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Transcranial Direct Current Stimulation for Depression in Alzheimer's Disease Patient - Preliminary Research (ADAPT)

Primary Purpose

Alzheimer Disease, Depression

Status
Terminated
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sham Stimulation
Sponsored by
National Center of Neurology and Psychiatry, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's disease, Depressive symptoms, Neuropsychiatric symptoms, Behavioral and Psychological Symptoms of Dementia, Neuromodulation, Transcranial Direct Current Stimulation

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participants who meets criteria of probable Alzheimer's disease defined by NINCDS-ADRDA research criteria.
  2. Participants who meets criteria of depression in Alzheimers defined by NIMH criteria.
  3. Participants who have been on fixed dose (including participants without any prescription) of antidepressants for at least two weeks on the screening visit.
  4. Participants who have been on fixed dose (including participants not prescribed) of antidementia drugs (donepezil, rivastigmine, galantamine, and memantine) for at least for weeks on the screening visit.
  5. Ambulatory participants with or without any aiding device
  6. Participants who have one caregiver, who must live with the patient at least ten hours a week and must report the patient's behavior.
  7. A study partner who can report how the participant is doing is needed.
  8. Eligible family member must sign and give consent on behalf of participants, whereas participants can give assent.

Exclusion Criteria: Following potential participants will be excluded

  1. In case their cognitive deficits are better explained by another disease (e.g., cerebral infarction, Parkinson disease, multiple sclerosis, normotensive hydrocephalus).
  2. In case they have history of epilepsy
  3. In case they need treatment by antipsychotics due to significant psychotic symptoms
  4. In case they have urgent risk of suicide or severe depression and any doctor require their hospitalization to psychiatric units.
  5. In case they have history of ineffectiveness with electroconvulsive therapy (ECT) or transcranial direct current stimulation (tDCS)
  6. In case ECT or tDCS is clinically contraindicated
  7. In case they are taking benzodiazepines or antiepileptic drugs on the screening visit
  8. In case they scored less than ten on Mini Mental State Exam (MMSE) or scored 3 or more on Clinical Dementia Rating (CDR)
  9. In case his/her GDS score is lower than 6 at baseline
  10. In case he/she is unable to agree video recording on evaluation interview

Sites / Locations

  • National Center of Neurology and Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active stimulation

Sham stimulation

Arm Description

Duration: 30 minutes Intensity: 2 mA Placement: left dorsolateral prefrontal cortex and right supraorbital area Size of electrodes: 5 cm x 7 cm Frequency: 5 days a week for three weeks

Duration: 30 minutes Intensity: 2 mA Placement: left dorsolateral prefrontal cortex and right supraorbital area Size of electrodes: 5 cm x 7 cm Frequency: 5 days a week for three weeks

Outcomes

Primary Outcome Measures

Attrition rate due to any adverse event

Secondary Outcome Measures

Rate of adverse events related to tDCS procedure
Geriatric Depression Scale
a subjective scale for depressive symptoms
Cornell Scale for Depression in Dementia
a objective scale for depressive symptoms
Neuropsychiatric Inventory
a objective scale for neuropsychiatric symptoms
Zarit Burden Interview
a subjective scale for caregivers' burden
Clinical Global Impression of Improvement
Clinician-rated impression of improvement
Starkstein Apathy Scale
a subjective scale for apathy

