Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 17-000290
NCT ID: NCT03095170
Sponsor Protocol Number: 17-000290
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
For the patients diagnosed with MCI:
- Written informed consent for participation. Patient also needs to sign a legally authorized representative (LAR) addendum should MCI patient become incapacitated
- A diagnosis of amnestic MCI (single domain or multi-domain)
- A Clinical Dementia Rating scale score of 0 or 0.5
- At least 50.
- Either not taking or stable on nootropic(s) and/or pain medication for at least 3 months.
- Fluent in English.
- A score of at least 25 on the Telephone Interview for Cognitive Status for Memory.
For the care partners:
- Written informed consent for participation.
- At least 21 years of age.
- A score of at least 32 on the Telephone Interview for Cognitive Status for Memory.
- Partner has at least twice-weekly contact with the participant.
Exclusion Criteria:
For the patients diagnosed with MCI:
- MRI contraindications (e.g., ferrous metal in the body, claustrophobia, pregnancy)
- 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:
- Physical impairments, language comprehension deficits, or significant hearing disturbances that would limit ability to perform tasks or participation in the intervention.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Melanie Chandler, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available