Mindfulness Based Stress Reduction for Adults With Mild Cognitive Impairment

Completed · Not applicable

Conditions studied: Mild Cognitive Impairment

In brief

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

Key facts

Study ID

NCT01605448

Run by

Beth Israel Deaconess Medical Center

People needed

14

Starts

2010-01-01

Expected to finish

2012-01-01

Last updated by the study team

2012-05-24

Who can join

Age: 60 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of MCI* made by a neurologist (through history, physical exam and neuropsychological testing)
• Memory complaint, corroborated by an informant
• 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)
• Normal general cognitive function
• Mini-Mental Status Exam (MMSE) score of >24 out of 30
• No/minimal impairment in activities of daily living
• 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

You may not qualify if…

• 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.

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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