NCT01481558

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

January 9, 2014

Completed
Last Updated

January 9, 2014

Status Verified

December 1, 2013

Enrollment Period

4 months

First QC Date

November 21, 2011

Results QC Date

March 20, 2013

Last Update Submit

December 9, 2013

Conditions

ApathyAlzheimer's Disease

Keywords

ApathyAlzheimer's DiseaseDementia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Sham tDCS

SHAM COMPARATOR

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

Device: Transcranial direct current stimulation

Transcranial direct current stimulation

EXPERIMENTAL

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

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulationDEVICE

tDCS 2 mA, dorsolateral pre-frontal cortex

Sham tDCSTranscranial direct current stimulation

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo Medical School

São Paulo, São Paulo, 01246903, Brazil

Location

Related Publications (1)

  • Suemoto CK, Apolinario D, Nakamura-Palacios EM, Lopes L, Leite RE, Sales MC, Nitrini R, Brucki SM, Morillo LS, Magaldi RM, Fregni F. Effects of a non-focal plasticity protocol on apathy in moderate Alzheimer's disease: a randomized, double-blind, sham-controlled trial. Brain Stimul. 2014 Mar-Apr;7(2):308-13. doi: 10.1016/j.brs.2013.10.003. Epub 2013 Oct 25.

    PMID: 24262299DERIVED

MeSH Terms

Conditions

LethargyAlzheimer DiseaseDementia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Results Point of Contact

Title
Claudia Kimie Suemoto
Organization
University of Sao Paulo
cksuemoto@usp.br
551130618249

Study Officials

  • Felipe Fregni, MD, PhD, MPH

    Harvard Medical School (HMS and HSDM)

    STUDY DIRECTOR

  • Ricardo Nitrini, MD, PhD

    University of Sao Paulo

    STUDY CHAIR

  • Claudia K Suemoto, MD, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Ester Nakamura-Palacios, MD, PhD

    Federal University of Espirito Santo

    STUDY CHAIR

  • Daniel Apolinário, MD

    University of Sao Paulo

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 21, 2011

First Posted

November 29, 2011

Study Start

January 1, 2012

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

January 9, 2014

Results First Posted

January 9, 2014

Record last verified: 2013-12

Locations

BR(1)