Study to Evaluate the Efficacy and Safety of ATNC-MDD V1(TMS With Cognitive Training) in Mild Alz… (NCT06088121) | Clinical Trial Compass
RecruitingNot Applicable
Study to Evaluate the Efficacy and Safety of ATNC-MDD V1(TMS With Cognitive Training) in Mild Alzheimer's Dementia
South Korea180 participantsStarted 2023-05-15
Plain-language 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.
Who can participate
Age range60 Years – 85 Years
SexALL
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Inclusion criteria
✓. Patients who started drug treatment with an acetylcholinesterase inhibitor at least 2 months before participating in the clinical trial and can participate in the clinical trial without changing the dose during the trial period.
✓. Male or female age 60-85 years.
✓. Patients diagnosed with mild stage of Alzheimer's Disease, according to the NIA-AA (2011) diagnosis.
✓. A patient whose dementia was confirmed to be due to Alzheimer's disease by amyloid PET-CT.
✓. MMSE score 21 to 26.
✓. CDR 1 or GDS 3.
✓. A patient who is deemed physically eligible for the clinical trial based on medical records and physical examination.
✓. A patient who is unable to provide voluntary informed consent for the clinical trial due to impaired decision-making capacity, for whom a legally authorized representative provides consent for participation, and who can attend follow-up visits with a caregiver.
Exclusion criteria
✕. Patients with central nervous system (CNS) disorders that may affect cognitive function (such as cerebrovascular diseases including vascular dementia, subdural hematoma, normal pressure hydrocephalus, brain tumors, CNS infections like HIV or syphilis, head trauma, Huntington's disease, Parkinson's disease, etc.) where cognitive decline may be explained by other causes, or in whom dementia types other than Alzheimer's disease are suspected.
✕. Patients who have been unconscious due to brain surgery or concussion, or who have signs or symptoms of cranial pressure elevation on neurologic examination.
✕. Patients with a history of drug abuse, including alcohol, in the past 5 years from the time of screening.
✕. Patients with schizophrenia, schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, post-traumatic stress, severe anxiety, mental retardation, DSM-V disorder.
✕. Patients with abnormal vitamin B12, folic acid deficiency, or thyroid stimulating hormone (TSH) test results that were considered by the investigator to affect or are caused by the severity of dementia.
✕. Patients with metal implants in the head, (i.e. cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants.