Mild Cognitive ImpairmentNCT03883308
The Influence of Multi-domain Cognitive Training on Large-scale Structural and Functional Brain Networks in MCI
A study testing Multi-domain cognitive training and Cross-word puzzle training in people with Mild Cognitive Impairment, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to integrate advanced computational techniques and multimodal neuroimaging methods to examine the potential effects of long-term, multi-domain, online, computerized cognitive training on large-scale structural and functional brain networks in older adults with mild cognitive impairment… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Multi-domain cognitive training and Cross-word puzzle training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2017to 1 Dec 2020
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Cognitive concern by subject, informant or physician
- Impairment in memory domain (delayed recall of one paragraph from Logical Memory II subscale from Wechsler memory Scale - Revised with cutoff scores of <=8, <=4 and <=2 for 16, 8-15 and 0-7 years of education)
- Essentially normal functional activities
- Mini-Mental State Examination (MMSE) scores >=24
- Stability of permitted medications (e.g. cholinesterase inhibitors, hypertension medication, etc.) for at least two months.
Who cannot join
- Any significant neurological condition including probable dementia, Parkinson's disease, Huntington's disease, multiple sclerosis, and brain tumor, among others.
- Presence of Axis I disorder
- Current use of psychoactive medications except for the permitted medications.
- Claustrophobia
- MRI contraindication
- Any significant systemic or unstable medical condition which could lead to difficulty complying with the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
The purpose of this study is to integrate advanced computational techniques and multimodal neuroimaging methods to examine the potential effects of long-term, multi-domain, online, computerized cognitive training on large-scale structural and functional brain networks in older adults with mild cognitive impairment (MCI).
Read the detailed description
This multilevel study will be comprised of a placebo controlled randomized controlled trial to test the effect of long-term (6 months), multi-domain, computerized cognitive training on large-scale structural and functional brain networks in individuals with MCI (age >= 65 years). Neuroimaging and neuropsychological data before and after intervention will be evaluated within and between groups to elucidate the trajectory of neuronal network improvements associated with training compared to typical MCI development. We will compare the outcomes between participants with MCI who receive structured cognitive training (treatment group: TG) with those who receive nonspecific computerized training activities (active controls: AC). The duration of intervention is 6 months. The focus of the study will be on individuals with amnestic MCI (single- or multi- domain). The study includes 30 MCI subjects in a treatment group (TG) and 30 matched MCI subjects in active control (AC) group. TG and AC participants will be evaluated at two time points: 1) baseline and 2) 6-month (post-training).
- Conditions
- Mild Cognitive Impairment
- Being tested
- Multi-domain cognitive training, Cross-word puzzle training
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-domain cognitive trainingBehavioural
The cognitive exercises are designed to train executive functions and memory.
Cross-word puzzle trainingBehavioural
The active control group will be asked to complete a variety of crossword puzzles using the same curriculum assigned to the TG group.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment group will receive 6 months of online, computerized, multi-domain cognitive training at home. Receives: Behavioral: Multi-domain cognitive training |
| Active Control | Active comparator | The Active Control group will receive 6 months of online, computerized cross-word puzzles at home using the same platform as for the Treatment group. Receives: Behavioral: Cross-word puzzle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive function composite score
The primary behavioral outcome is executive function composite score that combines measures of working memory, inhibition, set-shifting, and fluency
Measured: 6 months
Executive function network connectivity
The primary neuroimaging outcome is the interconnectivity of the frontal-striatal-parietal network.
Measured: 6 months
Secondary outcomes (3)
Memory function composite score
Memory function composite score that combines measures of auditory verbal learning and episodic memory
Measured: 6 months
Medial temporal network connectivity
Regional interconnectivity and centrality in medial temporal network
Measured: 6 months
White matter integrity in memory circuit
White matter integrity in posterior cingulate-medial temporal-frontal pathways
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start30 Oct 2017
- Primary completion30 Sep 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Hadi Hosseini, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883308
- Sponsor's protocol ID
- 120954
- Other IDs
- 5K25AG050759
- Status last verified
- May 2021
- First submitted
- 18 Mar 2019
- Last updated
- 5 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gozdas E, Avelar-Pereira B, Fingerhut H, Dacorro L, Jo B, Williams L, O'Hara R, Hosseini SMH. Long-term cognitive training enhances fluid cognition and brain connectivity in individuals with MCI. Transl Psychiatry. 2024 Oct 23;14(1):447. doi: 10.1038/s41398-024-03153-x.