Full Information

First Posted
January 27, 2015
Last Updated
February 24, 2020
Sponsor
National Center of Neurology and Psychiatry, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT02351388
Brief Title
Transcranial Direct Current Stimulation for Depression in Alzheimer's Disease Patient - Preliminary Research
Acronym
ADAPT
Official Title
Ameliorating Depression in Alzheimer's Disease Patients by Transcranial Direct Current Stimulation (ADAPT) - Preliminary Research
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
failure to recruit enough number of participants
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
March 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Center of Neurology and Psychiatry, Japan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This project will investigate the safety and efficacy of transcranial direct current stimulation (tDCS) in the treatment of depression among patients with Alzheimer's disease. The investigators aim to ameliorate depressive symptoms among patient with Alzheimer's disease, by anodal stimulation on left dorsolateral prefrontal cortex and cathodal suppression on right supraorbital area. Active stimulation will be compare to sham condition in 20 patients (10 in each groups).
Detailed Description
This project will investigate the safety and efficacy of transcranial direct current stimulation (tDCS) in the treatment of depression among patients with Alzheimer's disease. tDCS causes an excitatory effect on the anode side and suppressing effect on the cathode side through sculp with very week currents (2 mA in this project). The investigators aim to ameliorate depressive symptoms among patient with Alzheimer's disease, by anodal stimulation on left dorsolateral prefrontal cortex and cathodal suppression on right supraorbital area. Active stimulation will be compare to sham condition in 20 patients (10 in each groups) from outpatient clinic in National Center of Neurology and Psychiatry, Japan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Depression
Keywords
Alzheimer's disease, Depressive symptoms, Neuropsychiatric symptoms, Behavioral and Psychological Symptoms of Dementia, Neuromodulation, Transcranial Direct Current Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active stimulation
Arm Type
Active Comparator
Arm Description
Duration: 30 minutes Intensity: 2 mA Placement: left dorsolateral prefrontal cortex and right supraorbital area Size of electrodes: 5 cm x 7 cm Frequency: 5 days a week for three weeks
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
Duration: 30 minutes Intensity: 2 mA Placement: left dorsolateral prefrontal cortex and right supraorbital area Size of electrodes: 5 cm x 7 cm Frequency: 5 days a week for three weeks
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Intervention Type
Other
Intervention Name(s)
Sham Stimulation
Primary Outcome Measure Information:
Title
Attrition rate due to any adverse event
Time Frame
three weeks
Secondary Outcome Measure Information:
Title
Rate of adverse events related to tDCS procedure
Time Frame
three weeks
Title
Geriatric Depression Scale
Description
a subjective scale for depressive symptoms
Time Frame
one week, two weeks, three weeks, five weeks (followup)
Title
Cornell Scale for Depression in Dementia
Description
a objective scale for depressive symptoms
Time Frame
two weeks, three weeks, five weeks (followup)
Title
Neuropsychiatric Inventory
Description
a objective scale for neuropsychiatric symptoms
Time Frame
three weeks, five weeks (followup)
Title
Zarit Burden Interview
Description
a subjective scale for caregivers' burden
Time Frame
three weeks, five weeks (followup)
Title
Clinical Global Impression of Improvement
Description
Clinician-rated impression of improvement
Time Frame
one, two, three and five weeks (followup)
Title
Starkstein Apathy Scale
Description
a subjective scale for apathy
Time Frame
two, three and five weeks (followup)
Other Pre-specified Outcome Measures:
Title
Clinical Dementia Rating
Description
severity of dementia
Time Frame
baseline
Title
Quality of Life - Alzheimer's Disease
Description
a QoL scale
Time Frame
baseline
Title
ADCS-ADL
Description
Alzheimer's Disease Co-operative Study - Activity of Daily Living
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants who meets criteria of probable Alzheimer's disease defined by NINCDS-ADRDA research criteria. Participants who meets criteria of depression in Alzheimers defined by NIMH criteria. Participants who have been on fixed dose (including participants without any prescription) of antidepressants for at least two weeks on the screening visit. Participants who have been on fixed dose (including participants not prescribed) of antidementia drugs (donepezil, rivastigmine, galantamine, and memantine) for at least for weeks on the screening visit. Ambulatory participants with or without any aiding device Participants who have one caregiver, who must live with the patient at least ten hours a week and must report the patient's behavior. A study partner who can report how the participant is doing is needed. Eligible family member must sign and give consent on behalf of participants, whereas participants can give assent. Exclusion Criteria: Following potential participants will be excluded In case their cognitive deficits are better explained by another disease (e.g., cerebral infarction, Parkinson disease, multiple sclerosis, normotensive hydrocephalus). In case they have history of epilepsy In case they need treatment by antipsychotics due to significant psychotic symptoms In case they have urgent risk of suicide or severe depression and any doctor require their hospitalization to psychiatric units. In case they have history of ineffectiveness with electroconvulsive therapy (ECT) or transcranial direct current stimulation (tDCS) In case ECT or tDCS is clinically contraindicated In case they are taking benzodiazepines or antiepileptic drugs on the screening visit In case they scored less than ten on Mini Mental State Exam (MMSE) or scored 3 or more on Clinical Dementia Rating (CDR) In case his/her GDS score is lower than 6 at baseline In case he/she is unable to agree video recording on evaluation interview
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuma Yokoi, MD
Organizational Affiliation
National Center of Neurology and Psychiatry, Japan
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Center of Neurology and Psychiatry
City
Kodaira
State/Province
Tokyo
ZIP/Postal Code
187-8551
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
28629447
Citation
Narita Z, Yokoi Y. Transcranial direct current stimulation for depression in Alzheimer's disease: study protocol for a randomized controlled trial. Trials. 2017 Jun 19;18(1):285. doi: 10.1186/s13063-017-2019-z.
Results Reference
derived
Links:
URL
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000016938&language=J
Description
UMIN CTR database

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Transcranial Direct Current Stimulation for Depression in Alzheimer's Disease Patient - Preliminary Research

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