Mild Cognitive Impairment (MCI)NCT06792877
Mindfulness for Cognition in Early-stage Alzheimer's Disease
A study testing Mindfulness Intervention and Waitlist then mindfulness in people with Mild Cognitive Impairment (MCI) and Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease, run by VA Boston Healthcare System at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if mindfulness meditation can improve outcomes in older adults with and without cognitive impairment. The main questions it aims to answer are: 1. How does mindfulness impact thinking and memory? 2. How does mindfulness influence brain function and structure? 3. Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease, TBI (Traumatic Brain Injury)
- What is being tested?
- Mindfulness Intervention and Waitlist then mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy older adults will show cognitive performance within 1.0 SD for age \& education adjusted norms on a neuropsychological test battery
- Mild cognitive impairment (MCI) participants will show performance on delayed recall or one more or more other cognitive domains worse than 1.5 SD for age \& education adjusted norms, an MMSE score between 25-30, and a MoCA score between 20-30.
Who cannot join
- Participants without a computer, smart phone and internet access will be excluded
- If they cannot understand the informed consent form or have moderate dementia.
- Mood disorders (e.g., PTSD, depression, anxiety) or alcohol and drug use that either interferes with day-to-day life or required hospitalization within the past 5 years
- Cerebrovascular disease
- Any medical condition whose severity could significantly impair cognition (e.g., stroke, frontotermporal dementia, Parkinson's disease) are exclusionary
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Boston Healthcare System - Jamaica Plain Campus
Boston, Massachusetts, 02130
Kathy Xie, PhD, 8573645429, ctcnbrainlab@gmail.com
Katherine W Turk, MD
About this study
Official title: Mechanisms of Mindfulness for Cognition in Early-Stage Alzheimer's Disease
The goal of this clinical trial is to learn if mindfulness meditation can improve outcomes in older adults with and without cognitive impairment. The main questions it aims to answer are:
- How does mindfulness impact thinking and memory?
- How does mindfulness influence brain function and structure?
- How does mindfulness affect daily function and quality of life?
Read more
Researchers will compare all outcomes to one other groups. In one group, individuals will participate in a mindfulness class intervention; in the other group, individuals will not engage in any active interventions immediately, but will be placed on a waitlist for the mindfulness intervention. Researchers will compare all outcomes between the groups groups to determine whether the mindfulness interventions leads to greater improvement compared to no intervention (waitlist group).
Participants will:
- Be randomly assigned to participate in the mindfulness intervention, or no immediate intervention (waitlist)
- Complete paper-and-pencil cognitive testing, surveys, computerized tasks, and neuroimaging measures (EEG and MRI) before and after the intervention
Outcomes will be assess at baseline, 2 months, 4 months and 6 months.
- Conditions
- Mild Cognitive Impairment (MCI), Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease, TBI (Traumatic Brain Injury), Aging, Healthy Elderly, Alzheimer&Amp;Amp;#39;s Dementia (AD)
- Being tested
- Mindfulness Intervention, Waitlist then mindfulness
- Keywords
- Mindfulness, Aging, Mild Cognitive Impairment (MCI), Cognition, Memory, Alzheimers Disease, Social Group
- Medical subject headings
- Cognitive Dysfunction, Brain Injuries, Traumatic, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness InterventionBehavioural
Also called Mindfulness-Based Stress Reduction, Meditation
The Mindfulness Intervention is an adapted form of Mindfulness-based stress reduction (MBSR) training virtual class that meets for 10 weeks. The class involves mindfulness training using awareness and focused attention, group discussion of the experience, and mindful movement. The Mindfulness Intervention also includes daily home practice using mindfulness recordings.
Waitlist then mindfulnessBehavioural
Participants in this arm will first wait 10 weeks and then complete a mindfulness course with outcome measures assessed at baseline, after 10 weeks wait list and then after mindfulness course.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | MBSR course of mindfulness using focused attention, body scan practice and light chair yoga. Receives: Behavioral: Mindfulness Intervention; Behavioral: Waitlist then mindfulness |
| Mindfulness Waitlist | No intervention | Individuals in the Mindfulness Waitlist group will not engage in any of the study interventions until 2 months has passed. Then they will be enrolled in the Mindfulness Intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological tests
Paper-and-pencil tests measuring attention, processing speed, and memory.
Measured: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
Performance on computerized tasks
Reaction time and accuracy on computer tasks measuring attention and memory
Measured: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
Resting state and event-related electrophysiology
Electrophysiology measured while at rest and time-locked to performance on a computerized task measuring attention and memory
Measured: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
Brain function and structure
Blood-oxygen-level-dependent (BOLD) for functional magnetic resonance imaging. Voxel-based morphometry (VBM) and diffusion tensor imaging (DTI) for structural magnetic resonance imaging.
