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4Hz Transcranial Alternating Current Stimulation for Patients With Mild Alzheimer's Disease

Primary Purpose

Alzheimer Disease

Status

Active

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

transcranial alternating current stimulation

sham stimulation

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects with informed consent;
45-75 years of age;
At least 6 years of education;
AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) guidelines;
Clinical Dementia Rating Scale (CDR)=1.0;
Positive findings in amyloid PET imaging or amyloid protein levels in CSF;
On a stable dose of cholinesterase inhibitors (e.g. donepezil or rivastigmine) as defined as 6 consecutive weeks of treatment at an unchanging dose, and without any intentions to modify the dosage during the observation period.

Exclusion Criteria:

Current or past history of any neurological disorder other than dementia, such as epilepsy, stroke, progressive neurologic disease (e.g. multiple sclerosis), poorly controlled migraines or intracranial brain lesions; and history of previous neurosurgery or head trauma that resulted in residual neurologic impairment;
Contraindication for undergoing MRI or receiving tACS;
Eczema or sensitive skin;
Familial AD;
Depression or other psychiatric disorders;
Abnormal brain structural magnetic resonance imaging (MRI) scan, including hydrocephalus, stroke, structural lesions, etc. that would potentially confound the outcome;
Severe cardiovascular/pulmonary disorders;
Other conditions, in the investigator's opinion, might not be suitable for the study.

Sites / Locations

Xuanwu Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

tACS group

sham stimulation group

Arm Description

NEXALIN ADI transcranial alternating current stimulator

Sham stimulator provided by NEXALIN company

Outcomes

Primary Outcome Measures

Change in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 11-items version)

ADAS-cog 11 scale ranges from 0 to 70, and higher value represents a worse outcome. This study will use ADAS-cog to assess changes in the global cognitive function after intervention.

Secondary Outcome Measures

Change in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 11-items version).

ADAS-cog 11 scale ranges from 0 to 70, and higher value represents a worse outcome. This study will use ADAS-cog to assess changes in the global cognitive function after intervention.

Change in brain volume and white matter integrity

Structural MRI will be used to measure brain volume and white matter integrity.

Change in brain connectivity

Functional MRI and resting-state EEG will be used to measure brain connectivity.

Change in Mini-mental State Examination

Mini-mental State Examination (MMSE) will be used to evaluate the general cognitive function. MMSE ranges from 0 to 30, and higher value represents a better outcome.

Change in Montreal Cognitive Assessment

Montreal Cognitive Assessment (MoCA) will be used to evaluate the general cognitive function. MoCA ranges from 0 to 30, and higher value represents a better outcome.

Change in Clinical Dementia Rating Scale sum of the boxes

Clinical Dementia Rating Scale sum of the boxes (CDR-SB) will be used to evaluate the general cognitive function. CDR-SB ranges from 0 to 18, and higher value represents a worse outcome.

Change in memory function

WHO-UCLA Auditory Verbal Learning Test will be used to assess memory function. It ranges from 0 to 45, and higher value represents a better outcome.

Change in Digit span forward

Digit span will be used to assess attention. It ranges from 3 to 10, and higher value represents a better outcome.

Change in Digit span backward

Digit span backward will be used to assess executive function. It ranges from 2 to 8, and higher value represents a better outcome.

Change in Trail Making Test

Trail-Making Test B minus A score will be used to assess executive function. Trail-Making Test B minus A ranges from -150 to 300, higher value represents a worse outcome.

Change in Boston Naming Test

Boston Naming Test will be used to assess language function. It ranges from 0 to 30, and higher value represents a better outcome.

Change in Neuropsychiatric Inventory (NPI)

The Neuropsychiatric Inventory will be used to measure neuropsychiatric symptoms. It ranges from 0 to 144, and higher value represents a worse outcome.

Change in Geriatric Depression Scale (GDS)

The Geriatric Depression Scale will be used to measure neuropsychiatric symptoms. It ranges from 0 to 30, and higher value represents a worse outcome.

