Effects of electrical stimulation on verbal learning in Alzheimer's disease

Transcranial Direct Current Stimulation in Typical and Atypical Alzheimer's Disease

This study is testing if using a special type of electrical stimulation can help people with Alzheimer's disease improve their verbal learning and memory skills.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 45 Years to 85 Years
• Sex: All
• Sponsor: Johns Hopkins University (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT04122001 on ClinicalTrials.gov

What this trial studies

This investigation evaluates the cognitive and neural effects of transcranial Direct Current Stimulation (tDCS) combined with a word-list learning intervention in patients with typical and atypical Alzheimer's disease. Utilizing a double-blind, sham-controlled, within-subject, cross-over design, participants will undergo two learning periods with either active tDCS or sham stimulation. Each period consists of 10 learning sessions over two weeks, followed by a wash-out period. The study aims to assess improvements in language associative learning and cognitive function through this innovative approach.

Who should consider this trial

Good fit: Ideal candidates are right-handed individuals aged 45-85 with logopenic variant Primary Progressive Aphasia and Alzheimer's disease biomarkers.

Not a fit: Patients with other forms of dementia or those not meeting the specific diagnostic criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance verbal learning and cognitive function in patients with Alzheimer's disease.

How similar studies have performed: Previous studies have shown positive effects of tDCS on cognitive function in neurodegenerative disorders, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

For the aphasic/atypical AD participants:

* Must be between 45-85 years of age.
* Must be right-handed.
* Must be proficient in English.
* Must have a minimum of high-school education.
* Must be diagnosed as logopenic variant Primary Progressive Aphasia (PPA) with Alzheimer's Disease (AD) biomarkers. Other possible diagnosis for the 'aphasic AD' variant would be Mild Cognitive Impairment (MCI) or 'possible AD' according to 2011 guidelines with AD biomarkers (CSF or positron emission tomography (PET) amyloid-beta or fluorodeoxyglucose (FDG)-positron emission tomography (PET) with unihemispheric atrophy).
* Participants will be diagnosed from PPA and early dementias clinics at Johns Hopkins University or other specialized centers in US using current consensus criteria. Diagnosis will be based on neuropsychological testing, language testing (most commonly the Western Aphasia Battery), MRI and clinical assessment. The investigators will also use two new variant classification tests the investigators have developed at the lab which discriminate PPA variants with great accuracy (above 80%): a spelling test and a speech production test (i.e.,Cookie Theft picture description task).

For the amnesic/typical AD participants:

* Must be between 45-85 years of age.
* Must be right-handed.
* Must be proficient in English.
* Must have a minimum of high-school education.
* Must be diagnosed with 'probable AD' in specialized diagnostic centers with neuropsychological (e.g., RAVLT) and AD biomarkers according to 2011 guidelines.
* The investigators will also perform extensive testing in the investigators' test battery including the Mnemonic Similarity Test (MST) that discriminates and measures the most salient hippocampal deficit-pattern separation (PS).

Exclusion Criteria:

* People with previous neurological disease including vascular dementia (e.g., stroke, developmental dyslexia, dysgraphia or attentional deficit).
* People with hearing loss (\> 25 decibel, using audiometric hearing screen).
* People with uncorrected visual acuity loss.
* People with advanced dementia or severe language impairments (MMSE \< 15, or Montreal Cognitive Assessment \<10, or language Frontotemporal Dementia-specific Clinical Dementia Rating (FTD-CDR) = 3).
* Left handed individuals.
* People with pre-existing psychiatric disorders such as behavioral disturbances, severe depression, or schizophrenia that do not allow these people to comply or follow the study schedule and requirements such as repeated evaluation and therapy.

Exclusion Criteria for MRI Participation:

* People with severe claustrophobia.
* People with cardiac pacemakers or ferromagnetic implants.
* Pregnant women.

Where this trial is running

Baltimore, Maryland

• Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Kyrana Tsapkini, PhD — Johns Hopkins University
• Study coordinator: Margaret Li

Conditions Alzheimer Disease, Early Onset; Atypical Alzheimer's Disease; Logopenic Progressive Aphasia; transcranial direct current stimulation; Alzheimer's Disease; verbal learning treatment; word list learning; logopenic Progressive Aphasia