Mild Cognitive ImpairmentNCT03195816
A Computer-based Cognitive Stimulation in Mild Cognitive Impairment With White Matter Hyperintensities
A study testing Computerized Cognitive training in people with Mild Cognitive Impairment, run by Leila DJABELKHIR.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Computerized Cognitive training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Computerized Cognitive training
- Keywords
- Mild Cognitive Impairment, white matter hyperintensities, computerized cognitive training, brain plasticity
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Cognitive trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| computerized Cognitive training | Experimental | Experimental group will receive 1 year of a computer-based cognitive stimulation program. Receives: Behavioral: Computerized Cognitive training |
| MCI control group | No intervention | The control group will receive a usual standard care without engagement in intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on Rey Auditory Verbal Learning test
Assessment of verbal learning in episodic memory
Measured: 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 outcomes (1)
Change on Fazekas scale
Assessment of white matter hyperintentisites severity on MRI
Measured: Baseline assessment of WMH severity and evolution at 12 months immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study startJan 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison between experimental group and control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leila DJABELKHIR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Leila DJABELKHIR, Broca Hospital
- Investigators
- Anne-Sophie AR RIGAUD, Professor, Principal investigator, Broca University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195816
- Sponsor's protocol ID
- LUS3WMH
- Status last verified
- Jun 2017
- First submitted
- 14 Jun 2017
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03195816
- Acronym / sponsor ID
- LUS3WMH
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, white matter hyperintensities, computerized cognitive training, brain plasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Leila DJABELKHIRUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Comparison between experimental group and control group.
| Arm | Type | Receives |
|---|---|---|
| computerized Cognitive training | Experimental | Behavioral: Computerized Cognitive trainingExperimental group will receive 1 year of a computer-based cognitive stimulation program. |
| MCI control group | No intervention | –The control group will receive a usual standard care without engagement in intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Cognitive trainingExperimental 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. | Behavioural | computerized Cognitive training |
Primary outcome
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
1 secondary outcome
Change on Fazekas scale
Time frame: Baseline assessment of WMH severity and evolution at 12 months immediately after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Sophie AR RIGAUD, Professor principal investigator
Broca University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Cognitive training in people with Mild Cognitive Impairment, run by Leila DJABELKHIR.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Sophie AR RIGAUD, Professor (00 33 1440835 03, anne-sophie.rigaud@brc.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.