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

Dementia Clinical Trial

— MAPRCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02286791
• Other study ID #: B-14-110
• Status: Completed
• Phase: N/A
• First received: November 3, 2014
• Last updated: August 16, 2015
• Start date: September 2014
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

1. an elderly person between the age of 60 and 85 living in the community and fulfill the operational criteria/definition of MCI:

1. At least one age-education adjusted neuropsychological test Z score < -1.5

2. Do not meet DSM-IV criteria for dementia syndrome

3. Memory / Cognitive complaint, preferably corroborated by a reliable informant

4. Intact Activities of Daily Living.

2. function independently

3. do not suffer from dementia,

4. able to travel on their own to the data collection site and participate in the MAP or HEP

Exclusion Criteria:

1. Those who do not meet the above inclusion criteria (ie. Do not have a MCI diagnosis),

2. Those with Dementia or Normal Ageing

3. Have a neurological condition (e.g., epilepsy, Parkinson's Disease),

4. Have a major psychiatric condition (e.g., major depressive disorder)

5. Suffer from a terminal illness (e.g., cancer).

6. Have significant visual or hearing impairment, or

7. Marked upper and lower limb motor difficulties, which may affect their ability to participate in the study.

8. Are in another interventional study at the same time

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• Mindful Awareness Program
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
• Health Education Program
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

Locations

Country	Name	City	State
Singapore	Training and Research Academy	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (15)

Ardila, A., Ostrosky-Solís, F, & Bernal,B. (2006). Cognitive testing toward the future: The example of Semantic Verbal Fluency (ANIMALS), International Journal of Psychology, 41(5), 324-332

Conway AR, Kane MJ, Bunting MF, Hambrick DZ, Wilhelm O, Engle RW. Working memory span tasks: A methodological review and user's guide. Psychon Bull Rev. 2005 Oct;12(5):769-86. Review. — View Citation

Davidson RJ, Kabat-Zinn J, Schumacher J, Rosenkranz M, Muller D, Santorelli SF, Urbanowski F, Harrington A, Bonus K, Sheridan JF. Alterations in brain and immune function produced by mindfulness meditation. Psychosom Med. 2003 Jul-Aug;65(4):564-70. — View Citation

Dusek JA, Otu HH, Wohlhueter AL, Bhasin M, Zerbini LF, Joseph MG, Benson H, Libermann TA. Genomic counter-stress changes induced by the relaxation response. PLoS One. 2008 Jul 2;3(7):e2576. doi: 10.1371/journal.pone.0002576. — View Citation

Feng L, Chong MS, Lim WS, Ng TP. The Modified Mini-Mental State Examination test: normative data for Singapore Chinese older adults and its performance in detecting early cognitive impairment. Singapore Med J. 2012 Jul;53(7):458-62. — View Citation

Gard T, Hölzel BK, Lazar SW. The potential effects of meditation on age-related cognitive decline: a systematic review. Ann N Y Acad Sci. 2014 Jan;1307:89-103. doi: 10.1111/nyas.12348. Review. — View Citation

Huang L, Jia J, Liu R. Decreased serum levels of the angiogenic factors VEGF and TGF-ß1 in Alzheimer's disease and amnestic mild cognitive impairment. Neurosci Lett. 2013 Aug 29;550:60-3. doi: 10.1016/j.neulet.2013.06.031. Epub 2013 Jul 1. — View Citation

Lee TM, Chan CC. Are trail making and color trails tests of equivalent constructs? J Clin Exp Neuropsychol. 2000 Aug;22(4):529-34. — View Citation

Mcbee, L. (2008) Mindfulness-based elder care. New York: Springer.

Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4. — View Citation

Movérare-Skrtic S, Johansson P, Mattsson N, Hansson O, Wallin A, Johansson JO, Zetterberg H, Blennow K, Svensson J. Leukocyte telomere length (LTL) is reduced in stable mild cognitive impairment but low LTL is not associated with conversion to Alzheimer's disease: a pilot study. Exp Gerontol. 2012 Feb;47(2):179-82. doi: 10.1016/j.exger.2011.12.005. Epub 2011 Dec 22. — View Citation

Rapgay L, Bystrisky A. Classical mindfulness: an introduction to its theory and practice for clinical application. Ann N Y Acad Sci. 2009 Aug;1172:148-62. doi: 10.1111/j.1749-6632.2009.04405.x. — View Citation

Roberts RO, Geda YE, Knopman DS, Boeve BF, Christianson TJ, Pankratz VS, Kullo IJ, Tangalos EG, Ivnik RJ, Petersen RC. Association of C-reactive protein with mild cognitive impairment. Alzheimers Dement. 2009 Sep;5(5):398-405. doi: 10.1016/j.jalz.2009.01.025. — View Citation

Schmidt, M. (1996). Rey auditory verbal learning test: A handbook. Los Angeles: Western Psychological Services.

Wells RE, Yeh GY, Kerr CE, Wolkin J, Davis RB, Tan Y, Spaeth R, Wall RB, Walsh J, Kaptchuk TJ, Press D, Phillips RS, Kong J. Meditation's impact on default mode network and hippocampus in mild cognitive impairment: a pilot study. Neurosci Lett. 2013 Nov 27;556:15-9. doi: 10.1016/j.neulet.2013.10.001. Epub 2013 Oct 10. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic questionnaire		Baseline	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No