- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02351388
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
Terminated
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
4
Phase
- 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
-
-
Tokyo
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Kodaira, Tokyo, Japan, 187-8551
- National Center of Neurology and Psychiatry
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-
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
Ages Eligible for Study
65 years to 90 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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 |
Intervention / Treatment |
---|---|
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
|
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Attrition rate due to any adverse event
Time Frame: three weeks
|
three weeks
|
Secondary Outcome Measures
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
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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)
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Clinician-rated impression of improvement
|
one, two, three and five weeks (followup)
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Starkstein Apathy Scale
Time Frame: two, three and five weeks (followup)
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a subjective scale for apathy
|
two, three and five weeks (followup)
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Other Outcome Measures
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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- 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.
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
December 1, 2014
Primary Completion (Actual)
December 31, 2017
Study Completion (Actual)
March 15, 2018
Study Registration Dates
First Submitted
January 27, 2015
First Submitted That Met QC Criteria
January 27, 2015
First Posted (Estimate)
January 30, 2015
Study Record Updates
Last Update Posted (Actual)
February 26, 2020
Last Update Submitted That Met QC Criteria
February 24, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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