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| Name | Class |
|---|---|
| Texas Alzheimer's Research and Care Consortium | OTHER |
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The purpose of this study is to assess acceptability, and safety of providing tDCS to ADRD patients with behavioral symptoms and to assess the efficacy of tDCS for ADRD-related symptoms, mainly behavioral symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active tDCS | Experimental | All participants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with AD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active tDCS | Device | All participants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with AD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire | The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment. | week 2 |
| Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire | The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment. | week 4 |
| Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire | The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment. | week 6 |
| Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire | The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment. | week 12 |
| Safety as Assessed by the Side Effects Questionnaire | side effects include itching, burning, headache, fatigue, and dizziness. | week 2 |
| Safety as Assessed by the Side Effects Questionnaire | side effects include itching, burning, headache, fatigue, and dizziness. | week 4 |
| Safety as Assessed by the Side Effects Questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| 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, week 2, week 4, week 6, week 12 |
| Apathy as Assessed by the Brief Dimensional Apathy Scale (b-DAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kendra M Anderson, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Antonio L Teixeira, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States | ||
| The University of Texas Health Science Center at San Antonio |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active tDCS | All participants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with AD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down. active tDCS: All participants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with AD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 27, 2024 |
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side effects include itching, burning, headache, fatigue, and dizziness.
| week 6 |
This scale consists of 9 questions each one scored from 0(almost always) to 3(hardly ever), higher scores indicate more apathy |
| Baseline, Week 6 and Week 12. |
| Depressive Symptoms as Assessed by the Cornell Scale for Depression in Dementia (CSDD) | This questionnaire has 19 questions and each is scored from 0(absent) to 2(severe). A total score greater than 10 indicates probable major depressive episode and a score of greater than 18 indicates definite major depressive episode | Baseline, Week 6 and Week 12. |
| 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, Week 6 and Week 12. |
| San Antonio |
| Texas |
| 78229 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active tDCS | All participants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with AD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down. active tDCS: All participants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with AD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
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| Sex: Female, Male |
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| Ethnicity (NIH/OMB) |
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| Race (NIH/OMB) |
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| Region of Enrollment | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire | The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment. | Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | week 2 |
|
| |||||||||||||||||||
| Primary | Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire | The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment. | Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | week 4 |
|
| |||||||||||||||||||
| Primary | Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire | The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment. | Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | week 6 |
|
| |||||||||||||||||||
| Primary | Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire | The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment. | Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | week 12 |
|
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| Primary | Safety as Assessed by the Side Effects Questionnaire | side effects include itching, burning, headache, fatigue, and dizziness. | Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | week 2 |
|
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| Primary | Safety as Assessed by the Side Effects Questionnaire | side effects include itching, burning, headache, fatigue, and dizziness. | Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | week 4 |
|
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| Primary | Safety as Assessed by the Side Effects Questionnaire | side effects include itching, burning, headache, fatigue, and dizziness. | Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | week 6 |
|
| |||||||||||||||||||
| Secondary | 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. | Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | Baseline, week 2, week 4, week 6, week 12 |
|
| |||||||||||||||||||
| Secondary | 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), higher scores indicate more apathy | Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | Baseline, Week 6 and Week 12. |
|
| |||||||||||||||||||
| Secondary | Depressive Symptoms as Assessed by the Cornell Scale for Depression in Dementia (CSDD) | This questionnaire has 19 questions and each is scored from 0(absent) to 2(severe). A total score greater than 10 indicates probable major depressive episode and a score of greater than 18 indicates definite major depressive episode | Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | Baseline, Week 6 and Week 12. |
| ||||||||||||||||||||
| Secondary | 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. | Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | Baseline, Week 6 and Week 12. |
|
|
Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active tDCS | All participants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with AD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down. active tDCS: All participants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with AD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kendra M Anderson, PhD | The University of Texas Health Science Center at Houston | 713-486-0513 | Kendra.M.Anderson@uth.tmc.edu |
| Sep 22, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D053609 | Lethargy |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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