TerminatedNot Applicable

Home-based tDCS for Apathy in Alzheimer's Disease

Stopped: PI moved to a new institution

United States3 participantsStarted 2021-08-20

Plain-language 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.

Who can participate

Age range60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants Included and Who Successfully Completed the Protocol

Timeframe: through study completion (about 12 weeks)

How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire

Timeframe: Baseline

How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire

Timeframe: 2 weeks of treatment

How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire

Timeframe: 4 weeks of treatment

How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire

Timeframe: 6 weeks of treatment

How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire

Timeframe: 6 weeks post-treatment (12 weeks from baseline)

Safety of Home-based tDCS Treatment as Assessed by Side Effects

Timeframe: From baseline to week 12

Trial details

NCT IDNCT04855643

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-10

Results submitted2024-02-14

View on ClinicalTrials.gov More Alzheimer Disease and Related Dementias trials

Who can participate

Age range60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants Included and Who Successfully Completed the Protocol

Timeframe: through study completion (about 12 weeks)

How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire

Timeframe: Baseline

How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire

Timeframe: 2 weeks of treatment

How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire

Timeframe: 4 weeks of treatment

How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire

Timeframe: 6 weeks of treatment

How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire

Timeframe: 6 weeks post-treatment (12 weeks from baseline)

Safety of Home-based tDCS Treatment as Assessed by Side Effects

Timeframe: From baseline to week 12