Mild Cognitive Impairment
Conditions
Keywords
Alzheimer's disease, exercise, cognitive training, imaging
Brief summary
This multi-site clinical trial occurs at the University of Minnesota and University of Rochester. It tests the efficacy and additive/synergistic effects of an ACT intervention on cognition and relevant mechanisms (aerobic fitness, Alzheimer's disease \[AD\] signature cortical thickness, and default mode network \[DMN\]) in older adults with amnestic MCI (aMCI).
Detailed description
Because almost all drug trials for Alzheimer's disease (AD) have failed, developing non-pharmacological interventions with strong potential to prevent or delay the onset of AD in high-risk populations (e.g., those with mild cognitive impairment \[MCI\]) is critically important. Aerobic exercise and cognitive training are 2 promising interventions for preventing AD. Aerobic exercise increases aerobic fitness, which in turn improves brain structure and function, while cognitive training improves selective neural function intensively. Hence, combined Aerobic exercise and Cognitive Training (ACT) may very well have an additive or synergistic effect on cognition by complementary strengthening of different neural functions. Few studies have tested ACT's effects, and those studies have reported discrepant findings, largely due to varying ACT programs. The purpose of this single-blinded, 2×2 factorial Phase II randomized controlled trial (RCT) is to test the efficacy and additive/synergistic effects of a 6-month combined cycling and speed of processing (SOP) training intervention on cognition and relevant mechanisms (aerobic fitness, AD signature cortical thickness, and functional connectivity in the default mode network \[DMN\]) in older adults with amnestic MCI (aMCI).
Interventions
BEHAVIORALAerobic & Cognitive Training (ACT)
ACT stands for combined aerobic exercise and cognitive training.
BEHAVIORALCycling Only
Cycling on a recumbent stationary cycle
BEHAVIORALCognitive Training Only
Engage in cognitive training on a computer
BEHAVIORALStretching and Mental Stimulating Activities
Stretching exercises and mental stimulating activities on a computer
Sponsors
University of Rochester
Mayo Clinic
University of St Thomas
University of Minnesota
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A clinical diagnosis of MCI * Community-dwelling * Age 65 years and older * English-speaking * Adequate visual acuity * Verified exercise safety by medical provider * Stable on drugs affecting cognitive and psychological status * Verified MRI safety * Capacity to consent
Exclusion criteria
* Geriatric Depression Scale \< 5 * Resting heart rate (HR) ≤50 due to arrhythmia or ≥100 beats/min * Neurological (e.g., dementia, head trauma), psychiatric (e.g., bipolar, schizophrenia, or depression), or substance dependency (alcohol or chemical dependency) in the past 5 years that are the main contributor to MCI * Contraindications to exercise, e.g. unstable angina, recent surgery * New symptoms or diseases that have not been evaluated by a health care provider * Current enrollment in another intervention study related to cognitive improvement (reduce confounding effects on outcomes) * Abnormal MRI findings
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Executive function | Change from baseline to 3, 6, 12, and 18 months | EXAMINER |
| Episodic memory | Change from baseline to 3, 6, 12, and 18 months | RAVLT and BVMTR |
| AD-signature cortical thickness | Change from baseline to 6, 12, and 18 months | Magnetic Resonance Imaging (MRI) |
| Functional connectivity in DMN | Change from baseline to 6, 12, and 18 months | Functional MRI for Default Mode Network |
| Aerobic fitness | Change from baseline to 3, 6, 12, and 18 months | VO2peak from symptom-limited peak cycle-ergometer test, and 10-m Incremental Shuttle Walk Test |
| Conversion to Alzheimer's disease | Change from baseline to 6, 12, and 18 months | Clinical adjudication of Alzheimer's disease dementia |
Countries
United States
Outcome results
None listed