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A Computer-based Cognitive Stimulation in Mild Cognitive Impairment With White Matter Hyperintensities

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03195816
Recruitment Status : Unknown
Verified June 2017 by Leila DJABELKHIR, Broca Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Information provided by (Responsible Party):
Leila DJABELKHIR, Broca Hospital

Brief Summary:
This is a non-pharmacological study evaluating the impact of a computerized cognitive stimulation program on verbal learning and on the progression white matter hyperintensities in elderly with mild cognitive impairment.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: Computerized Cognitive training Not Applicable

Detailed Description:
White matter hyperintensities (WMH) can appear in Mild Cognitive Impairment (MCI) and have been associated to executive, attention and processing speed deficits. Some findings indicate that the presence of WMH may contribute to Alzheimer's disease (AD) in addition to ß-amyloid, suggesting a greater vulnerability of MCI. One important challenge is to prevent or slowing down the progression of WMH. Few studies investigated the effects of computerized cognitive interventions in MCI with WMH, which deserve special attention. This study aim to investigate the effects of an intensive computer-based cognitive stimulation (CCS) program on the verbal learning in episodic memory in MCI with WMH and to explore the effects on the progression of WMH at 1-year interval.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparison between experimental group and control group.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of a Computer-based Cognitive Stimulation on the Verbal Learning and the Progression of White Matter Hyperintensities in Mild Cognitive Impairment: A Protocol for a Randomized Controlled Trial.
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Arm Intervention/treatment
Experimental: computerized Cognitive training
Experimental group will receive 1 year of a computer-based cognitive stimulation program.
Behavioral: Computerized Cognitive training
Experimental group will receive 1 year of a computer-based cognitive stimulation program, first 6 months, 60-minutes twice a week and next 6 months once a week training in group-setting, using a tablet with a software with specific training focused on attention, executive and speed processing functions.

No Intervention: MCI control group
The control group will receive a usual standard care without engagement in intervention

Primary Outcome Measures :
  1. Change on Rey Auditory Verbal Learning test [ Time Frame: Baseline assessment in 3-weeks period before intervention, change from baseline at 6-months immediately after the end intervention, and after 3-months follow-up ]
    Assessment of verbal learning in episodic memory

Secondary Outcome Measures :
  1. Change on Fazekas scale [ Time Frame: Baseline assessment of WMH severity and evolution at 12 months immediately after intervention ]
    Assessment of white matter hyperintentisites severity on MRI

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Psychiatric and neurological disorders
  • History of alcohol or other substance consumption
  • Sensory and or motor deficit that could interfere with the use of computer tool
  • Refusal MRI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03195816

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Contact: Anne-Sophie AR RIGAUD, Professor 00 33 1440835 03
Contact: Leila LD DJABELKHIR, Neuropsychologist 00 33 6042305

Sponsors and Collaborators
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Principal Investigator: Anne-Sophie AR RIGAUD, Professor Broca University Hospital

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Responsible Party: Leila DJABELKHIR, PhD candidate, Broca Hospital Identifier: NCT03195816    
Other Study ID Numbers: LUS3WMH
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leila DJABELKHIR, Broca Hospital:
Mild Cognitive Impairment
white matter hyperintensities
computerized cognitive training
brain plasticity
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders