RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Adaptive Working Memory and Physical Exercise Training to Improve Brain and Mitochondrial Function in MCI

Quick Facts

Study Start:2024-01-08

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05948930

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

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

CONTACT

410 706 1036

LChang@som.umaryland.edu

Study Locations (Sites)

University of Maryland Baltimore

Baltimore, Maryland, 21201

United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-08

Study Completion Date2026-01

Study Record Updates

Study Start Date2024-01-08

Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

Mild Cognitive Impairment