Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618807
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Neuro RX Gamma v2 for MCI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Study Evaluating the Feasibility Safety and Efficacy of the Neuro RX Gamma Version 2 for the Treatment of Mild Cognitive Impairment MCI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PBMCI2
Brief Summary:
Mild cognitive impairment MCI is a transitional risk state that occurs between the normal aging process and Alzheimers dementia AD On average 32 of patients with MCI will progress to dementia 62 will stay stable and about 6 will return to normal cognition at subsequent visits
Current treatment for MCI includes cholinesterase inhibitors donepezil galantamine and rivastigmine and NMDA receptor antagonists memantine which delay or slow the worsening of symptoms and treat cognitive symptoms memory loss confusion and problems with thinking and reasoning Despite currently ongoing drug studies and modest clinical benefits of currently approved drug treatments there continues to remain a need for treatments for long term symptomatic improvement of MCI with fewer and less severe side effects
Photobiomodulation PBM therapy also called low-level laser or light therapy LLLT is a safe non-invasive non-thermal no significant heat is generated method of therapy which uses either visible red or near-infrared NIR light to stimulate heal and repair damaged or dying tissue cells This study proposes to use the Neuro RX Gamma device version 2 to deliver NIR light energy to particular brain regions which are dysfunctional in MCI participants
Current treatment for MCI includes cholinesterase inhibitors donepezil galantamine and rivastigmine and NMDA receptor antagonists memantine which delay or slow the worsening of symptoms and treat cognitive symptoms memory loss confusion and problems with thinking and reasoning Despite currently ongoing drug studies and modest clinical benefits of currently approved drug treatments there continues to remain a need for treatments for long term symptomatic improvement of MCI with fewer and less severe side effects
Photobiomodulation PBM therapy also called low-level laser or light therapy LLLT is a safe non-invasive non-thermal no significant heat is generated method of therapy which uses either visible red or near-infrared NIR light to stimulate heal and repair damaged or dying tissue cells This study proposes to use the Neuro RX Gamma device version 2 to deliver NIR light energy to particular brain regions which are dysfunctional in MCI participants
Detailed Description:
This study will recruit approximately 60 participants with MCI for the study and the total expected duration of the participants participation in the study is 12 weeks The active and sham Neuro RX gamma device v2 consists of a headset with a built-in controller and nasal applicator The nasal applicator contains a single LED and will be placed into the nostril and clipped into place The headset is a wearable applicator that may be adjusted It consists of 5 LEDs A red star symbol identifies the front of the headset and helps the user orientate the headset on the head LEDs are semiconductor electronic components that emit light
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None