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

February 24, 2020 updated by: National Center of Neurology and Psychiatry, Japan

Ameliorating Depression in Alzheimer's Disease Patients by Transcranial Direct Current Stimulation (ADAPT) - Preliminary Research

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Kodaira, Tokyo, Japan, 187-8551
        • National Center of Neurology and Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active stimulation
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
Device: Transcranial Direct Current Stimulation
Sham Comparator: Sham stimulation
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
Other: Sham Stimulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Attrition rate due to any adverse event
Time Frame: three weeks
three weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of adverse events related to tDCS procedure
Time Frame: three weeks
three weeks
Geriatric Depression Scale
Time Frame: one week, two weeks, three weeks, five weeks (followup)
a subjective scale for depressive symptoms
one week, two weeks, three weeks, five weeks (followup)
Cornell Scale for Depression in Dementia
Time Frame: two weeks, three weeks, five weeks (followup)
a objective scale for depressive symptoms
two weeks, three weeks, five weeks (followup)
Neuropsychiatric Inventory
Time Frame: three weeks, five weeks (followup)
a objective scale for neuropsychiatric symptoms
three weeks, five weeks (followup)
Zarit Burden Interview
Time Frame: three weeks, five weeks (followup)
a subjective scale for caregivers' burden
three weeks, five weeks (followup)
Clinical Global Impression of Improvement
Time Frame: one, two, three and five weeks (followup)
Clinician-rated impression of improvement
one, two, three and five weeks (followup)
Starkstein Apathy Scale
Time Frame: two, three and five weeks (followup)
a subjective scale for apathy
two, three and five weeks (followup)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Dementia Rating
Time Frame: baseline
severity of dementia
baseline
Quality of Life - Alzheimer's Disease
Time Frame: baseline
a QoL scale
baseline
ADCS-ADL
Time Frame: baseline
Alzheimer's Disease Co-operative Study - Activity of Daily Living
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Center of Neurology and Psychiatry, Japan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yuma Yokoi, MD, National Center of Neurology and Psychiatry, Japan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 26, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A2014-086

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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