Improving Neurological Health in Aging Via Neuroplasticity-based Computerized Exercise

NCT04149457 | Completed DMC

• 1 other identifier: PSC-0903-19
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Aging

Outcome Measures

Primary Outcomes (1)

• Change in FEOVB uptake through PET Imaging

  18F-fluoroethoxybenzovesamicol (FEOBV) uptake as measured through Positron Emission Tomography (PET) ligand imaging.

  At 3 months (post-intervention)

Other Outcomes (6)

• Change in EXAMINER Executive Composite Score

  At 3 months (post-intervention) and at 6 months (follow-up)

• Change in Useful Field of View (UFOV) Score

  At 3 months (post-intervention) and at 6 months (follow-up)

• Change in Tonic and Phasic Alertness (TAPAT) Score

  At 0 months (pre-intervention), at 3 months (post-intervention) and at 6 months (follow-up)

Study Arms (2)

Experimental Treatment

EXPERIMENTAL

Computerized plasticity-based adaptive cognitive training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.

Other: Computerized Plasticity-Based Adaptive Cognitive Training

Active Comparator

ACTIVE COMPARATOR

Commercially available computerized training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.

Other: Commercially available computerized training

Interventions

Computerized Plasticity-Based Adaptive Cognitive Training OTHER

Thirty minutes of training on computerized exercises that targets visual processing speed, memory, attention and alertness.

Experimental Treatment

Commercially available computerized training OTHER

Thirty minutes of training on computerized, casual video games.

Active Comparator

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Potential participant must be 65+ years old at the time of study screening.
• Potential participant should achieve a score of ≥ 23 on the Montreal Cognitive Assessment (MoCA).
• Potential participant must be likely able to compete all primary outcome measures in the judgment of the consenting study staff person.
• Potential participant must demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in this research study.
• Potential participant must have the visual, auditory, and motors capacity to use the computerized intervention in the judgment of the consenting study staff person.
• Potential participant must already have, be willing to obtain, or be willing to travel to locations with WiFi connectivity to complete intervention activities.
• Potential participant must be able to communicate in either English or French.

You may not qualify if:

• Potential participant should not have an existing diagnosis of major or minor neurocognitive disorder at screening.
• Potential participants with active suicidal ideation with specific plan and intent or suicide-related behaviors within 2 months of consent as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
• Potential participant should not have a Geriatric Depression Scale (GDS) score of \>10.
• Potential participant should not have been treated within 5 years of the date of consent with a computer-based cognitive training program manufactured by Posit Science.
• Potential participant should not be participating in a concurrent clinical trial (involving an investigational pharmaceutical, behavioral treatment, medical device or other) that, in the judgment of the Site Principal Investigator, could affect the outcome of this study.
• Potential participant may not be pregnant and should not have claustrophobia or implantation with any medical devices above the waist that may concentrate radio frequency fields, or have other medical issues that may frustrate participation in MRI imaging procedures.
• Potential participant should not have medical illnesses deemed to interfere with participation in study activities and/or unstable and/or untreated conditions that may affect cognition, including substance abuse/dependence disorders, drugs that interfere with cholinergic function, ongoing chemotherapy or other cancer treatment.
• Potential participant who shows signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) will be excluded.

Sponsors & Collaborators

• Posit Science Corporation: lead
• McGill University: collaborator

Study Sites (1)

McGill University

Montreal, Quebec, H3A 2B4, Canada

Location

Related Publications (2)

• Attarha M, de Figueiredo Pelegrino AC, Toussaint PJ, Grant SJ, Van Vleet T, de Villers-Sidani E. Improving Neurological Health in Aging Via Neuroplasticity-Based Computerized Exercise: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Aug 8;13:e59705. doi: 10.2196/59705.

  PMID: 39116435 BACKGROUND

• Attarha M, de Figueiredo Pelegrino A, Ouellet L, Toussaint PJ, Grant SJ, Van Vleet T, de Villers-Sidani E. Effects of Computerized Cognitive Training on Vesicular Acetylcholine Transporter Levels using [18F]Fluoroethoxybenzovesamicol Positron Emission Tomography in Healthy Older Adults: Results from the Improving Neurological Health in Aging via Neuroplasticity-based Computerized Exercise (INHANCE) Randomized Clinical Trial. JMIR Serious Games. 2025 Oct 13;13:e75161. doi: 10.2196/75161.

  PMID: 41084791 DERIVED

Related Links

• Two years after trial completion (on May 31, 2026), the INHANCE dataset will be made available to verified academic and industry researchers. Investigators can conduct both confirmatory and exploratory analyses using LORIS.

Study Officials

• Thomas Van Vleet, PhD

  Posit Science Corporation

  PRINCIPAL INVESTIGATOR

• Mouna Attarha, PhD

  Posit Science Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: November 4, 2019
• Study Start: July 16, 2021
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)