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

NCT02286791 | Completed

• 1 other identifier: B-14-110
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dementia

Keywords

Prevention of dementia; Mindful awareness program; Mild cognitive impairment; Mindfulness; Elderly; Cognitive decline

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (5)

• Change from baseline Basic Health Screen at 3 months and 9 months

  baseline, 3-months, 9-months

• Change from baseline Activities of daily Living (ADL) at 3 months and 9 months

  baseline, 3-months, 9-months

• Change from baseline Instrumental Activities of Daily Living (IADL) at 3 months and 9 months

  baseline, 3-months, 9-months

• Change from baseline Geriatric Depression Scale (GDS) at 3 months and 9 months

  baseline, 3-months, 9-months

• Change from baseline Geriatric Anxiety Inventory (GAI) at 3 months and 9 months

  baseline, 3-months, 9-months

Other Outcomes (1)

• Demographic questionnaire

  Baseline

Study Arms (2)

Mindful Awareness Program

EXPERIMENTAL

18 sessions of mindful awareness program teaching the elderly mindful awareness practice techniques

Behavioral: Mindful Awareness Program

Health Education Program

ACTIVE COMPARATOR

18 sessions of health education program focusing on healthy living topics

Behavioral: Health Education Program

Interventions

Mindful Awareness Program BEHAVIORAL

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

Also known as: MAP

Mindful Awareness Program

Health Education Program BEHAVIORAL

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

Also known as: HEP

Health Education Program

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (1)

Training and Research Academy

Singapore, Singapore, 648886, Singapore

Location

Related Publications (15)

• 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.

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• Moverare-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.

  PMID: 22210159 BACKGROUND

• Huang L, Jia J, Liu R. Decreased serum levels of the angiogenic factors VEGF and TGF-beta1 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.

  PMID: 23827227 BACKGROUND

• Gard T, Holzel 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.

  PMID: 24571182 BACKGROUND

• 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.

  PMID: 19735247 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 24120430 BACKGROUND

• 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. doi: 10.1097/01.psy.0000077505.67574.e3.

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• 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.

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

  BACKGROUND

• 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. doi: 10.3758/bf03196772.

  PMID: 16523997 BACKGROUND

• Lee TM, Chan CC. Are trail making and color trails tests of equivalent constructs? J Clin Exp Neuropsychol. 2000 Aug;22(4):529-34. doi: 10.1076/1380-3395(200008)22:4;1-0;FT529.

  PMID: 10923062 BACKGROUND

• 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

  BACKGROUND

• Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4. doi: 10.1212/wnl.43.11.2412-a. No abstract available.

  PMID: 8232972 BACKGROUND

• 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.

  PMID: 18596974 BACKGROUND

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Rathi Mahendran, Ph.D

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant Psychiatrist

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 10, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 18, 2015

Record last verified: 2015-08

Locations

SG (1)