Change in Activities of Daily Living

Activities of Daily Living (ADL) scale will be used to assess the change of life quality. It ranges from 20 to 80. The "20" represents normal life ability and the higher score presents the worse life ability.

Side-effects of tACS

Adverse Events as a result of tACS stimulation will be reported.

Full Information

NCT ID

NCT04088643

First Posted

September 11, 2019

Last Updated

July 12, 2022

Sponsor

Xuanwu Hospital, Beijing

1. Study Identification

Unique Protocol Identification Number

NCT04088643

Brief Title

4Hz Transcranial Alternating Current Stimulation for Patients With Mild Alzheimer's Disease

Official Title

The Efficacy of 4Hz Transcranial Alternating Current Stimulation for Patients With Mild Alzheimer's Disease: A Randomized Controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 14, 2019 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xuanwu Hospital, Beijing

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The goal of this study is to explore the efficacy and safety of 4Hz transcranial alternating current stimulation (tACS) in patients with mild Alzheimer's disease (AD). The study will recruit 40 individuals with mild AD, and the participants will be randomized to either a 4 Hz tACS group or a sham stimulation group. Both groups will undergo 30 one-hour sessions across 3 weeks (21 days). At the end of the intervention and 3-month follow-up, all subjects will repeat the baseline assessments.

Detailed Description

Background: Recently, transcranial alternating current stimulation (tACS), which could interact with ongoing neuronal activity, has emerged as a potentially effective and promising treatment for Alzheimer's disease (AD), and the 4Hz frequency was suggested to improve working memory Methods: The proposed study is a double-blinded, randomized controlled trial that will include 40 individuals with mild AD, and the participants will be randomized to either a 4Hz tACS group or a sham stimulation group. Both groups will undergo 30 one-hour sessions in 3 weeks (21 days). The outcome measures will be assessed at baseline, end of intervention and 3 months after the first session. Primary outcome is global cognitive function, assessed by the 11-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog), and the second outcomes include changes in other neuropsychological assessments, structural MRI, resting electroencephalogram (EEG) and simultaneous EEG-functional MRI (fMRI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

tACS group

Arm Type

Experimental

Arm Description

NEXALIN ADI transcranial alternating current stimulator

Arm Title

sham stimulation group

Arm Type

Sham Comparator

Arm Description

Sham stimulator provided by NEXALIN company

Intervention Type

Device

Intervention Name(s)

transcranial alternating current stimulation

Intervention Description

The alternating current is administered through medical grade conductive pads that are produced specifically for the Nexalin technology. The pads are places on the forehead and behind each ear, and are connected to the Nexalin device with thin cables. Intervention will be implemented with a tACS device with 4Hz frequency and a peak-to-peak amplitude of 15mA, 30 one-hour sessions in 3 weeks (21 days).

Intervention Type

Device

Intervention Name(s)

sham stimulation

Intervention Description

Electrodes will also be put on patient's forehead and behind each ear. The sham stimulator has the exactly same appearance with the true stimulator. Participants and operators cannot determine whether the stimulator is true based on its appearance or patients' feelings. However, when the device is started, no current flows through the electrodes. Participants in this controlled group will also receive sham stimulations with 30 one-hour sessions in 21 days.

Primary Outcome Measure Information:

Title

Change in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 11-items version)

Description

ADAS-cog 11 scale ranges from 0 to 70, and higher value represents a worse outcome. This study will use ADAS-cog to assess changes in the global cognitive function after intervention.

Time Frame

up to 21 days (end of intervention)

Secondary Outcome Measure Information:

Title

Change in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 11-items version).

Description

ADAS-cog 11 scale ranges from 0 to 70, and higher value represents a worse outcome. This study will use ADAS-cog to assess changes in the global cognitive function after intervention.

Time Frame

3 months

Title

Change in brain volume and white matter integrity

Description

Structural MRI will be used to measure brain volume and white matter integrity.

Time Frame