NCT03195803

Brief Summary

This is a non-pharmacological study evaluating the differential effects of a computerized cognitive stimulation program according to the existence or not of white matter hyperintensities in elderly with mild cognitive impairment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Status
completed

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

October 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
Last Updated

June 22, 2017

Status Verified

June 1, 2017

Enrollment Period

1.5 years

First QC Date

June 14, 2017

Last Update Submit

June 20, 2017

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • Rey Auditory Verbal Learning test

    Assessment of verbal learning in episodic memory

    Baseline assessment, change from Baseline on Rey Auditory Verbal Learning test at 3 months immediately after intervention and at 3 months follow-up

Study Arms (2)

MCI with WMH

EXPERIMENTAL

Computerized Cognitive Stimulation was administered to this group, twice a week.

Behavioral: Computerized Cognitive Stimulation

MCI without WMH

ACTIVE COMPARATOR

Computerized Cognitive Stimulation was administered to this group, twice a week.

Behavioral: Computerized Cognitive Stimulation

Interventions

Computerized Cognitive StimulationBEHAVIORAL

All participants performed 12-week, 60-minutes twice a week of a computer-based cognitive stimulation program in group-setting, using a tablet with a software with specific training focused on attention, executive and speed processing functions.

MCI with WMHMCI without WMH

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Mild Cognitive Impairment
  • With and without white matter hyperintensities
  • MRI available or accept to perform one
  • No engagement in other cognitive intervention program

You may not qualify if:

  • Psychiatric and neurological disorders
  • History of alcohol or other substance abuse
  • Sensory and/or motor deficit affecting the use of a tablet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Anne-Sophie AR RIGAUD, Professor

    Broca University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Comparison, non-randomized single blind study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

June 14, 2017

First Posted

June 22, 2017

Study Start

October 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

June 22, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share