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

Alzheimer's Disease Clinical Trial

Official title:

Effects of Transcranial Direct Current Stimulation on the Apathy of Alzheimer's: a Randomized, Sham-controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01481558
• Other study ID #: 0679/11
• Status: Completed
• Phase: Phase 2
• First received: November 21, 2011
• Last updated: December 9, 2013
• Start date: January 2012
• Est. completion date: May 2012

Study information

• Verified date: December 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Apathy

Intervention

Device:
• Transcranial direct current stimulation
tDCS 2 mA, dorsolateral pre-frontal cortex

Locations

Country	Name	City	State
Brazil	University of São Paulo Medical School	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apathy Symptoms	Apathy evaluated by Apathy Scale by Starsktein et al, 1992, which consists of 14 items phrased as questions that are to be answered by the caregiver on a four-point Likert scale. The total score range from 0 to 42, with higher scores indicating greater apathy severity. Apathy was assessed at baseline and at the end of the sixth session (second week).	Differences in outcome measure comparing second week to baseline	No