NCT04149457

Improving Neurological Health in Aging Via Neuroplasticity-based Computerized Exercise

Improving Neurological Health in Aging Via Neuroplasticity-based Computerized Exercise (INHANCE)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Posit Science Corporation · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

This study is a validation study to evaluate efficacy of a neuroplasticity-based, computerized cognitive training program INHANCE (Improving Neurological Health in Aging via Neuroplasticity-based Computerized Exercise) to improve neurological and neuropsychological health in older adults.

Detailed description

The primary objective of this study is to evaluate the impact of a targeted speed and alertness training program (INHANCE) to improve cognition in healthy older adults, as evidenced by standard measures of cognition, and positive improvements in the neuromodulatory cholinergic system as measured via positron-emission tomography (PET). The investigators will employ a double-blind, parallel-arm, placebo-controlled, randomized clinical trial design comprised of a treatment group using INHANCE, a computerized program that trains speed of processing and attention, compared to an active control group using computer games in 92 healthy older adults. Approximately 108 participants will be consented to ensure the successful completion of 92 participants (post 20% attrition). Participants will then complete the Screening (V0) assessments to determine eligibility. Following inclusion, participants will complete the Baseline (V1) assessments, PET imaging and structural MRI scan; participants will then be randomized into either the INHANCE training or Computer Games, and will engage in approximately 35 hours of program use for the 10-week intervention period. Approximately halfway through the intervention period (\~5 weeks), participants will complete Interim (V2) assessments to be compared to the Post-Intervention assessments. Following the 10-week intervention, participants will complete a Post-Intervention (V3) assessment and PET imaging to evaluate changes in cognitive function. Participants will then stop using their assigned program for 3 months and return for a Follow-up (V4) end-of-study assessment to evaluate the endurance of changes in cognitive function in the absence of further program use. The protocol will be conducted in accordance with the protocol submitted to and approved by the National Institute on Health (NIH), and subject to Institutional Review Board review and approval prior to implementation.

Conditions

• Healthy Aging

Interventions

Type	Name	Description
OTHER	Computerized Plasticity-Based Adaptive Cognitive Training	Thirty minutes of training on computerized exercises that targets visual processing speed, memory, attention and alertness.
OTHER	Commercially available computerized training	Thirty minutes of training on computerized, casual video games.

Timeline

• Start date: 2021-07-16
• Primary completion: 2024-06-07
• Completion: 2024-06-07
• First posted: 2019-11-04
• Last updated: 2024-11-15

Locations

1 site across 1 country: Canada