Mild Cognitive ImpairmentNCT03895346
Mental Training for Adults With Mild Cognitive Impairment
A study testing Mindfulness and Brain Games and Puzzles in people with Mild Cognitive Impairment and Aging, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Aging
- What is being tested?
- Mindfulness and Brain Games and Puzzles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02119
About this study
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment, Aging
- Being tested
- Mindfulness, Brain Games and Puzzles
- Keywords
- Mindfulness, Meditation, Imaging, MRI
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
Also called Meditation
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)
Brain Games and PuzzlesBehavioural
Intervention will include the instruction and practice of puzzles such as word searches, crossword puzzles, Sudoku, and KenKen.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | 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. Receives: Behavioral: Mindfulness |
| Brain Games and Puzzles | Active comparator | 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. Receives: Behavioral: Brain Games and Puzzles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Retention
Remaining in the study for the full duration of all testing time points (yes/no). Quantify the reasons for dropout
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start10 Apr 2019
- Primary completion30 Mar 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara W Lazar, Massachusetts General Hospital
- Investigators
- Sara Lazar, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895346
- Sponsor's protocol ID
- 2018P002574
- Status last verified
- Sep 2022
- First submitted
- 26 Mar 2019
- Last updated
- 15 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Training for Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03895346
- Acronym / sponsor ID
- 2018P002574
- Conditions
- Mild Cognitive Impairment, Aging
- Keywords
- Mindfulness, Meditation, Imaging, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: MindfulnessClass 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. |
| Brain Games and Puzzles | Active comparator | Behavioral: Brain Games and PuzzlesClass 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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindfulnessAlso: MeditationMindfulness 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) | Behavioural | Mindfulness |
| Brain Games and PuzzlesIntervention will include the instruction and practice of puzzles such as word searches, crossword puzzles, Sudoku, and KenKen. | Behavioural | Brain Games and Puzzles |
Primary outcome
Recruitment feasibility
Time frame: 6 months
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
Time frame: 6 months
Remaining in the study for the full duration of all testing time points (yes/no). Quantify the reasons for dropout
Adherence to study protocol
Time frame: 6 months
Number of classes attended; number of times the subject practiced prescribed activities at home; number of people who complete each test/assessment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Lazar, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and Brain Games and Puzzles in people with Mild Cognitive Impairment and Aging, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.