Effect of Transcranial Alternating Current Stimulation(tACS) for Early Alzheimer's Disease

NCT ID: NCT06565143

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-07-01

Brief Summary

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To investigate the clinical effect neural mechanism of transcranial alternating current stimulation in early Alzheimer's disease

Detailed Description

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Upon meeting the inclusion criteria and providing informed consent, each participant will complete a series of cognitive assessments and tACS at the First Affiliated Hospital of Anhui medical university. Patients were randomly allocated to tACS group and the sham group. There are about 20 patients in each group. For the all patients, allocation was by coin toss. Patients were studied using a double-blind design. Study participants and all personnel responsible for the clinical care of the patient remained masked to allocated condition and allocation parameters. Only tACS administrators had access to the randomization list; they had minimal contact with the patients, and no role in cognitive and symptom assessments. Each patient would be treated for continuous 14 days by tACS.

Before the tACS treatment, a series of cognitive assessments and neuropsychological tests were obtained by a trained investigator to assess baseline. Each assessment will involve a set of assessment tools, the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) as the primary outcome measure and various other tasks and questionnaires to measure cognition (including MoCA,MMSE, DS, Stroop test, TMT, BNT-30, VFT, CDT,JLOT. Form H,HVOT), memory (CAVLT, LMT), emotion(HAMA-17,HAMD-14,GDS-30), behavioral and psychological symptoms(NPI), and treatment tolerability. All the tests are conducted in two days. The patient received resting EEG data collection. After the last treatment, the MoCA, and associative memory were obtained, as well as the Global Index of Safety to assess adverse events of the treatment. Patients were instructed to focus their answers on the past 14 days. The patients had also receiving a battery measure of neuropsychological tests, resting EEG. Two months after the last treatment, participants were interviewed to obtain the same assessment as before. They were instructed to focus their answers on the past months.

Conditions

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Transcranial Alternating Current Stimulation Electroencephalography Early Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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transcranial alternating current stimulation-Real

Participants will receive real tACS once daily for 14 days

Group Type ACTIVE_COMPARATOR

Transcranial alternating current stimulation

Intervention Type DEVICE

Transcranial alternating current stimulation (tACS) is a non-invasive brain stimulation tool that alters cortical excitability and activity via application of weak alternating currents.

transcranial alternating current stimulation-Sham

Participants will receive sham tACS once daily for 14 days

Group Type SHAM_COMPARATOR

Sham transcranial alternating current stimulation

Intervention Type DEVICE

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.

Interventions

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Transcranial alternating current stimulation

Transcranial alternating current stimulation (tACS) is a non-invasive brain stimulation tool that alters cortical excitability and activity via application of weak alternating currents.

Intervention Type DEVICE

Sham transcranial alternating current stimulation

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subject diagnosed with early Alzheimer's disease or related diseases according to NIA-AA criteria.
2. Subjects must have a MMSE score between 10 and 27,indicating mild cognitive impairment or dementia.
3. CDR score ≤ 2.
4. Subject under treatment by IAChE for at least 3 months.
5. psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months.

Exclusion Criteria

1. CDR \> 2
2. Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).
3. History of head injury,stroke,or other neurologic disease.
4. Organic brain defects on T1 or T2 images.
5. History of seizures or unexplained loss of consciousness.
6. Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator.
7. Family history of medication refractory epilepsy.
8. History of substance abuse within the last 6 months.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anhui Medical University

OTHER

Sponsor Role lead

Responsible Party

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WANG KAI

Director of medical psychological department, Anhui Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Anhui Medical University

Hefei, Anhui, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kai Wang, PhD

Role: CONTACT

+86-0551-62922263 ext. +86

Xingqi Wu, M.D.

Role: CONTACT

18788836237 ext. +86

Facility Contacts

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Xingqi Wu, M.D.

Role: primary

+8618788836237 ext. +86

Miao Fang

Role: backup

+8617778381505 ext. +86

Other Identifiers

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AHMU-TACS-AD

Identifier Type: -

Identifier Source: org_study_id

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