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

NCT ID: NCT05948930

Last Updated: 2025-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-08

Study Completion Date

2026-08-07

Brief Summary

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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.

Detailed Description

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Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Aerobic Exercise

Progressive aerobic exercise 3x/week for 12 weeks.

Group Type EXPERIMENTAL

Progressive aerobic exercise

Intervention Type BEHAVIORAL

Progressive aerobic exercise

Cognitive Training

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

Group Type EXPERIMENTAL

Adaptive cognitive training

Intervention Type BEHAVIORAL

Adaptive cognitive training

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.

Group Type EXPERIMENTAL

Combined

Intervention Type BEHAVIORAL

Combine adaptive cognitive and progressive aerobic exercise training

Interventions

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Progressive aerobic exercise

Progressive aerobic exercise

Intervention Type BEHAVIORAL

Adaptive cognitive training

Adaptive cognitive training

Intervention Type BEHAVIORAL

Combined

Combine adaptive cognitive and progressive aerobic exercise training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Linda Chang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Maryland Baltimore

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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

Role: CONTACT

410 706 1036

Facility Contacts

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Huajun Liang, MBBS, PhD

Role: primary

410-706-1031

References

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Chacko BK, Kramer PA, Ravi S, Benavides GA, Mitchell T, Dranka BP, Ferrick D, Singal AK, Ballinger SW, Bailey SM, Hardy RW, Zhang J, Zhi D, Darley-Usmar VM. The Bioenergetic Health Index: a new concept in mitochondrial translational research. Clin Sci (Lond). 2014 Sep;127(6):367-73. doi: 10.1042/CS20140101.

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Vidorreta M, Wang Z, Chang YV, Wolk DA, Fernandez-Seara MA, Detre JA. Whole-brain background-suppressed pCASL MRI with 1D-accelerated 3D RARE Stack-Of-Spirals readout. PLoS One. 2017 Aug 24;12(8):e0183762. doi: 10.1371/journal.pone.0183762. eCollection 2017.

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Dolui S, Vidorreta M, Wang Z, Nasrallah IM, Alavi A, Wolk DA, Detre JA. Comparison of PASL, PCASL, and background-suppressed 3D PCASL in mild cognitive impairment. Hum Brain Mapp. 2017 Oct;38(10):5260-5273. doi: 10.1002/hbm.23732. Epub 2017 Jul 24.

Reference Type BACKGROUND
PMID: 28737289 (View on PubMed)

Hol HR, Flak MM, Chang L, Lohaugen GCC, Bjuland KJ, Rimol LM, Engvig A, Skranes J, Ernst T, Madsen BO, Hernes SS. Cortical Thickness Changes After Computerized Working Memory Training in Patients With Mild Cognitive Impairment. Front Aging Neurosci. 2022 Apr 4;14:796110. doi: 10.3389/fnagi.2022.796110. eCollection 2022.

Reference Type BACKGROUND
PMID: 35444526 (View on PubMed)

Panee J, Gerschenson M, Chang L. Associations Between Microbiota, Mitochondrial Function, and Cognition in Chronic Marijuana Users. J Neuroimmune Pharmacol. 2018 Mar;13(1):113-122. doi: 10.1007/s11481-017-9767-0. Epub 2017 Nov 4.

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PMID: 29101632 (View on PubMed)

Tyrrell DJ, Bharadwaj MS, Jorgensen MJ, Register TC, Shively C, Andrews RN, Neth B, Keene CD, Mintz A, Craft S, Molina AJA. Blood-Based Bioenergetic Profiling Reflects Differences in Brain Bioenergetics and Metabolism. Oxid Med Cell Longev. 2017;2017:7317251. doi: 10.1155/2017/7317251. Epub 2017 Oct 2.

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PMID: 29098063 (View on PubMed)

Chang L, Holt JL, Yakupov R, Jiang CS, Ernst T. Lower cognitive reserve in the aging human immunodeficiency virus-infected brain. Neurobiol Aging. 2013 Apr;34(4):1240-53. doi: 10.1016/j.neurobiolaging.2012.10.012. Epub 2012 Nov 15.

