Mindful Awareness Program for the Prevention of Dementia: A Randomized Controlled Trial

Study Overview
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Brief Summary
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The objective of this study is to determine whether regular Mindful Awareness Program (MAP) may reverse cognitive impairment and/or prevent further cognitive decline among older adults. 60 elderly with mild cognitive impairment (MCI) were randomized to participate in either the MAP or the Health Education Program (HEP). Sessions will be conducted weekly for 12 weeks, and monthly for 6 months. Participants would be assessed at 3 time-points: at the start, at 3-months and at 9-months. It was hypothesized that as compared to HEP participants, MAP participants will (1) have improved functional connectivity, (2) have a decreased risk in cognitive decline and (3) report higher psychological well-being.

Detailed Description
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Participants Study participants are community-dwelling elderly. Assessments Demographic data will be collected at the start. Psychological tests for depression and anxiety and neuropsychological tests of cognitive functioning will be done at the start, at 3-months and at 9-months, the end of the study. A urine sample will be collected at the start and at the end of the study; blood, fecal and saliva samples will be collected at all three time points. Participants will also undergo a brain neuro-imaging scan at the start of the study and at the 3-months interval. Intervention Sessions This is an intervention study with a control group design. The strength of this design is its experimental nature with randomization. The control group is the health education program participants. In the Mindful Awareness Program, all 30 participants will be seen in a group format once a week for 40 minutes for 12 weeks, followed by once a month for 40 minutes for 6 months. The intervention is modelled on similar groups teaching mindfulness meditation to the elderly. The sessions will be led by an experienced instructor who has conducted pilot studies on the use of mindful awareness practice techniques with the elderly. Participants shall be required to practice these techniques at home daily and will be asked to keep a log of their practice. For the Health Education Program, all 30 participants will be seen in a group format once a week for 40 minutes for 12 weeks, followed by once a month for 40 minutes for 6 months. Each weekly session will cover a healthy living topic related to maintaining and improving cognitive function. The monthly sessions will review the topics covered with a discussion of how participants have implemented the imparted knowledge to their daily lives. The sessions will be led by an experienced instructor who has conducted similar teaching sessions to the elderly. Participants will be provided with hand-outs at each session, and there will be discussions to encourage them to practice what is being taught in their daily lives.

Official Title
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Mindful Awareness Program for the Prevention of Dementia: A Randomized Controlled Trial

Conditions
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Dementia

Intervention / Treatment
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* Behavioral: Mindful Awareness Program
* Behavioral: Health Education Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: an elderly person between the age of 60 and 85 living in the community and fulfill the operational criteria/definition of MCI: At least one age-education adjusted neuropsychological test Z score < -1.5 Do not meet DSM-IV criteria for dementia syndrome Memory / Cognitive complaint, preferably corroborated by a reliable informant Intact Activities of Daily Living. function independently do not suffer from dementia, able to travel on their own to the data collection site and participate in the MAP or HEP Exclusion Criteria: Those who do not meet the above inclusion criteria (ie. Do not have a MCI diagnosis), Those with Dementia or Normal Ageing Have a neurological condition (e.g., epilepsy, Parkinson's Disease), Have a major psychiatric condition (e.g., major depressive disorder) Suffer from a terminal illness (e.g., cancer). Have significant visual or hearing impairment, or Marked upper and lower limb motor difficulties, which may affect their ability to participate in the study. Are in another interventional study at the same time

