Mild Cognitive ImpairmentNCT03195803
Cognitive Intervention in Mild Cognitive Impairment With or Without White Matter Hyperintensities
A study testing Computerized Cognitive Stimulation in people with Mild Cognitive Impairment, run by Leila DJABELKHIR.
Trial 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. 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 Stimulation
- 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
- 51 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Apr 2017
- 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 white matter hyperintensities
- MRI 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 abuse
- Sensory and/or motor deficit affecting the use of a tablet
About this study
Official title: Evaluation of Differential Effects of a Computer-based-cognitive Intervention on Cognition Among Elderly With Mild Cognitive Impairment With and Without White Matter Hyperintensities: A Comparative Study.
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.
Read the detailed description
White matter hyperintensities (WMH) are increasingly recognized as a factor determining the heterogeneity of Mild Cognitive Impairment (MCI) and have been associated to executive and processing speed impairment. Cognitive interventions in MCI remain quite limited for these MCI with vascular profile and studies often distinguish patients by clinical subtypes rather than brain profile before an intervention. Considering magnetic resonance imaging (MRI) data, this study investigated the effects of a computer-based cognitive stimulation (CCS) program on MCI with WMH compared to MCI without WMH.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Computerized Cognitive Stimulation
- 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 StimulationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MCI with WMH | Experimental | Computerized Cognitive Stimulation was administered to this group, twice a week. Receives: Behavioral: Computerized Cognitive Stimulation |
| MCI without WMH | Active comparator | Computerized Cognitive Stimulation was administered to this group, twice a week. Receives: Behavioral: Computerized Cognitive Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rey Auditory Verbal Learning test
Assessment of verbal learning in episodic memory
Measured: Baseline assessment, change from Baseline on Rey Auditory Verbal Learning test at 3 months immediately after intervention and at 3 months follow-up
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 startOct 2015
- Primary completionApr 2017
- Study completionApr 2017
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Comparison, non-randomized single blind study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
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
- NCT03195803
- Sponsor's protocol ID
- LUS2WMH
- 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
- Evaluation of Differential Effects of a Computer-based-cognitive Intervention on Cognition Among Elderly With Mild Cognitive Impairment With and Without White Matter Hyperintensities: A Comparative Study.
- ClinicalTrials.gov ID
- NCT03195803
- Acronym / sponsor ID
- LUS2WMH
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Leila DJABELKHIRUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- 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 differential effects of a computerized cognitive stimulation program according to the existence or not of white matter hyperintensities in elderly with mild cognitive impairment.
Detailed description
White matter hyperintensities (WMH) are increasingly recognized as a factor determining the heterogeneity of Mild Cognitive Impairment (MCI) and have been associated to executive and processing speed impairment. Cognitive interventions in MCI remain quite limited for these MCI with vascular profile and studies often distinguish patients by clinical subtypes rather than brain profile before an intervention. Considering magnetic resonance imaging (MRI) data, this study investigated the effects of a computer-based cognitive stimulation (CCS) program on MCI with WMH compared to MCI without WMH.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Comparison, non-randomized single blind study
| Arm | Type | Receives |
|---|---|---|
| MCI with WMH | Experimental | Behavioral: Computerized Cognitive StimulationComputerized Cognitive Stimulation was administered to this group, twice a week. |
| MCI without WMH | Active comparator | Behavioral: Computerized Cognitive StimulationComputerized Cognitive Stimulation was administered to this group, twice a week. |
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 white matter hyperintensities
- MRI available or accept to perform one
- No engagement in other cognitive intervention program
Key exclusion criteria (3 listed)
- Psychiatric and neurological disorders
- History of alcohol or other substance abuse
- Sensory and/or motor deficit affecting the use of a tablet
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 StimulationAll 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. | Behavioural | MCI with WMH, MCI without WMH |
Primary outcome
Rey Auditory Verbal Learning test
Time frame: Baseline assessment, change from Baseline on Rey Auditory Verbal Learning test at 3 months immediately after intervention and at 3 months follow-up
Assessment of verbal learning in episodic memory
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Mild Cognitive Impairment
Recruiting
The Efficacy of an IADL-based Non-immersive Virtual Reality Training Program to Enhance ADL Performance and Cognitive Function for Persons at Risk of Dementia
Cognitive Enhancement, Subjective Cognitive Decline (SCD)
RecruitingPhase 2
Alzheimer's Tau Platform: Master Protocol
Preclinical Alzheimer's Disease, Alzheimer Disease
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Fuzhou Aging Brain Health Initiative
Dementia, Alzheimer Dementia (AD)
Recruiting
Choose Myself (Before) Losing Myself
Dementia (Diagnosis), Mild Cognitive Impairment
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 Stimulation 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 3 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rey Auditory Verbal Learning test (time frame: Baseline assessment, change from Baseline on Rey Auditory Verbal Learning test at 3 months immediately after intervention and at 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.