Actively Recruiting
Effect of Transcranial Alternating Current Stimulation (tACS) for Early Alzheimer's Disease
Led by Anhui Medical University · Updated on 2024-08-21
40
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects and brain mechanisms of transcranial alternating current stimulation (tACS) in people with early Alzheimer's disease. This study uses a randomized, double-blind design to compare real tACS treatment with a sham procedure, aiming to understand how this non-invasive brain stimulation affects cognition and symptoms in mild Alzheimer's cases. Participants are randomly assigned to receive either real tACS or sham tACS once daily for 14 consecutive days. Real tACS involves applying weak alternating electrical currents to the brain, while the sham group receives only brief ramp-up and ramp-down stimulation without ongoing current. Both groups undergo treatment at the First Affiliated Hospital of Anhui Medical University with masking to ensure unbiased assessments. Before treatment, patients complete a comprehensive set of cognitive, memory, emotional, and behavioral tests, including the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) as the primary outcome. Resting EEG data is collected, and assessments are repeated immediately after treatment and again two months later to measure changes. Safety and tolerability are monitored throughout. The main goal is to track cognitive changes and brain activity over a 12-week period following the treatment.
CONDITIONS
Brief Title
Effect of Transcranial Alternating Current Stimulation(tACS) for Early Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with early Alzheimer's disease or related conditions per NIA-AA criteria
- MMSE score between 10 and 27 indicating mild cognitive impairment or dementia
- Clinical Dementia Rating (CDR) score less than or equal to 2
- On IAChE treatment for at least 3 months
- Stable psychotropic treatments tolerated and unchanged for at least 3 months
You will not qualify if you...
- Clinical Dementia Rating (CDR) score greater than 2
- History or signs of major psychiatric illnesses such as major depression, psychosis, or obsessive-compulsive disorder
- History of head injury, stroke, or other neurological diseases
- Organic brain defects visible on T1 or T2 imaging
- History of seizures or unexplained loss of consciousness
- Presence of implanted devices such as pacemaker, medication pump, vagal stimulator, or deep brain stimulator
- Family history of medication-resistant epilepsy
- Substance abuse within the last 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 days
Participants complete a series of cognitive and neuropsychological assessments, including EEG, over two days to establish baseline measures before treatment.
2 visits (in-person)
Duration - 14 days
Participants receive either real or sham transcranial alternating current stimulation (tACS) once daily for 14 consecutive days.
14 daily visits (in-person)
Duration - 1 to 2 days
After the last treatment, participants undergo cognitive assessments and safety evaluations focusing on the past 14 days, including MoCA and associative memory tests.
1 to 2 visits (in-person)
Duration - 1 day
Two months after treatment, participants complete the same cognitive and neuropsychological assessments as at baseline, focusing on the past months.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Anhui Medical University
Hefei, Anhui, China, 230032
Actively Recruiting
Research Team
K
Kai Wang, PhD
X
Xingqi Wu, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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