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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Progressive aerobic exercise
  Progressive aerobic exercise
• Поведенческое Adaptive cognitive training
  Adaptive cognitive training
• Поведенческое Combined
  Combine adaptive cognitive and progressive aerobic exercise training

Первичные конечные точки

• Changes in Brain structure measures [Срок оценки: At baseline and at 4 weeks after the corresponding training program.]
• Changes in brain cortical thickness measures [Срок оценки: At baseline and at 4 weeks after the corresponding training program.]
• Changes in Brain microstructure measures [Срок оценки: 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 [Срок оценки: At baseline and at 4 weeks after the corresponding training program.]
• Changes in Brain Activation on functional MRI [Срок оценки: At baseline and at 4 weeks after the corresponding training program.]
• Changes in cognitive performance, emotions, and motor function based on NIH toolbox [Срок оценки: 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) [Срок оценки: At baseline and at 4 weeks after the corresponding training program.]
• Changes in Blood Bioenergetic Markers [Срок оценки: At baseline and at 4 weeks after the corresponding training program.]

Вторичные конечные точки (1)

• VO2peak [Срок оценки: At baseline and within one week after the corresponding training program.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Maryland Baltimore — Baltimore

Публикации

• 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. PMID 24895057
• 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. PMID 28837640
• 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. PMID 28737289
• 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. PMID 35444526
• 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. PMID 29101632
• 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. PMID 29098063
• 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. PMID 23158761
• 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. PMID 16585053

Идентификаторы

NCT: NCT05948930 · HP-00105789

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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