Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04784416
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2021-03-02
Brief Title:
Transcranial Photobiomodulation for Alzheimers Disease TRAP-AD
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Transcranial Photobiomodulation for Alzheimers Disease TRAP-AD
Status:
RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
This multi-site study will be the first to evaluate the dose-dependent effects of t-PBM in amnestic Mild Cognitive Impairment aMCI and early Alzheimers Disease AD CDR of 05-1 FAST 1-4 age 65-85 in a randomized clinical trial of 8 weeks of t-PBM vs sham At baseline all subjects will complete initial neuropsychological testing To elucidate mechanisms of action of t-PBM prior to treatment subjects will undergo neuroimaging related to critical features of AD tau 18F MK-6240 load PET measures of brain bioenergetics 31P-MRS and functional connectivity rs-fMRI After undergoing target engagement testing t-PBM session performed during fMRI to detect BOLD changes with active t-PBM subjects will then be randomized to t-PBMsham and complete 24 t-PBMsham treatments 11 min per day 3 days per week for 8 weeks t-PBM will be administered via continuous 808 nm wavelength laser delivery to the forehead bilaterally at standard EEG electrode positions F4 F3
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None