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

• Register: ClinicalTrials.gov
• Last refreshed on: 24 August 2015
• Main ID: NCT02286791
• Date of registration: 03/11/2014
• Prospective Registration: No
• Primary sponsor: National University, Singapore
• Public title: Mindful Awareness Program for the Prevention of Dementia: A Randomized Controlled Trial MAPRCT
• Scientific title: Mindful Awareness Program for the Prevention of Dementia: A Randomized Controlled Trial
• Date of first enrolment: September 2014
• Target sample size: 55
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02286791
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

Singapore

Contacts

• Name: Rathi Mahendran, Ph.D
• Affiliation: National University, Singapore

Key inclusion & exclusion criteria

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



Age minimum: 60 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Dementia

Intervention(s)

Behavioral: Health Education Program

Behavioral: Mindful Awareness Program

Primary Outcome(s)

Change from baseline Biomarker - saliva sample at 3 months and 9 months [Time Frame: baseline,3 months, 9 months]

Change from baseline Mini-Mental State Examination (MMSE) at 3 months and 9 months [Time Frame: baseline, 3-months, 9-months]

Change from baseline Rey Auditory Verbal Learning Test (RAVLT) at 3 months and 9 months [Time Frame: baseline, 3-months, 9-months]

Change from baseline Biomarkers: blood sample at 3 months and 9 months [Time Frame: baseline, 3-months, 9-months]

Change from baseline Semantic Verbal Fluency (Animals) at 3 months and 9 months [Time Frame: baseline, 3-months, 9-months]

Change from baseline Biomarker - fecal sample at 3 months and 9 months [Time Frame: baseline,3 months, 9 months]

Change from baseline Biomarkers: urine sample at 9 months [Time Frame: baseline, 9-months]

Change from baseline Block Design at 3 months and 9 months [Time Frame: baseline, 3-months, 9-months]

Change from baseline Clinical Dementia Rating (CDR ) at 3 months and 9 months [Time Frame: baseline, 3-months, 9-months]

Change from baseline fMRI scan at 3 months [Time Frame: baseline, 3-months]

Change from baseline Colour Trails Tests (CTT) at 3 months and 9 months [Time Frame: baseline, 3-months, 9-months]

Change from baseline Digit Span Task at 3 months and 9 months [Time Frame: baseline, 3-months, 9-months]

Secondary Outcome(s)

Change from baseline Instrumental Activities of Daily Living (IADL) at 3 months and 9 months [Time Frame: baseline, 3-months, 9-months]

Change from baseline Activities of daily Living (ADL) at 3 months and 9 months [Time Frame: baseline, 3-months, 9-months]

Change from baseline Geriatric Depression Scale (GDS) at 3 months and 9 months [Time Frame: baseline, 3-months, 9-months]

Change from baseline Geriatric Anxiety Inventory (GAI) at 3 months and 9 months [Time Frame: baseline, 3-months, 9-months]

Change from baseline Basic Health Screen at 3 months and 9 months [Time Frame: baseline, 3-months, 9-months]

Secondary ID(s)

B-14-110

Source(s) of Monetary Support

Please refer to primary and secondary sponsors