The Treatment of High Intensity Transcranial Current Stimulation for Alzheimer's Disease

NCT06380725 | Not Yet Recruiting FDA Device

• 1 other identifier: jshim8zay6vd
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Alzheimer's disease (AD) is a neurodegenerative disorder characterized by progressive cognitive dysfunction and behavioral impairment. It is currently the most common type of dementia in the old age. At present, the clinical treatment of Alzheimer's disease is expensive and has side effects, so it is very important to explore new methods of treatment for AD. Investigators designed a prospective, randomized, double-blinded and placebo-controlled trial to investigate the effect of transcranial alternating current stimulation (tACS) on cognitive function in AD patients and to assess the biological effectiveness of the treatment.

Conditions

Alzheimer's Disease; Mild Cognitive Impairment; Dementia

Keywords

Alzheimer's Disease; biomarker; Transcranial alternating current stimulation; functional connectivity; Brain network

Outcome Measures

Primary Outcomes (3)

• Cognitive appraisal

  A series of cognitive functions such as verbal function and visuospatial functions will be evaluated by Clock drawing test (maximum score =4, minimum score =0, the higher the better) and Boston Naming Test (maximum score =30, minimum score =0, the higher the better) ect.

  A total of 5 times will be measured, before the treatment, immediately after the treatment, 1-, 3- and 6-month follow-ups.

• Global Cognitive appraisal

  Overall cognitive function will be assessed through Clinical Dementia Rating(maximum score =3, minimum score =0, the higher the better) and Minimum Mental State Examination(maximum score =30, minimum score =0, the higher the better) ect.

  A total of 5 times will be measured, before the treatment, immediately after the treatment, 1-, 3- and 6-month follow-ups.

• Psychobehavioral assessment

  The mental and behavioral states of the patients will be evaluated by Neuropsychiatric Inventory(maximum score =144, minimum score =0, the lower the better) and Hamilton's Depression Scale (maximum score =68, minimum score =0, the lower the better) ect.

  A total of 5 times will be measured, before the treatment, immediately after the treatment, 1-, 3- and 6-month follow-ups.

Secondary Outcomes (5)

• Near-infrared spectroscopy

  A total of 5 times will be measured, before the treatment, immediately after the treatment, 1-, 3- and 6-month follow-ups.

• Event related potential measurement

  A total of 5 times will be measured, before the treatment, immediately after the treatment, 1-, 3- and 6-month follow-ups.

• Peripheral blood biomarkers

  A total of 5 times will be measured, before the treatment, immediately after the treatment, 1-, 3- and 6-month follow-ups.

• Magnetic Resonance Imaging

  A total of 3 measurements, before treatment, immediately after treatment, 1 month follow-up

• Incidence of side effects

  Interviews will be conducted daily after treatment and once at 1-, 3- and 6-month follow-ups.

Study Arms (2)

control group

PLACEBO COMPARATOR

Subjects sit comfortably in a recliner and receive FDA-approved transcranial alternating current stimulation (sham stimulation) with trained operators following standardized instructions. Subjects are advised to relax, drink water, and even sleep, and not communicate with the operator as much as possible.

Device: Transcranial alternating current stimulation(sham stimulation)

treatment group

EXPERIMENTAL

Subjects sit comfortably in a recliner and receive FDA-approved transcranial alternating current stimulation (real stimulation) with trained operators following standardized instructions. Subjects are advised to relax, drink water, and even sleep, and not communicate with the operator as much as possible.

Device: Transcranial alternating current stimulation(real stimulation)

Interventions

Transcranial alternating current stimulation(real stimulation) DEVICE

Real tACS is an emerging noninvasive neuro-regulation technique that applies a specific frequency of stimulation and a specific intensity of weak current to the brain by means of electrodes placed in the skull.

treatment group

Transcranial alternating current stimulation(sham stimulation) DEVICE

Transcranial alternating current stimulation (sham-stimulation) is an emerging noninvasive neuro-regulation technique that applies a specific frequency of stimulation and a specific intensity of a weak current to the brain by means of electrodes placed in the skull. The subjects felt the same as the real stimulus when receiving the sham-stimulus treatment, but the sham-stimulus did not have the current stimulation.

control group

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the diagnostic criteria of National Institute on Aging and Alzheimer's Association (NIA-AA) 2011 for Alzheimer's disease, Clinical Dementia Rating (CDR) score is greater than or equal to 0.5 and less than or equal to 1, and amyloid PET imaging is positive.
• Have the ability to cooperate with neuropsychological testing, EEG measurement, and MRI examination;
• Have willingness to undergo cognitive psychological evaluation;
• Do not have cognitive impairment due to other degenerative diseases or viral and immune encephalitis;
• The length of schooling is at least 3 years.

You may not qualify if:

• Do not suffer from severe depression, anxiety and other mental illness;
• Do not suffer from major diseases such as tumors, heart and lung diseases, nervous system diseases, etc.
• Do not have been diagnosed with other dementia such as Parkinson's disease dementia (PDD), frontotemporal dementia (FTD), lewy body dementia (DLB), and normal cranial pressure hydrocephalus (NPH).

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Jiong Shi, doctor

  The First Affiliated Hospital of University of Science and Technology of China

  STUDY CHAIR

Central Study Contacts

Jiong Shi, doctor

CONTACT

0551-62284377; jshi2022@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Investigators designed a double-blinded trial in which neither the investigator nor the subjects know whether they will be received the treatment or a placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Principal Investigator, Clinical Professor

Model Details: Investigators designed a randomized double-blinded placebo-controlled trial by randomly dividing subjects into two groups: one is the treatment group and the other is the placebo group.

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 24, 2024
• Study Start: April 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the research is published in an academic journal, a link to the laboratory website will be provided in the article.
• Access Criteria: Access to the data requires the consent of the principal investigator and the ethics committee.