Effect of Transcranial Alternating Current Stimulation(tACS) for Early Alzheimer's Disease
1 other identifier
interventional
40
1 country
1
Brief Summary
To investigate the clinical effect neural mechanism of transcranial alternating current stimulation in early Alzheimer's disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2024
CompletedFirst Submitted
Initial submission to the registry
August 14, 2024
CompletedFirst Posted
Study publicly available on registry
August 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedAugust 21, 2024
August 1, 2024
2 years
August 14, 2024
August 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alzheimers Disease Assessment Scale Cognitive section(ADAS-Cog)
The changes in Alzheimers Disease Assessment Scale Cognitive section (ADAS-Cog) will constitute the major research outcome measure used to assess response to transcranial alternating current stimulation (tACS).The ADAS-Cog scale is a scale used for clinical assessment of dementia patients with some memory efficiency tests, which can be used as an objective assessment of memory. The scale is considered a tool capable of providing a specific assessment of the severity of cognitive and non-cognitive behavioral impairments in people with Alzheimer's disease or dementia. The advantage of the ADAS-Cog compared to other scales used in the same clinical area is that its score quantifies clinical and impressionistic aspects of the patient assessed by the examiner, as well as objectively defined cognitive characteristics. The higher the ADAS-Cog score, the worse the cognitive function. The minimum value is 0 and the maximum is 86.
changes from baseline at 14 days and 12 weeks post-treatment
Secondary Outcomes (14)
electroencephalography
changes from baseline at 14 days and 12 weeks post-treatment
Associative Memory
changes from baseline at 14 days and 12 weeks post-treatment
MMSE(Mini Mental State Examination)
changes from baseline at 14 days and 12 weeks post-treatment
LMT (Logic Memory Test)
changes from baseline at 14 days and 12 weeks post-treatment
DST (Digital Span Test; Forward and Backward)
changes from baseline at 14 days and 12 weeks post-treatment
- +9 more secondary outcomes
Study Arms (2)
transcranial alternating current stimulation-Real
ACTIVE COMPARATORParticipants will receive real tACS once daily for 14 days
transcranial alternating current stimulation-Sham
SHAM COMPARATORParticipants will receive sham tACS once daily for 14 days
Interventions
Transcranial alternating current stimulation (tACS) is a non-invasive brain stimulation tool that alters cortical excitability and activity via application of weak alternating currents.
In the sham condition, tACS was delivered only during the ramp-up and ramp-down periods (30s); no current was delivered during the 30-minute intervention.
Eligibility Criteria
You may qualify if:
- Subject diagnosed with early Alzheimer's disease or related diseases according to NIA-AA criteria.
- Subjects must have a MMSE score between 10 and 27,indicating mild cognitive impairment or dementia.
- CDR score ≤ 2.
- Subject under treatment by IAChE for at least 3 months.
- psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months.
You may not qualify if:
- CDR \> 2
- Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).
- History of head injury,stroke,or other neurologic disease.
- Organic brain defects on T1 or T2 images.
- History of seizures or unexplained loss of consciousness.
- Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator.
- Family history of medication refractory epilepsy.
- History of substance abuse within the last 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Anhui Medical University
Hefei, Anhui, 230032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of medical psychological department, Anhui Medical University
Study Record Dates
First Submitted
August 14, 2024
First Posted
August 21, 2024
Study Start
March 1, 2024
Primary Completion
March 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
August 21, 2024
Record last verified: 2024-08