Reference Type BACKGROUND
PMID: 23158761 (View on PubMed)

Chang L, Yakupov R, Cloak C, Ernst T. Marijuana use is associated with a reorganized visual-attention network and cerebellar hypoactivation. Brain. 2006 May;129(Pt 5):1096-112. doi: 10.1093/brain/awl064. Epub 2006 Apr 3.

Reference Type BACKGROUND
PMID: 16585053 (View on PubMed)

Tomasi D, Caparelli EC, Chang L, Ernst T. fMRI-acoustic noise alters brain activation during working memory tasks. Neuroimage. 2005 Aug 15;27(2):377-86. doi: 10.1016/j.neuroimage.2005.04.010.

Reference Type BACKGROUND
PMID: 15893942 (View on PubMed)

Tomasi D, Ernst T, Caparelli EC, Chang L. Practice-induced changes of brain function during visual attention: a parametric fMRI study at 4 Tesla. Neuroimage. 2004 Dec;23(4):1414-21. doi: 10.1016/j.neuroimage.2004.07.065.

Reference Type BACKGROUND
PMID: 15589105 (View on PubMed)

Ernst T, Chang L, Arnold S. Increased glial metabolites predict increased working memory network activation in HIV brain injury. Neuroimage. 2003 Aug;19(4):1686-93. doi: 10.1016/s1053-8119(03)00232-5.

Reference Type BACKGROUND
PMID: 12948723 (View on PubMed)

Ernst T, Chang L, Jovicich J, Ames N, Arnold S. Abnormal brain activation on functional MRI in cognitively asymptomatic HIV patients. Neurology. 2002 Nov 12;59(9):1343-9. doi: 10.1212/01.wnl.0000031811.45569.b0.

Reference Type BACKGROUND
PMID: 12427881 (View on PubMed)

Chang L, Lohaugen GC, Douet V, Miller EN, Skranes J, Ernst T. Neural correlates of working memory training in HIV patients: study protocol for a randomized controlled trial. Trials. 2016 Feb 2;17:62. doi: 10.1186/s13063-016-1160-4.

Reference Type BACKGROUND
PMID: 26833223 (View on PubMed)

Flak MM, Hernes SS, Chang L, Ernst T, Douet V, Skranes J, Lohaugen GC. The Memory Aid study: protocol for a randomized controlled clinical trial evaluating the effect of computer-based working memory training in elderly patients with mild cognitive impairment (MCI). Trials. 2014 May 3;15:156. doi: 10.1186/1745-6215-15-156.

Reference Type BACKGROUND
PMID: 24886034 (View on PubMed)

Chang L, Lohaugen GC, Andres T, Jiang CS, Douet V, Tanizaki N, Walker C, Castillo D, Lim A, Skranes J, Otoshi C, Miller EN, Ernst TM. Adaptive working memory training improved brain function in human immunodeficiency virus-seropositive patients. Ann Neurol. 2017 Jan;81(1):17-34. doi: 10.1002/ana.24805. Epub 2016 Dec 28.

Reference Type BACKGROUND
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Brehmer Y, Westerberg H, Backman L. Working-memory training in younger and older adults: training gains, transfer, and maintenance. Front Hum Neurosci. 2012 Mar 27;6:63. doi: 10.3389/fnhum.2012.00063. eCollection 2012.

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Kramer AF, Erickson KI. Capitalizing on cortical plasticity: influence of physical activity on cognition and brain function. Trends Cogn Sci. 2007 Aug;11(8):342-8. doi: 10.1016/j.tics.2007.06.009. Epub 2007 Jul 12.

Reference Type BACKGROUND
PMID: 17629545 (View on PubMed)

Other Identifiers

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HP-00105789

Identifier Type: -

Identifier Source: org_study_id

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