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DementiaMAPRCTNCT02286791

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

A study testing Mindful Awareness Program and Health Education Program in people with Dementia, run by National University of Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Dementia
What is being tested?
Mindful Awareness Program and Health Education Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteSingapore
Study dates
Sep 2014to Jun 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Training and Research Academy

    Singapore, Singapore, 648886

Other trials in Singapore

About this study

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.

Read the detailed 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.

Conditions
Dementia
Being tested
Mindful Awareness Program, Health Education Program
Keywords
Prevention of dementia, Mindful awareness program, Mild cognitive impairment, Mindfulness, Elderly, Cognitive decline
Medical subject headings
Dementia, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindful Awareness ProgramBehavioural

    Also called MAP

    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 ProgramBehavioural

    Also called HEP

    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

Study groups in NCT02286791
Study groupRoleWhat they receive
Mindful Awareness ProgramExperimental18 sessions of mindful awareness program teaching the elderly mindful awareness practice techniques
Receives: Behavioral: Mindful Awareness Program
Health Education ProgramActive comparator18 sessions of health education program focusing on healthy living topics
Receives: Behavioral: Health Education Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline, 3-months, 9-months

  2. 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.

    Measured: baseline, 3-months, 9-months

  3. 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.

    Measured: baseline, 3-months, 9-months

  4. 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.

    Measured: baseline, 3-months, 9-months

  5. 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.

    Measured: baseline, 3-months, 9-months

  6. 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.

    Measured: baseline, 3-months, 9-months

  7. Change from baseline Semantic Verbal Fluency (Animals) at 3 months and 9 months

    Semantic Verbal Fluency (Animals) taps lexical knowledge and semantic memory organization.

    Measured: baseline, 3-months, 9-months

  8. 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.

    Measured: baseline, 3-months

  9. 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.

    Measured: baseline, 3-months, 9-months

  10. 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.

    Measured: baseline, 9-months

  11. 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.

    Measured: baseline,3 months, 9 months

  12. 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).

    Measured: baseline,3 months, 9 months

Secondary outcomes (5)

  1. Change from baseline Basic Health Screen at 3 months and 9 months

    the Blood pressure, Pulse rate, Height and Weight will be measured.

    Measured: baseline, 3-months, 9-months

  2. 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.

    Measured: baseline, 3-months, 9-months

  3. 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.

    Measured: baseline, 3-months, 9-months

  4. 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.

    Measured: baseline, 3-months, 9-months

  5. 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.

    Measured: baseline, 3-months, 9-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02286791
Sponsor's protocol ID
B-14-110
Acronym
MAPRCT
Status last verified
Aug 2015
First submitted
3 Nov 2014
Last updated
18 Aug 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19751919

  • 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.

    PubMed 22210159

  • 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.

    PubMed 23827227

  • 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.

    PubMed 24571182

  • 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.

    PubMed 19735247

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

  • 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.

    PubMed 24120430

  • 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.

    PubMed 12883106

  • 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.

    PubMed 22815014

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

  • 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.

    PubMed 16523997

  • 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.

    PubMed 10923062

  • 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

  • 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.

    PubMed 8232972

  • 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.

    PubMed 18596974

Questions about this trial

What is this clinical trial studying?

A study testing Mindful Awareness Program and Health Education Program in people with Dementia, run by National University of Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline Mini-Mental State Examination (MMSE) at 3 months and 9 months (time frame: baseline, 3-months, 9-months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02286791, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2015.

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