Clinical trial NCT03883308: The Influence of Multi-domain Cognitive Training on Large-scale Structural and Functional Brain Networks in MCI
Official title: The Influence of Multi-domain Cognitive Training on Large-scale Structural and Functional Brain Networks in MCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-03-20
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 (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).

Eligibility criteria: 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.

Primary outcomes:
measure: Executive function composite score
timeFrame: 6 months
measure: Executive function network connectivity
timeFrame: 6 months
Secondary outcomes:
measure: Memory function composite score
timeFrame: 6 months
measure: Medial temporal network connectivity
timeFrame: 6 months
measure: White matter integrity in memory circuit
timeFrame: 6 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
References: