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Home-based tDCS for Apathy in Alzheimer's Disease

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Terminated

Conditions

Alzheimer Disease and Related Dementias

Treatments

Device: home-based active tDCS
Device: home-based sham tDCS

Study type

Interventional

Funder types

Other

Identifiers

NCT04855643
HSC-MS-21-0089

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

3 participants in 2 patient groups

Treatment
Experimental group
Treatment:
Device: home-based active tDCS
Control Group
Sham Comparator group
Treatment:
Device: home-based sham tDCS

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Antonio L Teixeira Jr, MD,PhD,MSc; Lijin Jose, MD

Data sourced from clinicaltrials.gov

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