Measured: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks))
Survey outcomes
Surveys measuring mood, social isolation, sleep, and quality of life
Measured: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start23 Jan 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Boston Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Katherine Turk, VA Boston Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792877
- Sponsor's protocol ID
- 1796795
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Mindfulness for Cognition in Early-Stage Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06792877
- Acronym / sponsor ID
- 1796795
- Conditions
- Mild Cognitive Impairment (MCI), Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease, TBI (Traumatic Brain Injury), Aging, Healthy Elderly, Alzheimer&Amp;Amp;#39;s Dementia (AD)
- Keywords
- Mindfulness, Aging, Mild Cognitive Impairment (MCI), Cognition, Memory, Alzheimers Disease, Social Group
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- VA Boston Healthcare SystemUS federal agency
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 27 Jan 2025 (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.
The goal of this clinical trial is to learn if mindfulness meditation can improve outcomes in older adults with and without cognitive impairment. The main questions it aims to answer are:
- How does mindfulness impact thinking and memory?
- How does mindfulness influence brain function and structure?
- How does mindfulness affect daily function and quality of life?
Researchers will compare all outcomes to one other groups. In one group, individuals will participate in a mindfulness class intervention; in the other group, individuals will not engage in any active interventions immediately, but will be placed on a waitlist for the mindfulness intervention. Researchers will compare all outcomes between the groups groups to determine whether the mindfulness interventions leads to greater improvement compared to no intervention (waitlist group).
Participants will:
- Be randomly assigned to participate in the mindfulness intervention, or no immediate intervention (waitlist)
- Complete paper-and-pencil cognitive testing, surveys, computerized tasks, and neuroimaging measures (EEG and MRI) before and after the intervention
Outcomes will be assess at baseline, 2 months, 4 months and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Mindfulness Intervention, Behavioral: Waitlist then mindfulnessMBSR course of mindfulness using focused attention, body scan practice and light chair yoga. |
| Mindfulness Waitlist | No intervention | –Individuals in the Mindfulness Waitlist group will not engage in any of the study interventions until 2 months has passed. Then they will be enrolled in the Mindfulness Intervention. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy older adults will show cognitive performance within 1.0 SD for age \& education adjusted norms on a neuropsychological test battery
- Mild cognitive impairment (MCI) participants will show performance on delayed recall or one more or more other cognitive domains worse than 1.5 SD for age \& education adjusted norms, an MMSE score between 25-30, and a MoCA score between 20-30.
Key exclusion criteria (5 listed)
- Participants without a computer, smart phone and internet access will be excluded
- If they cannot understand the informed consent form or have moderate dementia.
- Mood disorders (e.g., PTSD, depression, anxiety) or alcohol and drug use that either interferes with day-to-day life or required hospitalization within the past 5 years
- Cerebrovascular disease
- Any medical condition whose severity could significantly impair cognition (e.g., stroke, frontotermporal dementia, Parkinson's disease) are exclusionary
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 |
|---|---|---|
| Mindfulness InterventionAlso: Mindfulness-Based Stress Reduction, MeditationThe Mindfulness Intervention is an adapted form of Mindfulness-based stress reduction (MBSR) training virtual class that meets for 10 weeks. The class involves mindfulness training using awareness and focused attention, group discussion of the experience, and mindful movement. The Mindfulness Intervention also includes daily home practice using mindfulness recordings. | Behavioural | Mindfulness |
| Waitlist then mindfulnessParticipants in this arm will first wait 10 weeks and then complete a mindfulness course with outcome measures assessed at baseline, after 10 weeks wait list and then after mindfulness course. | Behavioural | Mindfulness |
Primary outcome
Neuropsychological tests
Time frame: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
Paper-and-pencil tests measuring attention, processing speed, and memory.
Performance on computerized tasks
Time frame: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
Reaction time and accuracy on computer tasks measuring attention and memory
Resting state and event-related electrophysiology
Time frame: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
Electrophysiology measured while at rest and time-locked to performance on a computerized task measuring attention and memory
Brain function and structure
Time frame: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks))
Blood-oxygen-level-dependent (BOLD) for functional magnetic resonance imaging. Voxel-based morphometry (VBM) and diffusion tensor imaging (DTI) for structural magnetic resonance imaging.
Survey outcomes
Time frame: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks))
Surveys measuring mood, social isolation, sleep, and quality of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Intervention and Waitlist then mindfulness in people with Mild Cognitive Impairment (MCI) and Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease, run by VA Boston Healthcare System 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine W Turk, MD (8573645429, ctcnbrainlab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological tests (time frame: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)). The study lists 5 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 27 Jan 2025.