Mild Cognitive ImpairmentReMemory-MCINCT02592187
A Cognitive Training Tool Based on Life-logging in Mild Cognitive Impairment (ReMemory-MCI)
A study testing ReMemory-MCI training in people with Mild Cognitive Impairment, run by Consorci Sanitari de Terrassa.
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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- ReMemory-MCI training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
About this study
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.
Read more
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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- ReMemory-MCI training, Control intervention
- Keywords
- Life-logging, Cognitive Training, Mild Cognitive Impairment, Memory, Information and communications technology (ICT) in healthcare, Portable camera
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReMemory-MCI trainingBehavioural
Control interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Experimental intervention | Experimental | ReMemory-MCI training Receives: Behavioral: ReMemory-MCI training |
| Control intervention | Active comparator | Control intervention Receives: Behavioral: Control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 16 sessions treatment and 3 months
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)
Measured: after 16 sessions treatment and 3 months
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).
Measured: after 16 sessions treatment and 3 months
Change in executive function, set-shifting after receiving treatment
Set-shifting was measured using the Colors Trails Test
Measured: after 16 sessions treatment and 3 months
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
Measured: after 16 sessions treatment and 3 months
Change in executive function, inhibition after receiving treatment
Inhibition was measured using the Five Digit Test
Measured: after 16 sessions treatment and 3 months
Change in processing speed after receiving treatment
Processing speed was measured using the Detection Task from the computerized neurocognitive battery Cogstate battery
Measured: after 16 sessions treatment and 3 months
Secondary outcomes (9)
Change in subjective memory complaints after receiving treatment
subjective memory complaints was measured using Memory Faiures of EveryDay (MFE) Test
Measured: after 16 sessions treatment and 3 months
Change in functional capacity after receiving treatment
Functional capacity was measured using Functional Assessment Questionnaire (FAQ) and the UCSD Performance-Based Skills Assessment (UPSA).
Measured: after 16 sessions treatment and 3 months
Change in depression and anxiety after receiving treatment
depression and anxiety were measured using the Hospital Anxiety and Depression Scale (HADS)
Measured: after 16 sessions treatment and 3 months
Change in quality of life
Quality of life was measured using Quality of Life-Alzheimer Disease (QoL-AD)
Measured: after 16 sessions treatment and 3 months
Change in Neuropsychiatric symptoms
Neuropsychiatric symptoms was measured using Neuropsychiatric Inventory Questionnaire (NPI)
Measured: after 16 sessions treatment and 3 months
Change in Caregiver Burden
Caregiver Burden was measured using the Zarit Caregiver Burden Scale
Measured: after 16 sessions treatment and 3 months
Change in patient's self-esteem
Self-Esteem was measured using the Rosenberg Self-Esteem Scale
Measured: after 16 sessions treatment and 3 months
Change in patient and caregiver's perception of social support
Perception of social support was measured using the Duke-UNC Functional Social Support Questionnaire
Measured: after 16 sessions treatment and 3 months
Change in neuroplasticiy
neuroplasticiy was measured using Brain-derived neutrophic factor (BDNF) serum levels
Measured: after 16 sessions treatment and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startJun 2015
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Barcelona, Associació Vallès Amics de la Neurologia, Fundació La Marató de TV3
- Responsible party
- Principal investigator, Maite Garolera, Consorci Sanitari de Terrassa
- Investigators
- Maite Garolera, PhD, Principal investigator, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592187
- Sponsor's protocol ID
- Fundacio la MaratóTV3 20141510
- Acronym
- ReMemory-MCI
- Status last verified
- Jan 2019
- First submitted
- 31 Jul 2015
- Last updated
- 11 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cognitive Training Tool Based on Life-logging in Mild Cognitive Impairment (ReMemory-MCI)
- ClinicalTrials.gov ID
- NCT02592187
- Acronym / sponsor ID
- ReMemory-MCI / Fundacio la MaratóTV3 20141510
- Conditions
- Mild Cognitive Impairment
- Keywords
- Life-logging, Cognitive Training, Mild Cognitive Impairment, Memory, Information and communications technology (ICT) in healthcare, Portable camera
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Collaborators
- University of Barcelona, Associació Vallès Amics de la Neurologia, Fundació La Marató de TV3
- Study start
- Jun 2015
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental intervention | Experimental | Behavioral: ReMemory-MCI trainingReMemory-MCI training |
| Control intervention | Active comparator | Behavioral: Control interventionControl intervention |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReMemory-MCI training | Behavioural | Experimental intervention |
| Control intervention | Behavioural | Control intervention |
Primary outcome
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.
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)
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).
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
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
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
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
9 secondary outcomes
Change in subjective memory complaints after receiving treatment
Time frame: after 16 sessions treatment and 3 months
Change in functional capacity after receiving treatment
Time frame: after 16 sessions treatment and 3 months
Change in depression and anxiety after receiving treatment
Time frame: after 16 sessions treatment and 3 months
Change in quality of life
Time frame: after 16 sessions treatment and 3 months
Change in Neuropsychiatric symptoms
Time frame: after 16 sessions treatment and 3 months
Change in Caregiver Burden
Time frame: after 16 sessions treatment and 3 months
Change in patient's self-esteem
Time frame: 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
Change in neuroplasticiy
Time frame: after 16 sessions treatment and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maite Garolera, PhD principal investigator
Consorci Sanitari de Terrassa
Questions about this trial
What is this clinical trial studying?
A study testing ReMemory-MCI training in people with Mild Cognitive Impairment, run by Consorci Sanitari de Terrassa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in memory after receiving treatment (time frame: after 16 sessions treatment and 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.