Alzheimer DiseaseADAPTNCT02351388
Transcranial Direct Current Stimulation for Depression in Alzheimer's Disease Patient - Preliminary Research
A study testing Transcranial Direct Current Stimulation in people with Alzheimer Disease and Depression, run by National Center of Neurology and Psychiatry, Japan at 1 site in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Alzheimer Disease, Depression
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2014to 15 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Japan1 site
National Center of Neurology and Psychiatry
Kodaira, Tokyo, 187-8551
About this study
Official title: 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).
Read the 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.
- Conditions
- Alzheimer Disease, Depression
- Being tested
- Transcranial Direct Current Stimulation, Sham Stimulation
- Keywords
- Alzheimer's disease, Depressive symptoms, Neuropsychiatric symptoms, Behavioral and Psychological Symptoms of Dementia, Neuromodulation, Transcranial Direct Current Stimulation
- Medical subject headings
- Alzheimer Disease, Depression, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham StimulationOther
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Active comparator | 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 Receives: Device: Transcranial Direct Current Stimulation |
| Sham stimulation | Sham comparator | 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 Receives: Other: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attrition rate due to any adverse event
Measured: three weeks
Secondary outcomes (7)
Rate of adverse events related to tDCS procedure
Measured: three weeks
Geriatric Depression Scale
a subjective scale for depressive symptoms
Measured: one week, two weeks, three weeks, five weeks (followup)
Cornell Scale for Depression in Dementia
a objective scale for depressive symptoms
Measured: two weeks, three weeks, five weeks (followup)
Neuropsychiatric Inventory
a objective scale for neuropsychiatric symptoms
Measured: three weeks, five weeks (followup)
Zarit Burden Interview
a subjective scale for caregivers' burden
Measured: three weeks, five weeks (followup)
Clinical Global Impression of Improvement
Clinician-rated impression of improvement
Measured: one, two, three and five weeks (followup)
Starkstein Apathy Scale
a subjective scale for apathy
Measured: two, three and five weeks (followup)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startDec 2014
- Primary completion31 Dec 2017
- Study completion15 Mar 2018
Why it stopped: failure to recruit enough number of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center of Neurology and Psychiatry, Japan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuma Yokoi, MD, Principal investigator, National Center of Neurology and Psychiatry, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351388
- Sponsor's protocol ID
- A2014-086
- Acronym
- ADAPT
- Status last verified
- Feb 2020
- First submitted
- 27 Jan 2015
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28629447
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ameliorating Depression in Alzheimer's Disease Patients by Transcranial Direct Current Stimulation (ADAPT) - Preliminary Research
- ClinicalTrials.gov ID
- NCT02351388
- Acronym / sponsor ID
- ADAPT / A2014-086
- Conditions
- Alzheimer Disease, Depression
- Keywords
- Alzheimer's disease, Depressive symptoms, Neuropsychiatric symptoms, Behavioral and Psychological Symptoms of Dementia, Neuromodulation, Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: failure to recruit enough number of participants
- Enrolment
- 4 participants (actual)
- Lead sponsor
- National Center of Neurology and Psychiatry, JapanUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 30 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Active comparator | Device: Transcranial Direct Current StimulationDuration: 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 stimulation | Sham comparator | Other: Sham StimulationDuration: 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 |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current Stimulation | Device | Active stimulation |
| Sham Stimulation | Other | Sham stimulation |
Primary outcome
Attrition rate due to any adverse event
Time frame: three weeks
7 secondary outcomes
Rate of adverse events related to tDCS procedure
Time frame: three weeks
Geriatric Depression Scale
Time frame: one week, two weeks, three weeks, five weeks (followup)
Cornell Scale for Depression in Dementia
Time frame: two weeks, three weeks, five weeks (followup)
Neuropsychiatric Inventory
Time frame: three weeks, five weeks (followup)
Zarit Burden Interview
Time frame: three weeks, five weeks (followup)
Clinical Global Impression of Improvement
Time frame: one, two, three and five weeks (followup)
Starkstein Apathy Scale
Time frame: two, three and five weeks (followup)
Results and safety
The study was stopped early (reason given: failure to recruit enough number of participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Derived from this study: PubMed 28629447Narita 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.
- UMIN CTR databaseLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuma Yokoi, MD principal investigator
National Center of Neurology and Psychiatry, Japan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Alzheimer Disease and Depression, run by National Center of Neurology and Psychiatry, Japan at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: failure to recruit enough number of participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attrition rate due to any adverse event (time frame: three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02351388, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.