Mild Cognitive Impairment
Conditions
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).
Interventions
BEHAVIORALMulti-domain cognitive training
The cognitive exercises are designed to train executive functions and memory.
BEHAVIORALCross-word puzzle training
The active control group will be asked to complete a variety of crossword puzzles using the same curriculum assigned to the TG group.
Sponsors
National Institute on Aging (NIA)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Executive function composite score | 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 | 6 months | The primary neuroimaging outcome is the interconnectivity of the frontal-striatal-parietal network. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Memory function composite score | 6 months | Memory function composite score that combines measures of auditory verbal learning and episodic memory |
| Medial temporal network connectivity | 6 months | Regional interconnectivity and centrality in medial temporal network |
| White matter integrity in memory circuit | 6 months | White matter integrity in posterior cingulate-medial temporal-frontal pathways |
Countries
United States
Outcome results
None listed