Phase 2
N=40
Effects of Transcranial Direct Current Stimulation on the Apathy of Alzheimer's Disease
Apathy · Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01481558 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Apathy Symptoms — -2.05; -1.95 units on a scale — p=0.55
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Transcranial direct current stimulation (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Sao Paulo
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apathy Symptoms |
-2.05; -1.95 | 0.55 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01481558). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.