What side effects are associated with this type of intervention?

The most common treatments for Alzheimer's Disease include cholinesterase inhibitors such as donepezil, rivastigmine, and galantamine. These medications can cause side effects like nausea, vomiting, diarrhea, muscle cramps, and fatigue. Transcranial Magnetic Stimulation (TMS), which is being studied in combination with Constraint Induced Language Therapy (CILT), generally has mild side effects including headache, scalp discomfort, and, rarely, seizures. There are no serious adverse events reported for TMS in the context provided.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Alzheimer's Disease, primarily focusing on improving cognitive function and managing symptoms. These include cholinesterase inhibitors like donepezil, rivastigmine, and galantamine, which work by increasing levels of acetylcholine in the brain, and memantine, an NMDA receptor antagonist that helps regulate glutamate activity. While these drugs help manage symptoms, they do not cure the disease. There is emerging interest in non-pharmacological treatments such as Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells, and Constraint Induced Language Therapy (CILT), which focuses on intensive language practice to enhance verbal communication. However, these approaches are still under investigation and have not yet received FDA approval specifically for Alzheimer's Disease.

What other types of research exist?

Promising novel alternatives to TMS combined with CILT for Alzheimer's Disease patients include remote electrical neuromodulation, noninvasive vagus nerve stimulation (nVNS), and other intensive language training methods such as goal-directed/functional training and context-focused therapy. These approaches have shown efficacy in improving cognitive functions and communication skills in various neurological conditions and may offer benefits for Alzheimer's patients.

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Transcranial Magnetic Stimulation

TMS + CILT for Alzheimer's Disease

Phase 1

Waitlist Available

Led By H. Branch Coslett, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

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

Must have

A diagnosis of mild-moderate AD as defined by the National Institute of Aging - Alzheimer's Disease and Related Disorders Association criteria

Must be a native English speaker

Must not have

History of any other significant neurologic disease (e.g., ALS)

Any contraindications to TMS, including uncontrolled seizures, previous brain surgery, and history of tinnitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-months post-treatment

Summary

This trial tests if using magnetic brain stimulation along with a special speech therapy can help Alzheimer patients improve their speaking abilities. Magnetic brain stimulation stimulates brain activity, and the speech therapy encourages patients to use spoken language. Magnetic brain stimulation has shown promise in improving language performance in patients with Alzheimer's disease and poststroke aphasia.

Who is the study for?

This trial is for right-handed, native English speakers with mild to moderate Alzheimer's Disease (AD), having MMSE scores between 23 and 15. Participants must understand the study and consent. Excluded are those with a history of stroke, seizure, other major neurological diseases, significant depression or medical conditions that may interfere with the study.

What is being tested?

The trial tests if Transcranial Magnetic Stimulation (TMS) combined with Constraint Induced Language Therapy (CILT) can improve verbal communication in AD patients more effectively than sham TMS plus CILT. It also uses advanced neuroimaging to explore how this treatment works.

What are the potential side effects?

Potential side effects from TMS may include discomfort at the stimulation site, headache, lightheadedness, or seizures; however these are generally rare. The specifics of any additional side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with mild to moderate Alzheimer's disease.

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I am a native English speaker.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a history of significant neurological diseases like ALS.

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I don't have uncontrolled seizures, previous brain surgery, or tinnitus.

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I have had a stroke in the past.

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I have had seizures in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-months post-treatment 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 WAB-AQ

Secondary study objectives

Change in PNT

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active TMSActive Control2 Interventions

There will be 10 TMS sessions over 2 consecutive weeks in which 30 two-second stimulation trains of 10 Hz TMS will be delivered every 30 seconds to the left inferior pars triangularis and to the left posterior superior left temporal gyrus. Each TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).

Group II: Sham TMSPlacebo Group2 Interventions

There will be 10 TMS sessions over 2 consecutive weeks in which 30 two-second stimulation trains of 10 Hz sham TMS will be delivered every 30 seconds to the left inferior pars triangularis and to the left posterior superior left temporal gyrus. Sham TMS will be administered with a sham TMS coil that looks and sounds like the active coil but does not generate a magnetic field. Each TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).

0 / 6Eligibility 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 include cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and memantine. Cholinesterase inhibitors work by increasing levels of acetylcholine, a neurotransmitter important for memory and learning, thereby providing modest symptomatic relief. Memantine regulates glutamate activity to prevent excitotoxicity, which can damage neurons. These treatments are crucial as they help manage symptoms and improve quality of life, although they do not alter disease progression. Transcranial Magnetic Stimulation (TMS) combined with Constraint Induced Language Therapy (CILT) represents a novel approach, where TMS may enhance neural plasticity and cognitive functions, while CILT focuses on improving verbal communication through intensive practice. This combination could potentially offer more targeted and effective symptom management for Alzheimer's patients.