Clinical trial NCT01605448: Mindfulness Based Stress Reduction for Adults With Mild Cognitive Impairment
Official title: Mindfulness Based Stress Reduction for Adults With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Alzheimer's disease
Meditation
Default Mode Network
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2012-05-24
Enrollment: 14
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators are investigating the benefits of a mind/body intervention, Mindfulness Based Stress Reduction, for adults with Mild Cognitive Impairment.

Detailed description: We propose a prospective, randomized controlled pilot trial assessing the feasibility and safety of a study investigating mindfulness based stress reduction (MBSR) as an intervention in adults with Mild Cognitive Impairment (MCI). We are assessing safety and feasibility of this intervention, as well as using neuroimaging (fMRI) to assess improved connections in the default mode network. We will also be assessing the impact of this intervention on cognitive function and measures of well-being.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of MCI\* made by a neurologist (through history, physical exam and neuropsychological testing)

  1. Memory complaint, corroborated by an informant
  2. Abnormal memory function documented by memory testing \<1.5 standard deviation below normative controls (assessed with the Wechsler Memory scale IV\[114\], Logical Memory subtest, or an equivalent test)
  3. Normal general cognitive function
  4. Mini-Mental Status Exam (MMSE) score of \>24 out of 30
  5. No/minimal impairment in activities of daily living
  6. Not sufficiently impaired, cognitively or functionally, to meet the National Institute of Neurological and Communicative Disease and Stroke/Alzheimer's Disease and Related Disorders Association criteria for AD
* 60-90 yo
* Clinical Dementia Rating (CDR total score of 0.5, with at least 0.5 on memory subscale
* No history of significant cerebrovascular disease based on Modified Hachinski score ≤ 4
* Hamilton Depression Rating Scale score ≤12 (to rule out depression as a contributing cause of cognitive decline)
* Able and willing to attend weekly sessions and willing to participate in daily mindfulness assignments, up to 45 min/day
* Agreeable to participate and to be randomized to either group
* Fluent in English (since the treatment groups will be run in English)
* Adequate visual and auditory acuity to allow neuropsychological testing
* Good general health with no additional diseases expected to interfere with the study
* MRI/CT scan within 24 months without indication of infection, infarction, or focal lesions.
* Family member/close friend ("informant") able to corroborate participant's history of memory loss
* Participants may take stable doses (stable for at least 4 weeks prior to screening) of certain medications including:

  * Antidepressants (except those with significant anticholinergic side effects such as tricyclic antidepressants). Patients cannot be currently depressed and or have a history of major depression within the past 2 years
  * Cholinesterase inhibitors and memantine

Exclusion Criteria:

* Actively practicing meditation and/or yoga or have taken a meditation/yoga class in the last 6 months
* Any major systemic illness or unstable medical condition which could lead to difficulty complying with the protocol, including the diagnosis of major depression
* On psychoactive medications (antidepressants with anticholinergic effects, ie. tricyclic antidepressants, neuroleptics, chronic anxiolytics, sedative hypnotics, other anticholinergics); participants may take stable doses (stable for at least 6 months) of low doses of psychoactive medicines (i.e. ≤ 1mg klonipin/day or ≤25mg Benadryl/day)
* Psychotic features, agitation, or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol
* History of alcohol or substance abuse or dependence within the past 2 years
* Any history of brain lesions or major head trauma
* Participant unable/unwilling to follow the protocol or return for follow-up
* Investigational agents prohibited at entry and for the duration of the trial
* Participation in other clinical studies involving neuropsychological measures being collected more than one time per year
* MRI exclusions: presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body.

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 8 weeks
measure: Feasibility: 85% completion
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in fMRI Resting state
timeFrame: Change from baseline to 8 weeks
measure: Change in Cognition
timeFrame: Change from baseline to 8 weeks
measure: Change in Measures of "well-being"
timeFrame: Change from baseline to 8 weeks
measure: Qualitative Improvements
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References: