Effects of Memory Boot Camp on Brain Function in Adults With Symptoms of Mild Cognitive Impairment (MCI)

NCT04426162 | Completed

• 1 other identifier: 16-127
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 3

Brief Summary

This is a prospective controlled clinical trial to determine the effects of a 12-week Memory Boot Camp (MBC) program on cognitive function in older adults with symptoms of Mild Cognitive Impairment.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Change in Montreal Cognitive Assessment (MoCA)

  The MoCA is a validated, brief assessment tool that measures MCI and is widely used. Individuals are scored on seven different domains: visuospatial/executive, naming, attention, language, abstraction, delayed recall, and orientation.

  Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).

Other Outcomes (8)

• Change in Neurotrax BrainCare Testing Suite

  Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).

• Change in Beck Depression Inventory-II (BDI)

  Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).

• Change in Beck Anxiety Inventory (BAI)

  Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).

Study Arms (1)

Memory Boot Camp Participants

EXPERIMENTAL

All subjects undergo a 12-week control period, followed by a multi-domain 12-week memory program.

Other: Multi-domain Intervention

Interventions

Multi-domain Intervention OTHER

Intervention includes neurofeedback, heart rate variability biofeedback, memory and cognitive training, and one-on-one coaching to encourage behavior change in diet, sleep, physical fitness, and stress reduction.

Memory Boot Camp Participants

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjective memory concerns
• At least a high school education
• Having a current primary care doctor (or agreement to get a primary care doctor)
• Ability to read and write English
• Time availability of 4-5 hours/week
• Be in good general health

You may not qualify if:

• Major depression
• Known neurological illness (e.g. Alzheimer's or other dementia, Parkinson's, epilepsy, multiple sclerosis)
• Serious psychiatric diagnosis
• Substance abuse
• Complete blindness or deafness
• Plans to be out of town for more than 10 days during the active phase of the trial
• Current or past client of the Sponsor
• Complete blindness or deafness
• Employee or family member of Sponsor employee

Sponsors & Collaborators

• Neurocore: lead

Study Sites (3)

Neurocore Brain Performance Center

Boca Raton, Florida, 33431, United States

Location

Neurocore Brain Performance Center

Palm Beach Gardens, Florida, 33410, United States

Location

Neurocore Brain Performance Center

Grandville, Michigan, 49418, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: June 11, 2020
• Study Start: October 5, 2017
• Primary Completion: April 24, 2019
• Study Completion: April 24, 2019
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

US (3)