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

Mild Cognitive Impairment Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03195816
• Other study ID #: LUS3WMH
• Status: Not yet recruiting
• Phase: N/A
• First received: June 14, 2017
• Last updated: June 20, 2017
• Start date: January 2018
• Est. completion date: March 2019

Study information

• Verified date: June 2017
• Source: Broca Hospital
• Contact: Anne-Sophie AR RIGAUD, Professor
• Phone: 00 33 1440835 03
• Email: anne-sophie.rigaud[@]brc.aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: March 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Leila DJABELKHIR

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change on Rey Auditory Verbal Learning test	Assessment of verbal learning in episodic memory	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
Secondary	Change on Fazekas scale	Assessment of white matter hyperintentisites severity on MRI	Baseline assessment of WMH severity and evolution at 12 months immediately after intervention