Actively Recruiting
High Definition Transcranial Direct Current Stimulation (HD-tDCS) Combined with Cognitive Training for Early Alzheimer's Disease
Led by Anhui Medical University · Updated on 2025-07-11
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects and brain mechanisms of high-definition transcranial direct current stimulation (HD-tDCS) combined with cognitive training in people with early Alzheimer's disease. This study uses a double-blind, randomized design to compare anode tDCS with cognitive training, anode tDCS alone, and a sham stimulation group. It aims to understand how these interventions influence memory and cognitive functions in this population. Participants receive treatment over two weeks, with HD-tDCS administered daily for 30 minutes at 2 mA targeting the left dorsolateral prefrontal cortex. The cognitive training involves daily 30-minute sessions of computerized, multi-domain adaptive tasks covering memory, attention, reasoning, and other cognitive areas. The sham group receives brief stimulation only. About 20 participants are assigned to each of the three groups. Throughout the study, participants undergo extensive cognitive and neuropsychological testing before, during, and after treatment, including assessments like the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), Montreal Cognitive Assessment (MoCA), and various memory and executive function tests. Brain scans using multimodal MRI and EEG recordings are performed. Follow-up evaluations occur one week, two weeks, one month, and three months after treatment to monitor changes and safety, providing a detailed picture of cognitive and brain function over time.
CONDITIONS
Brief Title
High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Early Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with early Alzheimer's disease or related diseases according to NINCDS-ACDRADA criteria
- Mini Mental State Examination (MMSE) score between 10 and 27
- Clinical Dementia Rating (CDR) score of 2 or less
- Receiving IAChE treatment for at least 3 months
- 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 severe psychiatric illnesses such as major depression, psychosis, or obsessive-compulsive disorder
- History of head injury, stroke, or other neurological diseases
- Organic brain defects seen on T1 or T2 MRI images
- History of seizures or unexplained loss of consciousness
- Presence of implanted devices like pacemaker, medication pump, vagal stimulator, or deep brain stimulator
- Family history of medication refractory epilepsy
- History of 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) for cognitive assessments, neuropsychological tests, MRI scan, and EEG recording to determine eligibility
Duration - 2 weeks
Participants receive 10 days of daily high definition transcranial direct current stimulation (HD-tDCS) with or without cognitive training over two weeks.
Daily visits for 10 stimulation sessions and cognitive training sessions as assigned
Duration - 3 months
Participants undergo cognitive and neuropsychological assessments, MRI scan, EEG recording, and safety evaluations at multiple time points after treatment to monitor changes and adverse events.
Visits at 1 week, 2 weeks (end of treatment), 1 month, and 3 months post-treatment
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
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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