Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder (PEACEOFMND)

University of Florida

Status: Terminated

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

Treatments: Behavioral: Computerized brain fitness training; Behavioral: Wellness Education; Behavioral: Cognitive Rehabilitation; Behavioral: Yoga; Behavioral: Support Group (patient and partner)

Study type: Interventional

Funder types: Other

Identifiers

NCT03095170

OCR21041 (Other Identifier)

9AZ15 (Other Grant/Funding Number)

IRB201700004

7AZA1 (Other Grant/Funding Number)

IRB201900522 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 3 patient groups

Computerized brain fitness training

Experimental group

Description:

Will receive a 10 day intervention program (over 2 weeks) consisting of Computer Brain Fitness Training, Calendar Training and Support Group. After the initial two week intervention, there will be an extended period during which participants will continue the computerized brain fitness for another 24 weeks.Participants are encouraged to do at least two hours per week.

Treatment:

Behavioral: Cognitive Rehabilitation

Behavioral: Support Group (patient and partner)

Behavioral: Computerized brain fitness training

Yoga

Experimental group

Description:

Will receive a 10 day intervention program (over 2 weeks) consisting of Yoga, Calendar Training, and Support Group. After the initial two week intervention, there will be an extended period during which participants will continue yoga for 24 weeks. Participants assigned to the yoga intervention will continue to meet with their group and their yoga instructor for one hour per week and will be expected to do at least an additional hour of yoga by themselves every week.

Treatment:

Behavioral: Cognitive Rehabilitation

Behavioral: Yoga

Behavioral: Support Group (patient and partner)

Wellness Education

Active Comparator group

Description:

Will receive a 10 day intervention program (over 2 weeks) consisting of Wellness Education, Calendar Training and Support Group.

Treatment:

Behavioral: Wellness Education

Behavioral: Cognitive Rehabilitation

Behavioral: Support Group (patient and partner)