Working Memory and Physical Exercise Training in Patients With Mild Cognitive Impairment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorUniversity of Maryland, Baltimore

About this trial

The prevalence of dementia will double in the next three decades in the U.S.; effective treatment or prevention for dementia is urgently needed. The current exploratory project aims to evaluate and understand how the brain and cognition may improve after a 12-week intervention that combines brain training and aerobic exercise training to improve brain function, both in those with mild cognitive impairment (some with possible prodromal Alzheimer's disease) and with healthy aging. Findings from this pilot project will guide and refine the development of a future larger clinical trial that aligns with the goals of the National Alzheimer's Plan of Action (NAPA), especially regarding "Prevent and Effectively Treat Alzheimer's Disease (AD) by 2025.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult men and women of all races and ethnicities who are 50-80 years of age will be eligible.

Only sedentary adults will be eligible (engaging in structured activity for exercise <3x/week) for Progressive aerobic exercise or Combined training

Ability to use, and accessibility to, an iPad or computer is required for the Adaptive cognitive training and Combined training.

Fluent in English.

Disqualifiers

Does not have access to a computer or internet to perform the Cogmed® training AND is unwilling to come to the lab for the training.

Unable to undergo an MRI investigation based on claustrophobia or metal foreign bodies.

Symptomatic heart disease, Coronary artery disease, congestive heart failure, uncontrolled hypertension, uncontrolled diabetes (HbA1c>10%), significant cardiovascular disorders (on EKG and graded exercise test) that would prevent the participant from the exercise training; neurologic, musculoskeletal, or other condition that limits the subject's ability to complete study physical assessments.

Estimated verbal Intelligence Quotient (IQ) below 70 (based on the Wechsler Test of Adult Reading) which would invalidate the informed consent process for the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Progressive aerobic exercise

    Behavioral

    Progressive aerobic exercise

  • Adaptive cognitive training

    Behavioral

    Adaptive cognitive training

  • Combined

    Behavioral

    Combine adaptive cognitive and progressive aerobic exercise training

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Aerobic ExerciseExperimental treatment 1 intervention
Group B: Cognitive TrainingExperimental treatment 1 intervention
Group C: Combined Cognitive and Aerobic ExerciseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Changes in Brain structure measures

Changes in brain volume measures from T1-weighted images (volumes in mm3)

Time frame
At baseline and at 4 weeks after the corresponding training program.
2

Changes in brain cortical thickness measures

Changes in brain cortical thickness measures from T1-weighted images (thickness measures in mm)

Time frame
At baseline and at 4 weeks after the corresponding training program.
3

Changes in Brain microstructure measures

Changes in brain measures of diffused tensor imaging (diffusion coefficient in mm²/s)

Time frame
At baseline and at 4 weeks after the corresponding training program.
4

Changes in Brain blood flow from Arterial spin labeling magnetic resonance imaging (ASL-MRI) in milliliters/100 g/minutes

Changes in Brain blood flow from Arterial spin labeling magnetic resonance imaging (ASL-MRI) in milliliters/ 100 g/ minutes

Time frame
At baseline and at 4 weeks after the corresponding training program.

Secondary outcomes

1

VO2peak

VO2peak will be used as the primary measure of aerobic capacity. Subjects will be asked to exercise to voluntary exhaustion during a treadmill test using a modified Bruce protocol. Oxygen (O2) consumption, carbon dioxide (CO2) production, and minute ventilation will be measured breath-by-breath using a metabolic cart and the average of the final two 20 second values of O2 consumption are VO2peak.

Time frame
At baseline and within one week after the corresponding training program.

Other outcomes

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