Recruiting

Physical Exercise

Sponsor:

University of Maryland, Baltimore

Code:

NCT05948930

Conditions

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Progressive aerobic exercise

Adaptive cognitive training

Combined

Study Details

Brief 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.

Conditions

Mild Cognitive Impairment

Study ID

NCT05948930

Start date

Jan 8, 2024

Status verified date

May, 2026

Completion date

Aug 7, 2027

Anticipated

Primary completion date

Dec 16, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

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) 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.
  • 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, 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.
  • 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

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Aerobic Exercise

Progressive aerobic exercise 3x/week for 12 weeks.

experimental: Cognitive Training

Adaptive cognitive training on Cogmed 5x/week for a total of 25 sessions in 5-8 weeks.

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.

Interventions

Progressive aerobic exercise

Progressive aerobic exercise

Adaptive cognitive training

Adaptive cognitive training

Combined

Combine adaptive cognitive and progressive aerobic exercise training

Primary outcome measure

  • Changes in Brain structure measures [ Time Frame: At baseline and at 4 weeks after the corresponding training program. ]
  • Changes in brain cortical thickness measures [ Time Frame: At baseline and at 4 weeks after the corresponding training program. ]
  • Changes in Brain microstructure measures [ Time Frame: At baseline and at 4 weeks after the corresponding training program. ]
  • 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. ]
  • Changes in Brain Activation on functional MRI [ Time Frame: At baseline and at 4 weeks after the corresponding training program. ]
  • Changes in cognitive performance, emotions, and motor function based on NIH toolbox [ Time Frame: At baseline and at 4 weeks after the corresponding training program. ]
  • Changes in executive function using the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) [ Time Frame: At baseline and at 4 weeks after the corresponding training program. ]
  • Changes in Blood Bioenergetic Markers [ Time Frame: At baseline and at 4 weeks after the corresponding training program. ]

Central Contacts and Locations

Central contacts

Linda Chang, M.D., M.S.

410 706 1036LChang@som.umaryland.edu

Locations

University of Maryland Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Huajun Liang, MBBS, PhD

410-706-1031huajun.liang@som.umaryland.edu

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

May 12, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-05-12.