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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Alzheimer Disease, Depression

Intervention / Treatment
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* Device: Transcranial Direct Current Stimulation
* Other: Sham Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active stimulation<br>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<br> <br> |
| Sham Comparator: Sham stimulation<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attrition rate due to any adverse event |  | three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events related to tDCS procedure |  | three weeks | 
| Geriatric Depression Scale | a subjective scale for depressive symptoms | one week, two weeks, three weeks, five weeks (followup) | 
| Cornell Scale for Depression in Dementia | a objective scale for depressive symptoms | two weeks, three weeks, five weeks (followup) | 
| Neuropsychiatric Inventory | a objective scale for neuropsychiatric symptoms | three weeks, five weeks (followup) | 
| Zarit Burden Interview | a subjective scale for caregivers' burden | three weeks, five weeks (followup) | 
| Clinical Global Impression of Improvement | Clinician-rated impression of improvement | one, two, three and five weeks (followup) | 
| Starkstein Apathy Scale | a subjective scale for apathy | two, three and five weeks (followup) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuromodulation, Alzheimer's disease, Depressive symptoms, Neuropsychiatric symptoms, Behavioral and Psychological Symptoms of Dementia, Transcranial Direct Current Stimulation