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

Study Overview
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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.

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.

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

Conditions
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Apathy, Alzheimer's Disease

Intervention / Treatment
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* Device: Transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham tDCS<br>sham-tDCS application every 2 days for 2 weeks (total of 6 applications) | Device: Transcranial direct current stimulation<br>* tDCS 2 mA, dorsolateral pre-frontal cortex<br>|
| Experimental: Transcranial direct current stimulation<br>tDCS application every 2 days for 2 weeks (total of 6 applications) | Device: Transcranial direct current stimulation<br>* tDCS 2 mA, dorsolateral pre-frontal cortex<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apathy, Alzheimer's Disease, Dementia