Mild Cognitive Impairment Clinical Trial
Official title:
The Influence of Multi-domain Cognitive Training on Large-scale Structural and Functional Brain Networks in MCI
Verified date | May 2021 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 60 |
Est. completion date | December 1, 2020 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years to 85 Years |
Eligibility | Inclusion criteria: - 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. Exclusion criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University School of Medicine | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Executive function composite score | The primary behavioral outcome is executive function composite score that combines measures of working memory, inhibition, set-shifting, and fluency | 6 months | |
Primary | Executive function network connectivity | The primary neuroimaging outcome is the interconnectivity of the frontal-striatal-parietal network. | 6 months | |
Secondary | Memory function composite score | Memory function composite score that combines measures of auditory verbal learning and episodic memory | 6 months | |
Secondary | Medial temporal network connectivity | Regional interconnectivity and centrality in medial temporal network | 6 months | |
Secondary | White matter integrity in memory circuit | White matter integrity in posterior cingulate-medial temporal-frontal pathways | 6 months |
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