Alzheimer's Disease, Apathy
Conditions
Keywords
Apathy, Alzheimer's Disease, Dementia
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.
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.
Interventions
DEVICETranscranial direct current stimulation
tDCS 2 mA, dorsolateral pre-frontal cortex
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Dementia defined by DSM-IV (Diagnostic and Statistical Manual version IV) 2. 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) 3. Mini Mental State Examination scores from 10 to 20 4. Apathy defined by a score equal or higher to 14 in Apathy Scale
Exclusion criteria
1. Clinical instability 2. Epilepsy 3. Metallic clip in the head 4. Use of alcohol and psychotropic drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apathy Symptoms | 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). |
Countries
Brazil
Participant flow
Recruitment details
Dates of recruitment: January 2012 to May 2012 Location: Outpatient dementia clinic
Participants by arm
| Arm | Count |
|---|---|
| Sham Transcranial Direct Current Stimulation One application of sham tDCS every two days (total: 6 applications) | 20 |
| Transcranial Direct Current Stimulation One application of tDCS every two days (total: 6 applications) | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Transcranial Direct Current Stimulation | Sham Transcranial Direct Current Stimulation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 19 Participants | 19 Participants | 38 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Continuous | 79.4 years STANDARD_DEVIATION 7.1 | 81.6 years STANDARD_DEVIATION 8 | 80.5 years STANDARD_DEVIATION 7.5 |
| Region of Enrollment Brazil | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 15 Participants | 13 Participants | 28 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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).
Time frame: Differences in outcome measure comparing second week to baseline
Population: alpha=5%, power=80%, SD estimated at 8 on Apathy scale scores, and correlation coefficient estimated at 0.7, a sample with 20 participants per arm is required to detect a between-group effect size of 0.5.~Intention to treat (ITT) analyses were conducted using the method of last observation carried forward (LOCF) for missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sham Transcranial Direct Current Stimulation | Apathy Symptoms | -2.05 units on a scale |
| Transcranial Direct Current Stimulation | Apathy Symptoms | -1.95 units on a scale |
p-value: 0.55ANCOVA