Purpose

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.

Condition

Eligibility

Eligible Ages
Between 50 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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). - Ability to use, and accessibility to, an iPad or computer. - Fluent in English. - The diagnosis of MCI will first be confirmed at the screening evaluation using the clinical dementia rating (CDR) scale and the Montreal Cognitive Assessment (MoCA). We will also evaluate their ADL using instrumental activities of daily living (IADL) to ensure they have preserved independence in functional abilities despite the cognitive deficits. The primary caregivers will be interviewed (either in person or by phone) for the participants' IADL to corroborate the independent functional status.

Exclusion Criteria

  • 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, 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. - Self-reported moderate to severe substance use disorder(s) (e.g., self-reported intake >3 oz liquor, or three 4 oz glasses of wine, or three 12 oz cans of beer per day or illicit drug use). - Severe chronic or acute medical or other (non-MCI) neuropsychiatric conditions that might confound the cognitive or brain imaging measures (e.g., liver function tests >2.5 normal range or evidence for renal failure). - Body mass index >40 kg/m2.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Aerobic Exercise
Progressive aerobic exercise 3x/week for 12 weeks.
  • Behavioral: Progressive aerobic exercise
    Progressive aerobic exercise
  • Behavioral: Combined
    Combine adaptive cognitive and progressive aerobic exercise training
Experimental
Cognitive Training
Adaptive cognitive training on Cogmed 5x/week for a total of 25 sessions in 5-8 weeks.
  • Behavioral: Adaptive cognitive training
    Adaptive cognitive training
Experimental
Combined Cognitive and Aerobic Exercise
Combined progressive aerobic exercise 3x/week for 12 weeks and adaptive cognitive training on Cogmed 5x/week for a total of 25 sessions in 5-8 weeks simultaneously.
  • Behavioral: Combined
    Combine adaptive cognitive and progressive aerobic exercise training

Recruiting Locations

University of Maryland Baltimore
Baltimore, Maryland 21201
Contact:
Mahsa Mayeli, M.D., MPH
410-706-1029
mmayeli@som.umaryland.edu

More Details

Status
Recruiting
Sponsor
University of Maryland, Baltimore

Study Contact

Linda Chang, M.D., M.S.
410 706 1036
LChang@som.umaryland.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.