Clinical trial NCT03895346: Mental Training for Adults With Mild Cognitive Impairment
Official title: Mental Training for Adults With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Aging
Keywords: Mindfulness
Meditation
Imaging
MRI
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-03-29
Enrollment: 22
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Recruitment feasibility
timeFrame: 6 months
measure: Retention
timeFrame: 6 months
measure: Adherence to study protocol
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sara Lazar, PhD
role: PRINCIPAL_INVESTIGATOR
References: