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

Primary Purpose

Mild Cognitive Impairment

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Progressive aerobic exercise
Adaptive cognitive training
Combined
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mild Cognitive Impairment

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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). Ability to use, and accessibility to, an iPad or computer. Fluent in English. The diagnosis of MCI will first be confirmed at the screening evaluation using the clinical dementia rating (CDR) scale and the 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 a MRI investigation based on claustrophobia or metal foreign bodies. Symptomatic heart disease, CAD, CHF, uncontrolled hypertension, 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 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.

Sites / Locations

  • University of Maryland Baltimore

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Aerobic Exercise

Cognitive Training

Combined Cognitive and Aerobic Exercise

Arm Description

Progressive aerobic exercise 3x/week for 12 weeks.

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

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.

Outcomes

Primary Outcome Measures

Changes in Brain imaging measures
Changes in brain imaging measures from morphometry (T1-weighted and diffused tensor imaging), relative cerebral blood flow (from Arterial spin labeling MR perfusion, ASL), and BOLD signal from fMRI.
Changes in cognitive performance, emotions, and motor function based on NIH toolbox
Changes in cognitive performance, emotions, and motor function scores measured by the NIH Toolbox®
Changes in executive function using the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)
Changes in executive function using the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)
Changes in Blood Bioenergetic Markers
Platelet mitochondrial respiration (OCR) and extracellular acidification rates (ECAR) will be evaluated to assess bioenergetic profiles in platelets isolated from whole blood of fasted participants. OCR will be measured using a Seahorse XFe96 as the high throughput platform. Measurements of OCR/ECAR will be performed with the following modifications. Platelets will be isolated from whole blood with a Beckman Allegra X-30R centrifuge. Platelets will be counted using a Nexcelom Bioscience Cellometer (Lawrence, MA) using calcein AM dye to enable seeding of 10,000,000 platelets per well.

Secondary Outcome Measures

VO2peak
VO2peak will be used as the primary measure of aerobic capacity. Subjects will be asked to exercise to voluntary exhaustion during a treadmill test using a modified Bruce protocol. Oxygen (O2) consumption, carbon dioxide (CO2) production, and minute ventilation will be measured breath-by-breath using a metabolic cart and the average of the final two 20 second values of O2 consumption are VO2peak.

Full Information

First Posted
July 3, 2023
Last Updated
July 12, 2023
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT05948930
Brief Title
Working Memory and Physical Exercise Training in Patients With Mild Cognitive Impairment
Official Title
Adaptive Working Memory and Physical Exercise Training to Improve Brain and Mitochondrial Function in MCI
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercise
Arm Type
Experimental
Arm Description
Progressive aerobic exercise 3x/week for 12 weeks.
Arm Title
Cognitive Training
Arm Type
Experimental
Arm Description
Adaptive cognitive training on Cogmed 5x/week for a total of 25 sessions in 5-8 weeks.
Arm Title
Combined Cognitive and Aerobic Exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Progressive aerobic exercise
Intervention Description
Progressive aerobic exercise
Intervention Type
Behavioral
Intervention Name(s)
Adaptive cognitive training
Intervention Description
Adaptive cognitive training
Intervention Type
Behavioral
Intervention Name(s)
Combined
Intervention Description
Combine adaptive cognitive and progressive aerobic exercise training
Primary Outcome Measure Information:
Title
Changes in Brain imaging measures
Description
Changes in brain imaging measures from morphometry (T1-weighted and diffused tensor imaging), relative cerebral blood flow (from Arterial spin labeling MR perfusion, ASL), and BOLD signal from fMRI.
Time Frame
At baseline and at 4 weeks after the corresponding training program.
Title
Changes in cognitive performance, emotions, and motor function based on NIH toolbox
Description
Changes in cognitive performance, emotions, and motor function scores measured by the NIH Toolbox®
Time Frame
At baseline and at 4 weeks after the corresponding training program.
Title
Changes in executive function using the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)
Description
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.
Title
Changes in Blood Bioenergetic Markers
Description
Platelet mitochondrial respiration (OCR) and extracellular acidification rates (ECAR) will be evaluated to assess bioenergetic profiles in platelets isolated from whole blood of fasted participants. OCR will be measured using a Seahorse XFe96 as the high throughput platform. Measurements of OCR/ECAR will be performed with the following modifications. Platelets will be isolated from whole blood with a Beckman Allegra X-30R centrifuge. Platelets will be counted using a Nexcelom Bioscience Cellometer (Lawrence, MA) using calcein AM dye to enable seeding of 10,000,000 platelets per well.
Time Frame
At baseline and at 4 weeks after the corresponding training program.
Secondary Outcome Measure Information:
Title
VO2peak
Description
VO2peak will be used as the primary measure of aerobic capacity. Subjects will be asked to exercise to voluntary exhaustion during a treadmill test using a modified Bruce protocol. Oxygen (O2) consumption, carbon dioxide (CO2) production, and minute ventilation will be measured breath-by-breath using a metabolic cart and the average of the final two 20 second values of O2 consumption are VO2peak.
Time Frame
At baseline and within one week after the corresponding training program.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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). Ability to use, and accessibility to, an iPad or computer. Fluent in English. The diagnosis of MCI will first be confirmed at the screening evaluation using the clinical dementia rating (CDR) scale and the 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 a MRI investigation based on claustrophobia or metal foreign bodies. Symptomatic heart disease, CAD, CHF, uncontrolled hypertension, 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Chang, M.D., M.S.
Phone
410 706 1036
Email
LChang@som.umaryland.edu
Facility Information:
Facility Name
University of Maryland Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahsa Mayeli, M.D., MPH
Phone
410-706-1029
Email
mmayeli@som.umaryland.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Working Memory and Physical Exercise Training in Patients With Mild Cognitive Impairment

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