Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06088121
Status:
RECRUITING
Last Update Posted:
2023-10-18
First Post:
2023-09-19
Brief Title:
Study to Evaluate the Efficacy and Safety of ATNC-MDD V1TMS With Cognitive Training in Mild Alzheimers Dementia
Sponsor:
Advanced Technology Communications
Organization:
Advanced Technology Communications
Study Overview
Official Title:
Effects of a ATNC MDD-V1 TMS With Cognitive Training for the Treatment of Mild Alzheimer Disease a Randomized Double-blinded Placebo-controlled Study
Status:
RECRUITING
Status Verified Date:
2024-07
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:
ATC-P001
Brief Summary:
The study tests the effect of the ATNC MDD-V1 on Alzheimer patients cognitive function The ATNC MDD-V1 uses non-invasive stimulation of both magnetic and cognitive training
Detailed Description:
The ATNC MDD-V1 system is a combined system of Transcranial Magnetic Stimulation and cognitive training and is a non-invasive therapeutic system for the improvement of Alzheimer patients cognitive function
A potential participant will undergo screening procedures to confirm eligibility to participate in the study followed by randomization procedure to one of the study groups - treatment or sham placebo Patient will attend the clinic 5 times a week for 6 weeks approximately an hour every day for treatmentsham The patient will be required to return to the clinic for follow-up
Up to 158 patients will be enrolled in up to 7 clinical sites in the Republic Korea
A potential participant will undergo screening procedures to confirm eligibility to participate in the study followed by randomization procedure to one of the study groups - treatment or sham placebo Patient will attend the clinic 5 times a week for 6 weeks approximately an hour every day for treatmentsham The patient will be required to return to the clinic for follow-up
Up to 158 patients will be enrolled in up to 7 clinical sites in the Republic Korea
Study Oversight
Has Oversight DMC:
None
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?:
None