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindful Awareness Program<br>18 sessions of mindful awareness program teaching the elderly mindful awareness practice techniques | Behavioral: Mindful Awareness Program<br>* For Mindful Awareness Program, 40-minutes weekly sessions for 12 weeks, followed by 40-minutes monthly for 6 months. The mindful awareness practice techniques to be taught to the elderly include: (1) mindfulness of the senses practice; (2) the body scan practice; (3) walking meditation practice; (4) 'movement nature meant' practice; and (5) visuo-motor limb tasks<br>* Other names: MAP;|
| Active Comparator: Health Education Program<br>18 sessions of health education program focusing on healthy living topics | Behavioral: Health Education Program<br>* For the Health Education Program, weekly sessions of 40 minutes for 12 weeks, followed by monthly sessions of 40 minutes for 6 months. Week 1: Diabetes Mellitus Week 2: Hypertension Week 3: Home Safety Week 4: Medications Week 5: Diet Week 6: Depression Week 7: Dementia Week 8: Anxiety Week 9: Sleep Week 10: Exercise Week 11: Coping with bereavement Week 12: Social support<br>* Other names: HEP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Mini-Mental State Examination (MMSE) at 3 months and 9 months | Mini-Mental State Examination (MMSE) is a brief 30-point questionnaire administered by health care professionals to screen for cognitive impairment. The score ranges from 0 to 30; the higher the score, the less impaired is the participant's cognitive function. | baseline, 3-months, 9-months | 
| Change from baseline Clinical Dementia Rating (CDR ) at 3 months and 9 months | Clinical Dementia Rating (CDR ) is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias: Memory, Orientation, Judgment & Problem Solving, Community Affairs, Home & Hobbies, and Personal Care. | baseline, 3-months, 9-months | 
| Change from baseline Rey Auditory Verbal Learning Test (RAVLT) at 3 months and 9 months | Rey Auditory Verbal Learning Test (RAVLT) evaluates declarative verbal learning and memory. | baseline, 3-months, 9-months | 
| Change from baseline Digit Span Task at 3 months and 9 months | Digit Span Task, which consists of a Digit Span Forward (DSF) and a Digit Span Backward (DSB) task is used to assess attention and verbal working memory. | baseline, 3-months, 9-months | 
| Change from baseline Colour Trails Tests (CTT) at 3 months and 9 months | Colour Trails Tests (CTT) 1 and 2 assesses sustained attention and sequencing. | baseline, 3-months, 9-months | 
| Change from baseline Block Design at 3 months and 9 months | Block Design is a subtest that is administered as part of several of the Wechsler Intelligence tests, and it primarily measures visual-spatial and organizational processing abilities, as well as non-verbal problem-solving skills. | baseline, 3-months, 9-months | 
| Change from baseline Semantic Verbal Fluency (Animals) at 3 months and 9 months | Semantic Verbal Fluency (Animals) taps lexical knowledge and semantic memory organization. | baseline, 3-months, 9-months | 
| Change from baseline fMRI scan at 3 months | Functional Magnetic Resonance Imaging (fMRI) will be employed to examine changes in functional connectivity. Images will be acquired on a 3T Siemens scanner using a standard Siemens whole head coil. All subjects will undergo the task-free fMRI scan after being instructed only to remain awake with their eyes closed. White Matter Diffiusion Tractography Imaging (DTI) will be utilized to identify anatomical connections between functionally correlated regions . The MRI Brain Scan is non-invasive and does not involve the use of Contrast; duration of each scan is approximately one hour. | baseline, 3-months | 
| Change from baseline Biomarkers: blood sample at 3 months and 9 months | 5 ml of blood will be collected using plasma tubes with indomethacin (15uM final conc) and BHT (20ul of 2mM) will be added prior to freezing (-80 Degree Celsius) to preserve the sample and prevent artifacts (at baseline, 3 months, 9 months). 3 ml of blood will be collected using tubes with no coagulant (at baseline, 3 months and 9 months). 5 ml of blood will be collected using Tempus Blood RNA tubes and will be stored in a refrigerator at approximately 4 Degree Celsius (at baseline and 9 months). Blood sample would be analysed for cytokine levels; chromosomal studies and terminal telomere restriction fragment length. | baseline, 3-months, 9-months | 
| Change from baseline Biomarkers: urine sample at 9 months | 15 ml sample of urine will be collected and frozen as quickly as possible. Urine sample would be analysed for oxidative biomarkers. | baseline, 9-months | 
| Change from baseline Biomarker - fecal sample at 3 months and 9 months | A fecal sample will also be collected in a tube with RNALater and microbeads. These can be kept at 40C till processing. Fecal sample would be analysed for bacteria. | baseline,3 months, 9 months | 
| Change from baseline Biomarker - saliva sample at 3 months and 9 months | Saliva will be collected in a test-tube by having participants continuously spit into a 50ml centrifuge tube for 5 minutes. Saliva sample would be analysed for salivary cortisol analysis, DNA extraction and sequencing for stress biomarkers (cytokines). | baseline,3 months, 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Basic Health Screen at 3 months and 9 months | the Blood pressure, Pulse rate, Height and Weight will be measured. | baseline, 3-months, 9-months | 
| Change from baseline Activities of daily Living (ADL) at 3 months and 9 months | Activities of daily Living (ADL) is a questionnaire to screen for functional assessment. | baseline, 3-months, 9-months | 
| Change from baseline Instrumental Activities of Daily Living (IADL) at 3 months and 9 months | Instrumental Activities of Daily Living (IADL) is a questionnaire to screen for functional assessment. | baseline, 3-months, 9-months | 
| Change from baseline Geriatric Depression Scale (GDS) at 3 months and 9 months | Psychological well-being will be assessed using the Geriatric Depression Scale. Subjects with high scores will not be enrolled into the study and will be informed of the scores and advised to see a doctor at a polyclinic or their family physician with a referral letter prepared for this purpose. | baseline, 3-months, 9-months | 
| Change from baseline Geriatric Anxiety Inventory (GAI) at 3 months and 9 months | Psychological well-being will be assessed using the Geriatric Anxiety Inventory (GAI). Subjects with high scores will not be enrolled into the study and will be informed of the scores and advised to see a doctor at a polyclinic or their family physician with a referral letter prepared for this purpose. | baseline, 3-months, 9-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention of dementia, Mindful awareness program, Mild cognitive impairment, Mindfulness, Elderly, Cognitive decline