ApathyPhase 2NCT01481558
Effects of Transcranial Direct Current Stimulation on the Apathy of Alzheimer's Disease
A Phase 2 study testing Transcranial direct current stimulation in people with Apathy and Alzheimer's Disease, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Apathy, Alzheimer's Disease
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to May 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Clinical instability
- Epilepsy
- Metallic clip in the head
- Use of alcohol and psychotropic drugs
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo Medical School
São Paulo, São Paulo, 01246903
About this study
Official title: Effects of Transcranial Direct Current Stimulation on the Apathy of Alzheimer's: a Randomized, Sham-controlled Clinical Trial
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.
Read the detailed 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.
- Conditions
- Apathy, Alzheimer's Disease
- Being tested
- Transcranial direct current stimulation
- Keywords
- Apathy, Alzheimer's Disease, Dementia
- Medical subject headings
- Lethargy, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
tDCS 2 mA, dorsolateral pre-frontal cortex
| Study group | Role | What they receive |
|---|---|---|
| Sham tDCS | Sham comparator | sham-tDCS application every 2 days for 2 weeks (total of 6 applications) Receives: Device: Transcranial direct current stimulation |
| Transcranial direct current stimulation | Experimental | tDCS application every 2 days for 2 weeks (total of 6 applications) Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Differences in outcome measure comparing second week to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ApathyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Kimie Suemoto, University of Sao Paulo
- Investigators
- Felipe Fregni, MD, PhD, MPH, Study director, Harvard Medical School (HMS and HSDM)Ricardo Nitrini, MD, PhD, Study chair, University of Sao PauloClaudia K Suemoto, MD, PhD, Principal investigator, University of Sao PauloEster Nakamura-Palacios, MD, PhD, Study chair, Federal University of Espirito SantoDaniel Apolinário, MD, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481558
- Sponsor's protocol ID
- 0679/11
- Status last verified
- Dec 2013
- First submitted
- 21 Nov 2011
- Last updated
- 9 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 24262299
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation on the Apathy of Alzheimer's: a Randomized, Sham-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01481558
- Acronym / sponsor ID
- 0679/11
- Conditions
- Apathy, Alzheimer's Disease
- Keywords
- Apathy, Alzheimer's Disease, Dementia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Posted 9 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham tDCS | Sham comparator | Device: Transcranial direct current stimulationsham-tDCS application every 2 days for 2 weeks (total of 6 applications) |
| Transcranial direct current stimulation | Experimental | Device: Transcranial direct current stimulationtDCS application every 2 days for 2 weeks (total of 6 applications) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Clinical instability
- Epilepsy
- Metallic clip in the head
- Use of alcohol and psychotropic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulationtDCS 2 mA, dorsolateral pre-frontal cortex | Device | Sham tDCS, Transcranial direct current stimulation |
Primary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24262299Suemoto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felipe Fregni, MD, PhD, MPH study director
Harvard Medical School (HMS and HSDM)
Ricardo Nitrini, MD, PhD study chair
University of Sao Paulo
Claudia K Suemoto, MD, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transcranial direct current stimulation in people with Apathy and Alzheimer's Disease, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apathy Symptoms (time frame: Differences in outcome measure comparing second week to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01481558, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2014.