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

University of Sao Paulo

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease; Apathy

Treatments: Device: Transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01481558

0679/11

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

1. Clinical instability
2. Epilepsy
3. Metallic clip in the head
4. Use of alcohol and psychotropic drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Sham tDCS

Sham Comparator group

Description:

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

Treatment:

Device: Transcranial direct current stimulation

Transcranial direct current stimulation

Experimental group

Description:

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

Treatment:

Device: Transcranial direct current stimulation