NCT06088121

Study to Evaluate the Efficacy and Safety of ATNC-MDD V1(TMS With Cognitive Training) in Mild Alzheimer's Dementia

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: Advanced Technology & Communications · Industry
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

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 treatment/sham. 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.

Conditions

• Alzheimer's Disease
• Dementia
• Brain Diseases
• Central Nervous System Diseases
• Nervous System Diseases
• Neurodegenerative Diseases
• Neurocognitive Disorders
• Mental Disorder

Interventions

Type	Name	Description
DEVICE	ATNC MDD-V1 (Real TMS + Real Cog)	Synchronized TMS and cognitive stimulation to 6 brain areas.
DEVICE	ATNC MDD-V1 (Sham TMS + Real Cog)	Sham device, has the same appearance and sound as the real device, combined with real cognitive exercises. Patients come for the same number of sessions, delivers no real stimulation or cognitive training.
DEVICE	ATNC BN-V1	The navigation system is used to determine the exact brain location to be stimulated (coordinates for the stimulation point).
DEVICE	ATNC BN-V2	The navigation system is used to determine the exact brain location to be stimulated (coordinates for the stimulation point).

Timeline

• Start date: 2023-05-15
• Primary completion: 2027-01-15
• Completion: 2027-06-30
• First posted: 2023-10-18
• Last updated: 2025-10-03

Locations

11 sites across 1 country: South Korea