Official title:

A Cognitive Training Tool Based on Life-logging in Mild Cognitive Impairment (ReMemory-MCI)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02592187
• Other study ID #: Fundacio la MaratóTV3 20141510
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2015
• Est. completion date: February 2019

Study information

• Verified date: January 2019
• Source: Consorci Sanitari de Terrassa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• ReMemory-MCI training

• Control intervention

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Consorci Sanitari de Terrassa	Associació Vallès Amics de la Neurologia, Fundació La Marató de TV3, University of Barcelona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in memory after receiving treatment	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
Primary	Change in attention after receiving treatment	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
Primary	Change in working memory after receiving treatment	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
Primary	Change in executive function, set-shifting after receiving treatment	Set-shifting was measured using the Colors Trails Test	after 16 sessions treatment and 3 months
Primary	Change in executive function,verbal fluency	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
Primary	Change in executive function, inhibition after receiving treatment	Inhibition was measured using the Five Digit Test	after 16 sessions treatment and 3 months
Primary	Change in processing speed after receiving treatment	Processing speed was measured using the Detection Task from the computerized neurocognitive battery Cogstate battery	after 16 sessions treatment and 3 months
Secondary	Change in subjective memory complaints after receiving treatment	subjective memory complaints was measured using Memory Faiures of EveryDay (MFE) Test	after 16 sessions treatment and 3 months
Secondary	Change in functional capacity after receiving treatment	Functional capacity was measured using Functional Assessment Questionnaire (FAQ) and the UCSD Performance-Based Skills Assessment (UPSA).	after 16 sessions treatment and 3 months
Secondary	Change in depression and anxiety after receiving treatment	depression and anxiety were measured using the Hospital Anxiety and Depression Scale (HADS)	after 16 sessions treatment and 3 months
Secondary	Change in quality of life	Quality of life was measured using Quality of Life-Alzheimer Disease (QoL-AD)	after 16 sessions treatment and 3 months
Secondary	Change in Neuropsychiatric symptoms	Neuropsychiatric symptoms was measured using Neuropsychiatric Inventory Questionnaire (NPI)	after 16 sessions treatment and 3 months
Secondary	Change in Caregiver Burden	Caregiver Burden was measured using the Zarit Caregiver Burden Scale	after 16 sessions treatment and 3 months
Secondary	Change in patient's self-esteem	Self-Esteem was measured using the Rosenberg Self-Esteem Scale	after 16 sessions treatment and 3 months
Secondary	Change in patient and caregiver's perception of social support	Perception of social support was measured using the Duke-UNC Functional Social Support Questionnaire	after 16 sessions treatment and 3 months
Secondary	Change in neuroplasticiy	neuroplasticiy was measured using Brain-derived neutrophic factor (BDNF) serum levels	after 16 sessions treatment and 3 months