Advantage of Cerebellar Transcranial Magnetic Stimulation in Alzheimer's Diseases （ACT-AD）

Launched by XIJING HOSPITAL · Oct 31, 2024

Keywords

ClinConnect Summary

The ACT-AD trial is studying a new treatment approach for people with mild Alzheimer's disease. Researchers are looking at a technique called cerebellar Intermittent theta-burst stimulation (CRB-iTBS), which uses magnetic pulses to stimulate a part of the brain known as the cerebellum. This area is important for thinking and memory, and the goal is to see if this treatment can help improve cognitive function and overall quality of life for individuals living with Alzheimer's. The main focus will be on assessing changes in cognitive abilities over a three-month period.

To participate in this trial, individuals need to be between the ages of 50 and 85 and should have a diagnosis of mild Alzheimer's disease, confirmed by specific tests. They should also be stable on their current medications for at least three months and have a caregiver to help them throughout the study. Participants can expect to undergo the CRB-iTBS treatment while being monitored for safety and effectiveness. It's important to note that certain conditions, such as other neurodegenerative disorders or serious medical issues, may prevent someone from joining the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age: 50-85 years old
• • 2. Meet the core clinical criteria of NIA-AA for possible Alzheimer's disease dementia, and PET or cerebrospinal fluid markers show elevated p-tau and decreased A β (1-42)
• • 3. MMSE score ranges from 18-26 points; CDR score 0.5-1 points
• • 4. The patient has received treatment with acetylcholinesterase inhibitors (AChEI), NMDA receptor antagonists, or mannequine therapy, and the current dosing regimen has remained stable for the 12 weeks prior to baseline assessment
• • 5. At least one adult caregiver
• • 6. The patient or legal guardian voluntarily signs the informed consent form
• Exclusion Criteria:
• • 1. Neurodegenerative disorders other than AD.
• • 2. Significant intracranial focal or vascular pathology seen on brain MRI scan
• • 3. History of seizure (with the exception of febrile seizures in childhood)
• 4. Any of the following psychotic disorders (DSM IV-TR criteria):
• • Major depressive disorder (current)
• • Schizophrenia
• • Other psychotic disorders, bipolar disorder, or substance related disorders (within the past 5 years)
• • 5. GDS score ≥ 8 points in baseline assessment
• • 6. Cerebrovascular disease, severe infection, malignant tumor, or severe dysfunction of organs such as heart, liver, and kidney.
• • 7. Pregnant or lactating women
• • 8. Contraindications for TMS or MRI, metal or implanted devices in the body (such as pacemakers, deep brain stimulators).
• • 9. Participate in AD related clinical trials within 6 months prior to research registration