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

Last updated: April 8, 2025
Sponsor: University of Maryland, Baltimore
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dementia

Mental Disability

Mild Cognitive Impairment

Treatment

Progressive aerobic exercise

Combined

Adaptive cognitive training

Clinical Study ID

NCT05948930
HP-00105789
  • Ages 50-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Inclusion

Inclusion Criteria:

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

  • 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 theAdaptive cognitive training and Combined training.

  • Fluent in English.

  • The diagnosis of MCI will first be confirmed at the screening evaluation using theclinical 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 thecognitive deficits. The primary caregivers will be interviewed (either in person orby phone) for the participants' IADL to corroborate the independent functionalstatus.

Exclusion

Exclusion Criteria:

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

  • Unable to undergo an MRI investigation based on claustrophobia or metal foreignbodies.

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

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

  • Self-reported moderate to severe substance use disorder(s) (e.g., self-reportedintake >3 oz liquor, or three 4 oz glasses of wine, or three 12 oz cans of beer perday or illicit drug use).

  • Severe chronic or acute medical or other (non-MCI) neuropsychiatric conditions thatmight 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

Total Participants: 90
Treatment Group(s): 3
Primary Treatment: Progressive aerobic exercise
Phase:
Study Start date:
January 08, 2024
Estimated Completion Date:
August 07, 2026

Connect with a study center

  • University of Maryland Baltimore

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

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