Effects of Transcranial Direct Current Stimulation on the Apathy of Alzheimer's Disease

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-05-31

Brief Summary

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This is a phase 2 double-blind, randomized, sham-controlled study to investigate the effects of repeated transcranial direct current stimulation for the treatment of apathy in moderate Alzheimer's Disease in patients selected from an outpatient clinics in São Paulo, Brazil.

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Detailed Description

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Forty patients were randomized to receive either active or sham-tDCS over the left dorsolateral prefrontal cortex (DLPFC). Patients received six sessions of intervention during two weeks and were evaluated at baseline, at week one and two, and after one week without intervention. Clinical raters, patients, and caregivers were blinded. The primary outcome was apathy. Global cognition and neuropsychiatric symptoms were examined as secondary outcomes.

Conditions

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Apathy Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Sham tDCS

sham-tDCS application every 2 days for 2 weeks (total of 6 applications)

Group Type SHAM_COMPARATOR

Transcranial direct current stimulation

Intervention Type DEVICE

tDCS 2 mA, dorsolateral pre-frontal cortex

Transcranial direct current stimulation

tDCS application every 2 days for 2 weeks (total of 6 applications)

Group Type EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type DEVICE

tDCS 2 mA, dorsolateral pre-frontal cortex

Interventions

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Transcranial direct current stimulation

tDCS 2 mA, dorsolateral pre-frontal cortex

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Dementia defined by DSM-IV (Diagnostic and Statistical Manual version IV)
2. Possible Alzheimer's Disease defined by NINCDS-ADRDA (National Institute for Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association)
3. Mini Mental State Examination scores from 10 to 20
4. Apathy defined by a score equal or higher to 14 in Apathy Scale