PubMed 39443463
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Multi-domain Cognitive Training on Large-scale Structural and Functional Brain Networks in MCI
- ClinicalTrials.gov ID
- NCT03883308
- Acronym / sponsor ID
- 120954
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 20 Mar 2019 (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.
The purpose of this study is to integrate advanced computational techniques and multimodal neuroimaging methods to examine the potential effects of long-term, multi-domain, online, computerized cognitive training on large-scale structural and functional brain networks in older adults with mild cognitive impairment (MCI).
Detailed description
This multilevel study will be comprised of a placebo controlled randomized controlled trial to test the effect of long-term (6 months), multi-domain, computerized cognitive training on large-scale structural and functional brain networks in individuals with MCI (age >= 65 years). Neuroimaging and neuropsychological data before and after intervention will be evaluated within and between groups to elucidate the trajectory of neuronal network improvements associated with training compared to typical MCI development. We will compare the outcomes between participants with MCI who receive structured cognitive training (treatment group: TG) with those who receive nonspecific computerized training activities (active controls: AC). The duration of intervention is 6 months. The focus of the study will be on individuals with amnestic MCI (single- or multi- domain). The study includes 30 MCI subjects in a treatment group (TG) and 30 matched MCI subjects in active control (AC) group. TG and AC participants will be evaluated at two time points: 1) baseline and 2) 6-month (post-training).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Multi-domain cognitive trainingTreatment group will receive 6 months of online, computerized, multi-domain cognitive training at home. |
| Active Control | Active comparator | Behavioral: Cross-word puzzle trainingThe Active Control group will receive 6 months of online, computerized cross-word puzzles at home using the same platform as for the Treatment group. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Cognitive concern by subject, informant or physician
- Impairment in memory domain (delayed recall of one paragraph from Logical Memory II subscale from Wechsler memory Scale - Revised with cutoff scores of <=8, <=4 and <=2 for 16, 8-15 and 0-7 years of education)
- Essentially normal functional activities
- Mini-Mental State Examination (MMSE) scores >=24
- Stability of permitted medications (e.g. cholinesterase inhibitors, hypertension medication, etc.) for at least two months.
Key exclusion criteria (6 listed)
- Any significant neurological condition including probable dementia, Parkinson's disease, Huntington's disease, multiple sclerosis, and brain tumor, among others.
- Presence of Axis I disorder
- Current use of psychoactive medications except for the permitted medications.
- Claustrophobia
- MRI contraindication
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 |
|---|---|---|
| Multi-domain cognitive trainingThe cognitive exercises are designed to train executive functions and memory. | Behavioural | Treatment |
| Cross-word puzzle trainingThe active control group will be asked to complete a variety of crossword puzzles using the same curriculum assigned to the TG group. | Behavioural | Active Control |
Primary outcome
Executive function composite score
Time frame: 6 months
The primary behavioral outcome is executive function composite score that combines measures of working memory, inhibition, set-shifting, and fluency
Executive function network connectivity
Time frame: 6 months
The primary neuroimaging outcome is the interconnectivity of the frontal-striatal-parietal network.
3 secondary outcomes
Memory function composite score
Time frame: 6 months
Medial temporal network connectivity
Time frame: 6 months
White matter integrity in memory circuit
Time frame: 6 months
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 5 May 2021.
- Derived from this study: PubMed 39443463Gozdas E, Avelar-Pereira B, Fingerhut H, Dacorro L, Jo B, Williams L, O'Hara R, Hosseini SMH. Long-term cognitive training enhances fluid cognition and brain connectivity in individuals with MCI. Transl Psychiatry. 2024 Oct 23;14(1):447. doi: 10.1038/s41398-024-03153-x.
Related trials for Mild Cognitive Impairment
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
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-domain cognitive training and Cross-word puzzle training in people with Mild Cognitive Impairment, run by Stanford University at 1 site in United States.
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 5 inclusion and 6 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 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Executive function composite score (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03883308, which also lists 1 linked publication.
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 5 May 2021.