Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder

Not Applicable

Terminated

• Conditions: Memory Disorders; Amnestic Disorder; Memory Impairment; Impaired Cognition; Mild Cognitive Disorder; Dementia and Amnestic Conditions; Poor Short-term Memory; Mild Cognitive Impairment; Mild Dementia; Mild Neurocognitive Disorder

• Registration Number: NCT03095170
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-23
• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-29
• Primary Completion: 2022-03-21
• Study Completion: 2022-03-21
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Resting State Magnetic Resonance Imaging (MRI)	baseline to 7.5 months	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.

Secondary Outcome Measures

Name	Time	Method
Diffusion Tensor Imaging (DTI)	baseline to 7.5 Months	DTI will be used to map white matter tractography in the brain.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States