Clinical trial NCT04855643: Home-based tDCS for Apathy in Alzheimer's Disease
Official title: Home-based Transcranial Direct Current Stimulation (tDCS) for Apathy in Alzheimer's Disease and Related Dementias (ADRD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alzheimer Disease and Related Dementias
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Texas Alzheimer's Research and Care Consortium
First posted: 2021-04-22
Enrollment: 3
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Included and Who Successfully Completed the Protocol
timeFrame: through study completion (about 12 weeks)
measure: How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire
timeFrame: Baseline
measure: How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire
timeFrame: 2 weeks of treatment
measure: How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire
timeFrame: 4 weeks of treatment
measure: How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire
timeFrame: 6 weeks of treatment
measure: How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire
timeFrame: 6 weeks post-treatment (12 weeks from baseline)
measure: Safety of Home-based tDCS Treatment as Assessed by Side Effects
timeFrame: From baseline to week 12
Secondary outcomes:
measure: Apathy as Assessed by the Brief Dimensional Apathy Scale (b-DAS)
timeFrame: Baseline, treatment week 2 (2 weeks from baseline), treatment week 4 (4 weeks from baseline), treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment (12 weeks from baseline)
measure: Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Severity Score)
timeFrame: Baseline, treatment week 2 (2 weeks from baseline), treatment week 4 (4 weeks from baseline), treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment (12 weeks from baseline)
measure: Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Caregiver Distress Score)
timeFrame: Baseline, treatment week 2 (2 weeks from baseline), treatment week 4 (4 weeks from baseline), treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment (12 weeks from baseline)
measure: Depressive Symptoms as Assessed by the Cornell Scale for Depression in Dementia
timeFrame: Baseline, treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment (12 weeks from baseline)
measure: Cognition as Evaluated by the Mini-Mental State Examination (MMSE)
timeFrame: Baseline, treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment(12 weeks from baseline)
measure: Apathy as Measured by the Apathy Evaluation Scale (AES)
timeFrame: Baseline, treatment week 2 (2 weeks from baseline), treatment week 4 (4 weeks from baseline), treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment (12 weeks from baseline)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Antonio L Teixeira Jr, MD.PhD,MSc
role: PRINCIPAL_INVESTIGATOR
References: