A Pilot Study for the Improvement of Cognitive Function (ADAS-Cog 11) After Transcranial Direct Current Stimulation in Mild to Moderate Alzheimer's Disease

Samsung Medical Center1 site in 1 country20 target enrollmentAugust 2014

ConditionsAlzheimer's Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Alzheimer's Disease
Sponsor: Samsung Medical Center
Enrollment: 20
Locations: 1
Primary Endpoint: Change in cognitive function
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this preliminary study is to investigate whether the transcranial direct current stimulation (tDCS) improves the cognitive function in patients with Alzheimer's disease

Detailed Description

Twenty patients were recruited and randomized to receive either real or sham-tDCS over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Their legally responsible caregivers were provided with mobile tDCS device, and were instructed to use it on the patients at home. 30-minute session of the stimulation were applied everyday in the morning for 12 weeks. The patients were evaluated at baseline, at week 6 and 12.

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

December 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Samsung Medical Center

Responsible Party

Principal Investigator

Duk Lyul Na

Professor of Neurology, Sungkyunkwan University School of Medicine

Samsung Medical Center

Eligibility Criteria

Inclusion Criteria

•Subjects who have Korean version of Mini Mental Status Examination score 10 to 24
•Subjects who have SVLT and RCFT delayed recall test scores lower than 1.5SD
•Subjects who have had other cognitive impairments besides memory
•Subjects who have Seoul-Instrumental Activities of Daily Living score (S-IADL) of 8 or more.
•Subjects who are only dementia of Alzheimer's type
•Subjects who are right-handed
•Subjects who are able to read and write
•Both patient and legally responsible caregiver has provided informed consent
•According to the latest MRI result, periventricular white matter cap or band is less than 10mm, or the deep white matter hyper-intensity is less than 25 mm

Exclusion Criteria

•Subjects who have a history of stroke and seizures
•Subjects who have any illnesses that may disturb the patients completing the trials, including stroke, Parkinson's disease, type 1 diabetes, uncontrollable high blood pressure, Huntington's disease, cerebral palsy, liver failure, nephritis, encephalitis, meningitis, scleroma, seizures and a transient ischemic attack.
•Subjects who have a History of DSM-IV Axis I disorders
•Subjects who have neurologic problems on physical examination that cause memory disturbances
•Subjects who have Extremely sensitive skin
•Subjects who have suffered from the cancer in 3 years
•Subjects who have had a cerebrovascular neurosurgery in medical history
•Subjects who have dyspnea in sitting position
•Subjects who have problems with memory, language and problem-solving for 2 hours after the heart attack.
•Subjects who have a history of drug or alcohol abuse (in the past 5 years)

Outcomes

Primary Outcomes

Change in cognitive function

Time Frame: from baseline to Week 6 and Week 12

Measured by ADAS-Cog 11

Secondary Outcomes

Change in questionnaire(from baseline to Week 12)
Change in Korean version of Geriatric Depression Scale (K-GDS)(from baseline to Week 6 and Week 12)
Change in tDCS feedback(Week 2, 4, 6 and 12)
Change in cognitive function(from baseline to Week 6 and Week 12)
Change in activities of daily living(from baseline to Week 12)
Change in behavioral symptoms(from baseline to Week 6 and Week 12)
Change in Clinician's Interview-Based Impression of Change Plus (CIBIC plus)(from baseline to Week 12)