Clinical trial NCT03095170: Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder
Official title: Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mild Cognitive Impairment
Memory Disorders
Mild Dementia
Impaired Cognition
Mild Cognitive Disorder
Amnestic Disorder
Dementia and Amnestic Conditions
Poor Short-term Memory
Memory Impairment
Mild Neurocognitive Disorder
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: Tallahassee Memorial HealthCare
name: Florida Department of Health
First posted: 2017-03-29
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Resting State Magnetic Resonance Imaging (MRI)
timeFrame: baseline to 7.5 months
Secondary outcomes:
measure: Diffusion Tensor Imaging (DTI)
timeFrame: baseline to 7.5 Months
Other outcomes:
measure: improvement in patient memory based everyday functioning
timeFrame: baseline to 7.5 Months
measure: improvement in patient and care partner quality of life
timeFrame: baseline to 7.5 Months
measure: improvement in patient and carepartner mood
timeFrame: baseline to 7.5 Months
measure: improvement in patient cognitive functioning
timeFrame: baseline to 7.5 Months
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Glenn Smith, Ph. D
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Wit L, O'Shea D, Chandler M, Bhaskar T, Tanner J, Vemuri P, Crook J, Morris M, Smith G. Physical exercise and cognitive engagement outcomes for mild neurocognitive disorder: a group-randomized pilot trial. Trials. 2018 Oct 19;19(1):573. doi: 10.1186/s13063-018-2865-3.