Mental Training for Adults With Mild Cognitive Impairment
Primary Purpose
Mild Cognitive Impairment, Aging
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness
Brain Games and Puzzles
Sponsored by

About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mindfulness, Meditation, Imaging, MRI
Eligibility Criteria
Inclusion Criteria:
- CDR (clinical dementia rating) of 0.5
- 50-90 years of age
- Able to speak, read, and understand English
- Willing to participate in a 6 month study and undergo 2 MRI scans at Mass General Hospital
- A score suggesting Mild Cognitive Impairment on the Telephone Interview for Cognitive Status (TICS)
- A Mini Mental State Exam adjusted for age and education of 24 to 30
- Stable medications for at least 30 days
- Subjects with well-controlled vascular risk factors such as treated hypertension, treated hyperlipidemia or well-controlled Type II diabetes (glucose levels < 250) will be included.
- Subjects with a history of cerebrovascular problems but have no persistent neurological deficits will be included
- Available for scheduled class times for both study courses
- Able to complete 40 minutes of homework per day during the 6-month course
- CDR (clinical dementia rating) of 0.5
Exclusion Criteria:
- CDR score other than 0.5
- Cardiovascular disease, stroke, congestive heart failure
- Has surgical aneurysm clips, neurostimulator, implanted pumps, metal fragments in eyes, cardiac pacemaker, non-removable nitroglycerin patch, non-MRI compatible cochlear implants, any other non-MRI compatible metal in body
- Has permanent bridgework in upper mouth that could interfere with MRI scan
- Active hematological, renal, pulmonary, endocrine, or hepatic disorders
- Uncontrolled high blood pressure
- Uncontrolled diabetes or insulin-treated diabetes (diabetes that is controlled with no more than one oral medication will be allowed)
- A history of neurological disease or injury, including a history of seizures or significant head trauma (i.e. extended loss of consciousness, bleeding in the brain, Parkinson's disease, stroke)
- Received treatment for cancer within the last year (skin cancer will be allowed as will any cancer more than 2 years since the last treatment)
- Diagnosis of schizophrenia, PTSD, bipolar disorder, or psychotic disorder at any point during lifetime
- Any axis I psychiatric disorder within the last 12 months
- Weighs more than 350 pounds
- Neurological or medical conditions that would interfere with study procedures or confound results, such as conditions that alter cerebral blood flow or metabolism
- Unstable medications or on medications with CNS effects including cholinesterase inhibitors, memantine, and antidepressants
- Use of psychotropic medications within 12 months prior to the study
- Daily use of any medication that alters neural metabolism or blood flow, including chronic use of benzodiazepines, potent CNS penetrant anticholinergic medications (for bladder control or allergies). These medications taken on an as-needed basis (prn) will be allowed. (Over the counter supplements such as Gingko and fish oil will be allowed)
- Any other medications as reviewed by a clinician on a case-by-case basis
- Current regular practice of meditation, yoga, tai chi, Feldenkrais, or other mind-body practice or more than 8 30-minute long mind-body sessions within the last 6 months. Significant prior mind-body experience as determined by the PI based on frequency, duration, recency, and type of practice.
- Claustrophobia
- Any other criteria that will interfere with the subject's participation as determined by study doctor
- Participation in any investigational drug study within 4 weeks of screening.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness
Brain Games and Puzzles
Arm Description
Class meeting three times a week for six months, led by a certified mindfulness meditation instructor. Includes instruction and practice on techniques such as breathing, body scan, physical sensations, and yoga.
Class meeting three times a week for six months, led by a qualified instructor. Includes teaching and practice of puzzles such as word searches, crossword puzzles, Sudoku, and KenKen.
Outcomes
Primary Outcome Measures
Recruitment feasibility
Number of subjects recruited within 6 months; determine the number of people excluded for each inclusion/exclusion criterion; assessing reasons why eligible people decide not to enroll.
Retention
Remaining in the study for the full duration of all testing time points (yes/no). Quantify the reasons for dropout
Adherence to study protocol
Number of classes attended; number of times the subject practiced prescribed activities at home; number of people who complete each test/assessment.
Secondary Outcome Measures
Full Information
NCT ID
NCT03895346
First Posted
March 26, 2019
Last Updated
September 14, 2022
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03895346
Brief Title
Mental Training for Adults With Mild Cognitive Impairment
Official Title
Mental Training for Adults With Mild Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
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
This study aims to determine the feasibility and acceptability of conducting a larger randomized clinical trial to test whether individuals with MCI can benefit from mental training programs.
