Mild Cognitive Impairment Clinical Trial
— PEACEOFMNDOfficial title:
Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder
Verified date | June 2022 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Behavioral interventions currently provide the most useful approach to addressing the behavioral and social needs of those with Mild Cognitive Impairment (MCI) due to Alzheimer's or other diseases. This randomized, multisite, 3-arm study will investigate the impact of computerized brain fitness vs yoga vs an active control group (wellness education) on changes in cognitive function, daily functioning and quality of life in persons with Mild Cognitive Impairment (MCI) and their partner. In addition, in vivo neuroimaging measures of plasticity during the pre- and post-intervention periods will be measured and compared between the three different treatment groups. These neuroimaging measures of plasticity will be investigated in their relationship to the cognitive outcomes within each group.
Status | Terminated |
Enrollment | 5 |
Est. completion date | March 21, 2022 |
Est. primary completion date | March 21, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | For the patients diagnosed with MCI: Inclusion Criteria: 1. Written informed consent for participation. Patient also needs to sign a legally authorized representative (LAR) addendum should MCI patient become incapacitated 2. A diagnosis of amnestic MCI (single domain or multi-domain) 3. A Clinical Dementia Rating scale score of 0 or 0.5 4. At least 50. 5. Either not taking or stable on nootropic(s) and/or pain medication for at least 3 months. 6. Fluent in English. 7. A score of at least 25 on the Telephone Interview for Cognitive Status for Memory. Exclusion Criteria: 1. MRI contraindications (e.g., ferrous metal in the body, claustrophobia, pregnancy) 2. Physical impairments, language comprehension deficits, or significant hearing disturbances that would limit ability to perform tasks or participation in the intervention. For the care partners: Inclusion Criteria: 1. Written informed consent for participation. 2. At least 21 years of age. 3. A score of at least 32 on the Telephone Interview for Cognitive Status for Memory. 4. Partner has at least twice-weekly contact with the participant. Exclusion Criteria: 1. Physical impairments, language comprehension deficits, or significant hearing disturbances that would limit ability to perform tasks or participation in the intervention. |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | Florida Department of Health, Mayo Clinic, Tallahassee Memorial HealthCare |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | improvement in patient memory based everyday functioning | measured by the Everyday Cognitive Functioning scale (ECOG) | baseline to 7.5 Months | |
Other | improvement in patient and care partner quality of life | measured by the quality of life measured by the Quality of Life in Alzheimer's Disease scale (QOL-AD) | baseline to 7.5 Months | |
Other | improvement in patient and carepartner mood | measured by the Center for Epidemiological Studies-Depression (CESD) | baseline to 7.5 Months | |
Other | improvement in patient cognitive functioning | measured by the CogState | baseline to 7.5 Months | |
Primary | Resting State Magnetic Resonance Imaging (MRI) | Resting State MRI will allow us to investigate the functional connectivity in the brain, by looking at resting state networks such as the Default Mode Network. | baseline to 7.5 months | |
Secondary | Diffusion Tensor Imaging (DTI) | DTI will be used to map white matter tractography in the brain. | baseline to 7.5 Months |
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