Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-01-14 @ 1:18 AM
Study NCT ID:
NCT07243600
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Neurological Health With Acetylcholine Via Neuroplasticity-based Computerized Exercise in Mild Cognitive Impairment
Sponsor:
Posit Science Corporation
Organization:
Study Overview
Official Title:
Improving Neurological Health With Acetylcholine Via Neuroplasticity-based Computerized Exercise in Mild Cognitive Impairment (INHANCE-MCI)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INHANCE-MCI
Brief Summary:
This study is a validation study to evaluate efficacy of two neuroplasticity-based, computerized cognitive training programs to improve neurological and neuropsychological health in older adults with mild cognitive impairment (MCI).
Detailed Description:
The primary objective of this study is to evaluate will evaluate the impact of speed training to change cholinergic signaling, cognitive performance, and functional abilities in patients with MCI, as evidenced by \[18F\]fluoroethoxybenzovesamicol (FEOBV) positron-emission tomography (PET) and standard measures of cognition and function.
The investigators will employ a prospective, double-blind, parallel-arm, active-controlled, randomized clinical trial in patients with clinically-defined mild cognitive impairment aged 65 and above with a baseline MoCA of 18-26 inclusive.
Approximately 84 participants will be consented to ensure the successful completion of at least 70 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 speed-based brain training or an active control of visual non-speeded computerized games and will engage in approximately 35 hours of program use for the 10-week Intervention Period. Following the 10-week intervention, participants will complete a Post-Intervention (V2) 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 (V3) end-of-study assessment and PET imaging to evaluate the endurance of changes in cognition, function, and behavior in the absence of further program use.
The investigators will employ a prospective, double-blind, parallel-arm, active-controlled, randomized clinical trial in patients with clinically-defined mild cognitive impairment aged 65 and above with a baseline MoCA of 18-26 inclusive.
Approximately 84 participants will be consented to ensure the successful completion of at least 70 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 speed-based brain training or an active control of visual non-speeded computerized games and will engage in approximately 35 hours of program use for the 10-week Intervention Period. Following the 10-week intervention, participants will complete a Post-Intervention (V2) 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 (V3) end-of-study assessment and PET imaging to evaluate the endurance of changes in cognition, function, and behavior in the absence of further program use.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: