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Clinical Trials/NCT03195816
NCT03195816
Unknown
N/A

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.

Leila DJABELKHIR0 sites90 target enrollmentJanuary 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
Leila DJABELKHIR
Enrollment
90
Primary Endpoint
Change on Rey Auditory Verbal Learning test
Last Updated
8 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 2018
End Date
March 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Leila DJABELKHIR
Responsible Party
Sponsor Investigator
Principal Investigator

Leila DJABELKHIR

PhD candidate

Broca Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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 Outcomes

  • Change on Fazekas scale(Baseline assessment of WMH severity and evolution at 12 months immediately after intervention)

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