Home-based tDCS for Apathy in Alzheimer's Disease

Study Overview
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Brief Summary
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The purpose of this study is to assess feasibility, acceptability, and safety of providing tDCS to Alzheimer's disease and related dementias (ADRD) patients with apathy and to assess the efficacy of tDCS for ADRD-related symptoms, with a primary focus on apathy.

Official Title
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Home-based Transcranial Direct Current Stimulation (tDCS) for Apathy in Alzheimer's Disease and Related Dementias (ADRD)

Conditions
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Alzheimer Disease and Related Dementias

Intervention / Treatment
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* Device: home-based active tDCS
* Device: home-based sham tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of possible or probable ADRD according to the National Institute of Aging - Alzheimer's Association diagnostic criteria Mild or moderate dementia, as defined by a MMSE score between 14 and 26 Clinically meaningful apathy for at least four weeks, clinically diagnosed according to 2018 Apathy Diagnostic Criteria or defined as Neuropsychiatric Inventory (NPI-Q) apathy score equal or above 4 (i.e., severity of 'moderate' or greater and caregiver distress 'mild' or greater). Stable doses of cholinesterase inhibitors, memantine and other psychotropic medications for at least three months. Exclusion Criteria: Unstable medical conditions History of epilepsy Metallic objects in the brain Diagnosis of major depression and/or a score higher than 18 on the Cornell Scale for Depression in Dementia

Ages Eligible for Study
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Minimum Age: 60 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 |
| --- | --- |
| Experimental: Treatment<br> | Device: home-based active tDCS<br>* Anode and cathode electrodes will be placed over the left and right dorsolateral prefrontal cortexes, respectively, with the use of the Omni-Lateral-Electrode system. Caregivers will set up and administer tDCS for participants with ADRD at home. tDCS will be applied for 30 min at an intensity of 2mA, with 30 s ramping up and down. All sessions will be remotely supervised by trained research staff.<br>|
| Sham Comparator: Control Group<br> | Device: home-based sham tDCS<br>* For sham stimulation, electric current will be applied only in the first 30s tDCS. All sessions will be remotely supervised by trained research staff.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants included and who successfully completed the protocol. | The feasibility will be assessed based on the recruitment rate (per month), randomization success, blind success, retention, and attrition rates. | through study completion, an average of 3 years | 
| How satisfied the patient was with the treatment as measured by the tDCS experience questionnaire. | Acceptability will be measured using a Likert scale composed by 10 questions, each one ranging from 0 (strongly disagree) to 10 (strongly agree). | Baseline | 
| How satisfied the patient was with the treatment as measured by the tDCS experience questionnaire. | Acceptability will be measured using a Likert scale composed by 10 questions, each one ranging from 0 (strongly disagree) to 10 (strongly agree). | 2 weeks of treatment | 
| How satisfied the patient was with the treatment as measured by the tDCS experience questionnaire. | Acceptability will be measured using a Likert scale composed by 10 questions, each one ranging from 0 (strongly disagree) to 10 (strongly agree). | 4 weeks of treatment | 
| How satisfied the patient was with the treatment as measured by the tDCS experience questionnaire. | Acceptability will be measured using a Likert scale composed by 10 questions, each one ranging from 0 (strongly disagree) to 10 (strongly agree). | 6 weeks of treatment | 
| How satisfied the patient was with the treatment as measured by the tDCS experience questionnaire. | Acceptability will be measured using a Likert scale composed by 10 questions, each one ranging from 0 (strongly disagree) to 10 (strongly agree). | 6 weeks post-treatment | 
| How safe home-based tDCS treatment is as measured by reporting side effects. | Safety will be assessed with a questionnaire about side effects that include itching, burning, headache, fatigue, and dizziness. | Baseline | 
| How safe home-based tDCS treatment is as measured by reporting side effects. | Safety will be assessed with a questionnaire about side effects that include itching, burning, headache, fatigue, and dizziness. | 2 weeks of treatment | 
| How safe home-based tDCS treatment is as measured by reporting side effects. | Safety will be assessed with a questionnaire about side effects that include itching, burning, headache, fatigue, and dizziness. | 4 weeks of treatment | 
| How safe home-based tDCS treatment is as measured by reporting side effects. | Safety will be assessed with a questionnaire about side effects that include itching, burning, headache, fatigue, and dizziness. | 6 weeks of treatment | 
| How safe home-based tDCS treatment is as measured by reporting side effects. | Safety will be assessed with a questionnaire about side effects that include itching, burning, headache, fatigue, and dizziness. | 6 weeks post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in apathy as assessed by the Brief Dimensional Apathy Scale (b-DAS) | This scale consists of 9 questions each one scored from 0(almost always) to 3(hardly ever) | Baseline, treatment week 2, treatment week 4, treatment week 6, and 6 weeks post-treatment. | 
| Change in dementia-related behavioral symptoms as assessed by the Neuropsychiatric Inventory (NPI-Q) scale | NPI-Q evaluates 12 discrete neuropsychiatric symptoms considering their severity and the related caregiver distress. | Baseline, treatment week 2, treatment week 4, treatment week 6, and 6 weeks post-treatment. | 
| Change in depressive symptoms as assessed by the Cornell Scale for Depression in Dementia | This scale consists of 19 questions and each question is scored on a two-point scale: 0 = absent; 1 = mild or intermittent; 2 = severe; n / a = unable to evaluate | Baseline, treatment week 6, and 6 weeks post-treatment. | 
| Change in cognition as evaluated by the Mini-Mental State Examination (MMSE) | Mini-Mental State Examination (MMSE) includes memory, language, praxis and orientation tasks, yielding a global cognition score ranging 0 to 30, with higher scores indicating better performance. | Baseline, treatment week 6, and 6 weeks post-treatment. | 
| Change in apathy as measured by the Apathy Evaluation Scale (AES) | 18 items phrased as questions that are to be answered by the caregiver on a four-point Likert scale, with higher scores indicating greater severity of apathy. | Baseline, treatment week 2, treatment week 4, treatment week 6, and 6 weeks post-treatment. |