Detailed Description
Half of participants will be randomized to a mindfulness group and half to a brain games and puzzles group as forms of mental training. Participants are adults with mild cognitive impairment. Participants will undergo neuropsychological testing, MRI scanning, and qualitative interviews to assess feasibility of conducting a larger randomized clinical trial in a population with mild cognitive impairment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Aging
Keywords
Mindfulness, Meditation, Imaging, MRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigator and outcomes assessors will be masked to the group assignment of participants (mindfulness or brain games and puzzles).
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness
Arm Type
Experimental
Arm Description
Class meeting three times a week for six months, led by a certified mindfulness meditation instructor. Includes instruction and practice on techniques such as breathing, body scan, physical sensations, and yoga.
Arm Title
Brain Games and Puzzles
Arm Type
Active Comparator
Arm Description
Class meeting three times a week for six months, led by a qualified instructor. Includes teaching and practice of puzzles such as word searches, crossword puzzles, Sudoku, and KenKen.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Other Intervention Name(s)
Meditation
Intervention Description
Mindfulness meditation is a technique of sustained attention and focus, involving preventing the mind from wandering from the meditative object (i.e. breath or body sensations)
Intervention Type
Behavioral
Intervention Name(s)
Brain Games and Puzzles
Intervention Description
Intervention will include the instruction and practice of puzzles such as word searches, crossword puzzles, Sudoku, and KenKen.
Primary Outcome Measure Information:
Title
Recruitment feasibility
Description
Number of subjects recruited within 6 months; determine the number of people excluded for each inclusion/exclusion criterion; assessing reasons why eligible people decide not to enroll.
Time Frame
6 months
Title
Retention
Description
Remaining in the study for the full duration of all testing time points (yes/no). Quantify the reasons for dropout
Time Frame
6 months
Title
Adherence to study protocol
Description
Number of classes attended; number of times the subject practiced prescribed activities at home; number of people who complete each test/assessment.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
CDR (clinical dementia rating) of 0.5
50-90 years of age
Able to speak, read, and understand English
Willing to participate in a 6 month study and undergo 2 MRI scans at Mass General Hospital
A score suggesting Mild Cognitive Impairment on the Telephone Interview for Cognitive Status (TICS)
A Mini Mental State Exam adjusted for age and education of 24 to 30
Stable medications for at least 30 days
Subjects with well-controlled vascular risk factors such as treated hypertension, treated hyperlipidemia or well-controlled Type II diabetes (glucose levels < 250) will be included.
Subjects with a history of cerebrovascular problems but have no persistent neurological deficits will be included
Available for scheduled class times for both study courses
Able to complete 40 minutes of homework per day during the 6-month course
CDR (clinical dementia rating) of 0.5
Exclusion Criteria:
CDR score other than 0.5
Cardiovascular disease, stroke, congestive heart failure
Has surgical aneurysm clips, neurostimulator, implanted pumps, metal fragments in eyes, cardiac pacemaker, non-removable nitroglycerin patch, non-MRI compatible cochlear implants, any other non-MRI compatible metal in body
Has permanent bridgework in upper mouth that could interfere with MRI scan
Active hematological, renal, pulmonary, endocrine, or hepatic disorders
Uncontrolled high blood pressure
Uncontrolled diabetes or insulin-treated diabetes (diabetes that is controlled with no more than one oral medication will be allowed)
A history of neurological disease or injury, including a history of seizures or significant head trauma (i.e. extended loss of consciousness, bleeding in the brain, Parkinson's disease, stroke)
Received treatment for cancer within the last year (skin cancer will be allowed as will any cancer more than 2 years since the last treatment)
Diagnosis of schizophrenia, PTSD, bipolar disorder, or psychotic disorder at any point during lifetime
Any axis I psychiatric disorder within the last 12 months
Weighs more than 350 pounds
Neurological or medical conditions that would interfere with study procedures or confound results, such as conditions that alter cerebral blood flow or metabolism
Unstable medications or on medications with CNS effects including cholinesterase inhibitors, memantine, and antidepressants
Use of psychotropic medications within 12 months prior to the study
Daily use of any medication that alters neural metabolism or blood flow, including chronic use of benzodiazepines, potent CNS penetrant anticholinergic medications (for bladder control or allergies). These medications taken on an as-needed basis (prn) will be allowed. (Over the counter supplements such as Gingko and fish oil will be allowed)
Any other medications as reviewed by a clinician on a case-by-case basis
Current regular practice of meditation, yoga, tai chi, Feldenkrais, or other mind-body practice or more than 8 30-minute long mind-body sessions within the last 6 months. Significant prior mind-body experience as determined by the PI based on frequency, duration, recency, and type of practice.
Claustrophobia
Any other criteria that will interfere with the subject's participation as determined by study doctor
Participation in any investigational drug study within 4 weeks of screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Lazar, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02119
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Mental Training for Adults With Mild Cognitive Impairment
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