NCT02592187

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

January 11, 2019

Status Verified

January 1, 2019

Enrollment Period

3.7 years

First QC Date

July 31, 2015

Last Update Submit

January 9, 2019

Conditions

Mild Cognitive Impairment

Keywords

Life-loggingCognitive TrainingMild Cognitive ImpairmentMemoryInformation and communications technology (ICT) in healthcarePortable camera

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • Change in executive function, inhibition after receiving treatment

    Inhibition was measured using the Five Digit Test

    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

    after 16 sessions treatment and 3 months

Secondary Outcomes (9)

  • Change in subjective memory complaints after receiving treatment

    after 16 sessions treatment and 3 months

  • Change in functional capacity after receiving treatment

    after 16 sessions treatment and 3 months

  • Change in depression and anxiety after receiving treatment

    after 16 sessions treatment and 3 months

  • Change in quality of life

    after 16 sessions treatment and 3 months

  • Change in Neuropsychiatric symptoms

    after 16 sessions treatment and 3 months

  • +4 more secondary outcomes

Study Arms (2)

Experimental intervention

EXPERIMENTAL

ReMemory-MCI training

Behavioral: ReMemory-MCI training

Control intervention

ACTIVE COMPARATOR

Control intervention

Behavioral: Control intervention

Interventions

ReMemory-MCI trainingBEHAVIORAL
Experimental intervention
Control interventionBEHAVIORAL
Control intervention

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Maite Garolera, PhD

    Consorci Sanitari de Terrassa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 31, 2015

First Posted

October 30, 2015

Study Start

June 1, 2015

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

January 11, 2019

Record last verified: 2019-01