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Trial Outcomes & Findings for Effects of Transcranial Direct Current Stimulation on the Apathy of Alzheimer's Disease (NCT NCT01481558)

NCT ID: NCT01481558

Last Updated: 2014-01-09

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Differences in outcome measure comparing second week to baseline

Results posted on

2014-01-09

Participant Flow

Dates of recruitment: January 2012 to May 2012 Location: Outpatient dementia clinic

Participant milestones

Participant milestones
Measure
Sham Transcranial Direct Current Stimulation
One application of sham tDCS every two days (total: 6 applications)
Transcranial Direct Current Stimulation
One application of tDCS every two days (total: 6 applications)
Overall Study
STARTED
20
20
Overall Study
COMPLETED
20
20
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sham Transcranial Direct Current Stimulation
n=20 Participants
One application of sham tDCS every two days (total: 6 applications)
Transcranial Direct Current Stimulation
n=20 Participants
One application of tDCS every two days (total: 6 applications)
Total
n=40 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Age, Categorical
>=65 years
19 Participants
n=5 Participants
19 Participants
n=7 Participants
38 Participants
n=5 Participants
Age, Continuous
81.6 years
STANDARD_DEVIATION 8.0 • n=5 Participants
79.4 years
STANDARD_DEVIATION 7.1 • n=7 Participants
80.5 years
STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male
Female
13 Participants
n=5 Participants
15 Participants
n=7 Participants
28 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
5 Participants
n=7 Participants
12 Participants
n=5 Participants
Region of Enrollment
Brazil
20 participants
n=5 Participants
20 participants
n=7 Participants
40 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure
Sham Transcranial Direct Current Stimulation
n=20 Participants
One application of sham tDCS every two days (total: 6 applications)
Transcranial Direct Current Stimulation
n=20 Participants
One application of tDCS every two days (total: 6 applications)
Apathy Symptoms
-2.05 units on a scale
Interval -3.68 to -0.42
-1.95 units on a scale
Interval -3.49 to -0.41

Adverse Events

Sham Transcranial Direct Current Stimulation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Transcranial Direct Current Stimulation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Claudia Kimie Suemoto

University of Sao Paulo

Phone: 551130618249

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place