Home-based tDCS for Apathy in Alzheimer's Disease

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-20

Study Completion Date

2022-07-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05478681

Alzheimer Disease

COMPLETED NA

Effects of Transcranial Direct Current Stimulation on the Apathy of Alzheimer's Disease

NCT01481558

Apathy Alzheimer's Disease

COMPLETED PHASE2

Transcranial Direct Current Stimulation for Depression in Alzheimer's Disease Patient - Preliminary Research

NCT02351388

Alzheimer Disease Depression

TERMINATED NA

Influence of tDCS on Cortical Plasticity in Patients With Dementia of the Alzheimer Type

NCT01887899

Dementia of Type Alzheimer

WITHDRAWN NA

Transcranial Direct Current Stimulation (tDCS) as a Cognitive Enhancer for Patients With Alzheimers Disease

NCT02518412

Alzheimer Disease

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease and Related Dementias

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment

Group Type EXPERIMENTAL

home-based active tDCS

Intervention Type DEVICE

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.

Control Group

Group Type SHAM_COMPARATOR

home-based sham tDCS

Intervention Type DEVICE

For sham stimulation, electric current will be applied only in the first 30s tDCS. All sessions will be remotely supervised by trained research staff.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

home-based active tDCS

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.

Intervention Type DEVICE

home-based sham tDCS

For sham stimulation, electric current will be applied only in the first 30s tDCS. All sessions will be remotely supervised by trained research staff.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No