What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Alzheimer's Disease, primarily focusing on symptom management rather than disease modification. These include cholinesterase inhibitors like donepezil, rivastigmine, and galantamine, as well as the NMDA receptor antagonist memantine. While these drugs aim to improve cognitive function and slow disease progression, recent research has explored non-pharmacological approaches such as Transcranial Direct Current Stimulation (tDCS). tDCS is a non-invasive method that enhances synaptic activity and has shown promise in improving verbal learning and memory in Alzheimer's patients. However, tDCS itself is not yet FDA-approved for Alzheimer's treatment, and further studies are needed to establish its efficacy and safety.

What other types of research exist?

Promising novel alternatives to Transcranial Direct Current Stimulation (tDCS) for Alzheimer's Disease patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in improving cognitive functions and is non-invasive. 2) Noninvasive Vagus Nerve Stimulation (nVNS), which has demonstrated benefits in neurological conditions and may offer cognitive improvements. Both methods are non-invasive and have been approved for use in other neurological conditions, making them viable alternatives for consideration in 2024.

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Electrical Stimulation

Electrical Stimulation for Learning and Memory in Alzheimer's and Primary Progressive Aphasia

Q: What side effects are associated with this type of intervention?

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, with mild side effects such as tingling, itching, or redness at the site of stimulation. Other common treatments for Alzheimer's Disease include cholinesterase inhibitors like donepezil, rivastigmine, and galantamine. These medications can cause side effects such as nausea, vomiting, diarrhea, muscle cramps, and loss of appetite. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

Verified Trial

N/A

Recruiting

Led By Kyrana Tsapkini, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have you had any previous brain injuries (stroke, traumatic brain injury, tumors)?

Are you right-handed?

Timeline

Screening 2 days

Treatment 6 months

Follow Up 0 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment for Alzheimer's patients using a gentle electrical brain stimulation combined with memory exercises. It aims to help those who struggle with memory or language by improving brain cell connections. Transcutaneous electrical nerve stimulation (TENS) has shown positive effects on memory, verbal fluency, and affective behavior in Alzheimer's patients in previous studies.

Who is the study for?

This trial is for right-handed individuals aged 50-75 with a high-school education, proficient in English, and diagnosed with Alzheimer's Disease or Primary Progressive Aphasia. They must have cognitive impairment consistent with AD biomarkers but no history of brain injuries like stroke or tumors.

What is being tested?

The study tests if electrical brain stimulation (HD-tDCS) combined with a Word List Learning Intervention can improve verbal learning in typical and atypical Alzheimer's patients by comparing active treatment to sham (placebo). It also examines changes in brain connectivity and neurotransmitter levels.

What are the potential side effects?

While the document doesn't specify side effects, tDCS is generally considered safe but may cause mild discomfort, itching, tingling on the scalp during application, headache, fatigue or nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had a previous brain injury.

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I have been diagnosed with Alzheimer's Disease or Primary Progressive Aphasia.

Timeline

Screening ~ 2 days0 visits

Treatment ~ 6 months30 visits

Follow Up ~ 0 days1 visit

Screening ~ 2 days

Treatment ~ 6 months

Follow Up ~0 days

This trial's timeline: 2 days for screening, 6 months for treatment, and 0 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in auditory delayed recall accuracy of semantically related - trained word-lists

Change in auditory delayed recall accuracy of semantically related - untrained word-lists

Change in auditory delayed recall accuracy of semantically unrelated - trained word-lists

+5 more

Secondary study objectives

Change in Gamma-Aminobutyric Acid (GABA) concentration

Change in Mini Mental State Examination (MMSE)

Change in Mnemonic Similarity Task (MST) score

+22 more

Other study objectives

Correlation of primary and with sleep efficiency

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sham+word intervention then active HD-tDCS+word interventionExperimental Treatment3 Interventions

Participants will receive Sham + Word List Learning Intervention (WordLLI) and then active HD-tDCS + WordLLI after a three-month washout period.

Group II: Active HD-tDCS+word intervention then Sham+word interventionExperimental Treatment3 Interventions

Participants will receive active HD-tDCS + Word List Learning Intervention (WordLLI) and then receive Sham + WordLLI after a three-month washout period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Active HD-tDCS

2016

N/A

~90

Sham

2013

Completed Phase 3

~2090

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Alzheimer's Disease (AD) include cholinesterase inhibitors and neuromodulation techniques such as Transcranial Direct Current Stimulation (tDCS). Cholinesterase inhibitors, like donepezil, rivastigmine, and galantamine, work by increasing cholinergic transmission in the brain, which can provide modest symptomatic relief in cognition and global functioning. tDCS, a non-invasive neuromodulation technique, enhances synaptic activity and functional connectivity in the brain, particularly in areas involved in language and memory. This is significant for AD patients as it may help mitigate cognitive decline and improve verbal learning and memory functions, potentially enhancing their quality of life.

Neurostimulation in Alzheimer's disease: from basic research to clinical applications.2,2',4'-trihydroxychalcone from Glycyrrhiza glabra as a new specific BACE1 inhibitor efficiently ameliorates memory impairment in mice.