Advantage of Cerebellar Transcranial Magnetic Stimulation in Alzheimer's Diseases （ACT-AD）
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorXijing Hospital
About this trial
Alzheimer's Disease (AD) is the primary cause of dementia, with its prominent feature being cognitive decline. The cerebellum plays a crucial role in cognitive processing, making it a potential target for therapeutic intervention. This study will be conducted to evaluate the efficacy and safety of cerebellar Intermittent theta-burst stimulation (CRB-iTBS) in participants with mild Alzheimer's disease on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 3 months of treatment in the Core Study. This project aims to provide a valid treatment to improve the cognitive function and quality of life for those with Alzheimer's disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 50-85 years old
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)
MMSE score ranges from 18-26 points; CDR score 0.5-1 points
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
Disqualifiers
Neurodegenerative disorders other than AD.
Significant intracranial focal or vascular pathology seen on brain MRI scan
History of seizure (with the exception of febrile seizures in childhood)
Major depressive disorder (current)
Trial design
Design model
Parallel
Treatments tested in this trial
Intermittent Theta-Burst Transcranial Magnetic Stimulation
Device50Hz, stimulation intensity of 100% RMT, duration of 40s as a group of stimulation, 600 stimulation pulses, repeated stimulation of bilateral cerebellar dentate nuclei, with a 5-minute interval between each group, 1200 stimulation pulses per site, 5 times a week, treatment for 4 weeks, then treat once a week for 8 weeks.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: ArmsActive comparator 1 intervention
Group B: Assigned InterventionsSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
The changes in CDR-SB（Clinical Dementia Rating-Sum of Boxes）
The changes in CDR-SB will constitute the major research outcome measure used to assess response to rTMS.There are two scoring methods for the CDR scale, namely Total Score Calculation (CDR-GS) and Sum of Six Content Calculation (CDR-SB). The scoring method used in this study is CDR-SB, with a total score of 18 points. The lower the score, the milder the symptoms
Time frame
baseline, 12 weeks after start of the treatmentSecondary outcomes
1
The changes in MMSE（Mini Mental State Examination）
The changes in MMSE will constitute the secondary research outcome.The full name of MMSE is mini-mental state examination. The higher the score, the better. In this study, changes in MMSE scores before and after treatment were used as secondary observations.
Time frame
baseline, 12 weeks ,24 weeks and 36 weeks after start of the treatment2
The changes in ADCS-ADL（Alzheimer's Disease Cooperative Study - Activities of Daily Living）
ADCS-ADL total score is 54 points, the higher the score，the lighter the symptoms.
Time frame
baseline, 12 weeks, 24 weeks and 36 weeks after start of the treatment3
The changes in NPI（Neuropsychiatric Inventory）
The changes in NPI will constitute the secondary research outcome. The Neuropsychology Scale (NPI) evaluates 12 neuropsychiatric disorders which included 10 neuropsychiatric symptoms and 2 autonomic neurological symptoms based on the caregiver's perception of the patient's behavior and the perceived distress. The lower the score, the lighter the symptoms.
Time frame
baseline, 12 weeks, 24 weeks and 36 weeks after treatment4
The changes in MRI（Magnetic Resonance Imaging）
This study mainly applied resting blood oxygen level dependent functional magnetic resonance imaging (BOLD), arterial spin labeling (ASL), and magnetic resonance diffusion tensor imaging (DTI) techniques to evaluate the changes in functional connectivity of the cerebellar dentate nucleus in healthy subjects and patients before and after 12 weeks of TMS treatment, as well as the changes in the cerebellar cortical white matter fiber bundles two month after treatment.
Time frame
baseline and 12 weeks after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Xijing Hospital
Lead sponsor
Tang-Du Hospital
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
Xi'an No.3 Hospital
Collaborator
Source ClinicalTrials.gov