Mental Training for Adults With Mild Cognitive Impairment



Status:Recruiting
Conditions:Cognitive Studies, Cognitive Studies, Healthy Studies
Therapuetic Areas:Psychiatry / Psychology, Other
Healthy:No
Age Range:50 - 90
Updated:3/31/2019
Start Date:April 25, 2019
End Date:December 31, 2019
Contact:Erin Mulvihill
Email:emulvihill@mgh.harvard.edu
Phone:6176437271

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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 mindfulness
training.

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.

Inclusion Criteria:

- CDR (clinical dementia rating) of 0.5

- 50-90 years of age

- Right-handed

- 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 45-60 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.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Sara Lazar, PhD
Phone: 866-449-6779
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mi
from
Boston, MA
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