Mild Cognitive Impairment Clinical Trial
Official title:
Art Therapy and Music Reminiscence Activity in the Prevention of Cognitive Decline
Verified date | January 2018 |
Source | National University, Singapore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to determine the impact of Art Therapy and Music Reminiscence
Activity on cognition in community living elderly with Mild Cognitive Impairment (DSM V: Mild
Neurocognitive Disorder) using a randomized control design.
Specifically, the structural cerebral changes that occur with the two interventions and the
extent to which the therapies may reverse cognitive impairment and/or prevent further
cognitive decline, will be determined.
The hypothesis is that participants in both active intervention arms will perform better on
neuropsychological tests of cognition and will show positive changes on functional imaging
studies compared to controls who will not receive any intervention. Participants in the
interventions will also have positive changes in blood biomarkers, enhanced psychological
well-being and reductions in anxiety and depressive symptoms compared to the control group.
No a priori hypotheses were developed as to whether Art Therapy or Music Reminiscence
Activity is more effective as the comparison is exploratory.
Status | Completed |
Enrollment | 68 |
Est. completion date | May 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Older person between 60 and 85 years of age, living in the community and fulfills the operational criteria/definition of MCI: 1. At least one age-education adjusted neuropsychological test Z score <-1.5 2. Do not meet DSM V criteria for a Major Neurocognitive Disorder 3. Memory/Cognitive complaint preferably corroborated by a reliable informant 4. Intact Activities of Daily Living - Functions independently - Does not have dementia - Able to travel to the data collection site on their own and participate in the activity Exclusion Criteria: - Those who do not meet the above inclusion criteria (ie. do not have a MCI diagnosis) - Those with Dementia/Major Neurocognitive Disorder or Normal Ageing - Presence of a neurological condition e.g. epilepsy, Parkinson Disease, stroke - Presence of a major psychiatric disorder e.g. Major Depression, Psychoses - Terminal illness e.g. cancer - Presence of significant visual and/or hearing impairment and Color Blindness - Participants in another intervention study at the same time |
Country | Name | City | State |
---|---|---|---|
Singapore | Training and Research Academy | Singapore |
Lead Sponsor | Collaborator |
---|---|
National University, Singapore |
Singapore,
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Koepsell TD, Monsell SE. Reversion from mild cognitive impairment to normal or near-normal cognition: risk factors and prognosis. Neurology. 2012 Oct 9;79(15):1591-8. doi: 10.1212/WNL.0b013e31826e26b7. Epub 2012 Sep 26. — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neuropsychological Test: Change from baseline in Rey Auditory Verbal Learning Test scores at 3 months and 9 months | Measure: Number of items from a list of 15 items participant is able to recall immediately and 30 minutes later. | Measured at Baseline, 3 months and 9 months | |
Primary | Neuropsychological Test: Change from baseline in Digit Span Task scores at 3 months and 9 months | Digit Span Task [(Digit Span Forward (DSF) and Digit Span Backward (DSB)] DSF Measure: 1 point for each correct sub-item response, Minimum: 0; Maximum 16 DSB Measure: 1 point for each correct sub-item response, Minimum: 0; Maximum 14 |
Measured at Baseline, 3 months and 9 months | |
Primary | Neuropsychological Test: Change from baseline in Colour Trails Test scores at 3 months and 9 months | Colour Trails Test (CTT) 1 and 2 Measure: Time to completion, in seconds for Trial 1 and Trial 2. Time Limit: 240s |
Measured at Baseline, 3 months and 9 months | |
Primary | Neuropsychological Test: Change from baseline in Block Design Test scores at 3 months and 9 months | Block Design (sub-test of the Wechsler Adult Intelligence Scale Tests) Measure: Respective sub-item test scores, based on time of completion and accuracy; Maximum score: 68 |
Measured at Baseline, 3 months and 9 months | |
Primary | Change from baseline fMRI scan at 3 months | Task-free Functional Magnetic Resonance Imaging (fMRI) will be employed to examine changes in functional connectivity. | Measured at Baseline and 3 months | |
Secondary | Change from baseline telomere lengths at 3 months and 9 months | Blood investigations to detect changes in telomere length | Measured at Baseline, 3 months and 9 months |
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