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

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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Key information

Conditions

Apathy Alzheimer Disease Alzheimer's Disease Brain Diseases Central Nervous System Diseases Dementia Lethargy Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of São Paulo Medical School

São Paulo, 01246903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Dementia defined by DSM-IV (Diagnostic and Statistical Manual version IV)
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)
Mini Mental State Examination scores from 10 to 20
Apathy defined by a score equal or higher to 14 in Apathy Scale

Exclusion criteria

Clinical instability
Epilepsy
Metallic clip in the head
Use of alcohol and psychotropic drugs

Treatment and study plan

Transcranial Direct Current Stimulation

Device

tDCS 2 mA, dorsolateral pre-frontal cortex

Primary outcomes

Apathy Symptoms

Time frame: Differences in outcome measure comparing second week to baseline

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).

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Nov 29, 2011
Registry last updated: Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed