NCT03408509

Brief Summary

Cognition encompasses memory, attention, language and other brain capacities that are necessary for good quality of life and independence. Age-related cognitive decline starts at the third decade of life and in some cases can start to impact daily functioning in the late forties. Dementia is the most devastating consequence associated with age-related cognitive decline. Recent studies indicate that improving cognition by means of intensive computerized brain training can mitigate some aspects of agerelated cognitive decline, and may even have a role in preventing or delaying dementia onset. Critically, the capacity of a given individual to improve their cognitive performance after training is fundamentally related to engagement with the exercises. Currently, little is known about how to apply intensive computerized cognitive training effectively in the health system, ensuring engagement and best progress. This project aims to tackle this challenge by developing, applying and testing personalized approaches to implement cognitive training in daily life of older adults that were recently evaluated at Memory Clinics and their care partners. The community readiness approach will be implemented using semi-structured interviews, conducted with subjects that may be interested in cognitive training, key informant, and key stakeholders. Using this information, the investigators will design an individualized training program and follow up its application in a feasibility trial. Twenty participants, recently evaluated at different Memory Clinics in Ireland, will be recruited, interviewed and invited to engage, over the ensuing 2 to 3 months, in computerized cognitive training. Subjects will be assessed after completion of the intervention for training adherence and individual gains on the computerized exercises. In order to gain insight about regional specificities of the approach the investigators will perform a parallel project using the same methodology in Brazil. This project is expected to inform the future implementation of cognitive training in public health policies for older adults.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

January 12, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

January 12, 2018

Last Update Submit

January 24, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Engagement

    will be defined as a continuous variable (number of hours of training completed by the participant).

    3 months

Secondary Outcomes (4)

  • Individual gains on the computerized exercises

    3 months

  • Quantitative measure of motivation with the computerized training exercise

    3 months

  • Qualitative motivation with the computerized training exercise

    3 months

  • Training adherence (dichotomic variable)

    3 months

Study Arms (1)

Cognitive training

EXPERIMENTAL
Behavioral: Computerized cognitive training

Interventions

Posit Science Inc. will supply the software for the computerized cognitive training through the platform BrainHQ, which is available on line. The training program consists of a set of computerized exercises designed to improve the speed and accuracy of sensory information processing while engaging neuromodulatory systems involved in attention and reward. The rationale is that, in order to understand and remember information, the brain must first generate precise and reliable neurological responses that represent the sensory stimuli. These exercises continuously adjust the difficulty level to user performance to maintain an approximately 85% rate of correct responses. Trials with correct responses are rewarded with points and animations. The goal is to increase the effectiveness with which these stimuli engage and drive plastic changes in brain systems. Engagement is monitored by electronic data upload following each training session.

Cognitive training

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being evaluated at a memory clinic in the last year, or be the care partner of a person evaluated at a memory clinic
  • Adequate visual and auditory acuity to allow practice on the computerized training exercises
  • Physical ability sufficient to allow performance of the computerized training exercises
  • Provide signed and dated informed consent form.
  • Willing to comply with all study procedures and be available for the duration of the study.

You may not qualify if:

  • Any medical condition that precludes performing the computerized training exercises
  • Advanced dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St James Hospital

Dublin, D8, Ireland

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Rogerio A Panizzutti, M.D., Ph.D.

CONTACT

Andrea Fantinatti, B.Sc.

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 24, 2018

Study Start

January 12, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

January 26, 2018

Record last verified: 2018-01

Locations