Mental Training for Adults With Mild Cognitive Impairment

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.

Study Overview

• Status: Completed
• Conditions: Aging; Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Mindfulness; Behavioral: Brain Games and Puzzles

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02119
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mindfulness; 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.	Behavioral: Mindfulness; 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); Other Names: Meditation
ACTIVE_COMPARATOR: Brain Games and Puzzles; 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.	Behavioral: Brain Games and Puzzles; Intervention will include the instruction and practice of puzzles such as word searches, crossword puzzles, Sudoku, and KenKen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
Retention	Remaining in the study for the full duration of all testing time points (yes/no). Quantify the reasons for dropout	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 10, 2019
• Primary Completion (ACTUAL): March 30, 2020
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (ACTUAL): March 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: MRI; Imaging; Mindfulness; Meditation
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2018P002574

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No