3 Participants Needed

TMS for Apathy in Alzheimer's Disease

ME
Overseen ByMark Eldaief, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This proposal will demonstrate that non-invasive brain stimulation is able to modulate cortico-striatal circuits in neurodegenerative patients with apathy, and that doing so results in circuit-specific increases in FC and DA availability. These circuit changes will be accompanied by changes in specific behavioral dimensions of apathy. This work will lead to larger studies which develop personalized, circuit-specific neuromodulation strategies for AD patients suffering from this intractable neuropsychiatric symptom.

Will I have to stop taking my current medications?

If you are dependent on certain medications that affect dopamine, like some antidepressants or neuroleptics, you may need to stop taking them before joining the trial. You can participate if you can safely stop these medications and they are fully out of your system.

Is transcranial magnetic stimulation (TMS) safe for humans?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is generally safe for humans, including those with Alzheimer's disease and other conditions like depression. Studies have found it to be well-tolerated, with no major safety concerns reported.12345

How is the treatment TMS for apathy in Alzheimer's disease different from other treatments?

Transcranial Magnetic Stimulation (TMS) is unique because it uses magnetic fields to stimulate nerve cells in the brain, which is different from traditional drug treatments. It is non-invasive and has shown promise in improving apathy in conditions like mild cognitive impairment and stroke, where other treatments have limited effectiveness.12678

What data supports the effectiveness of the treatment TMS for apathy in Alzheimer's Disease?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can improve apathy in people with mild cognitive impairment, which is often a precursor to Alzheimer's disease. Additionally, rTMS has been shown to improve apathy in patients with chronic stroke, suggesting it may have potential benefits for similar symptoms in Alzheimer's patients.12678

Who Is on the Research Team?

ME

Mark Eldaief, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for individuals aged 50-80 with Alzheimer's disease, including atypical variants. They must have mild cognitive impairment (MMSE ≥22) and significant apathy symptoms as reported by a caregiver who will accompany them to visits.

Inclusion Criteria

I have been diagnosed with Alzheimer's disease, including any unusual forms.
Clinical Dementia Rating of 0.5 or mild 1.0 (MMSE equal to or greater than 22)
My caregiver reports I show strong signs of apathy, confirmed by a high AES-I score.
See 2 more

Exclusion Criteria

Involvement in any PET studies within 12 months
I do not have a history of seizures or any implants that would interfere with TMS.
I rely on medication that affects my brain's dopamine levels.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive repetitive transcranial magnetic stimulation (rTMS) targeting apathy-relevant circuits in Alzheimer's Disease patients

6 weeks
Multiple sessions per week

Follow-up

Participants are monitored for changes in apathy-related task performance, dopamine availability, mood scores, and resting-state connectivity

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • TMS
Trial Overview The study tests Intermittent Theta Burst Stimulation (iTBS), a non-invasive brain stimulation technique, to see if it can improve behavior related to apathy in Alzheimer's patients by affecting specific brain circuits.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Ventral circuit (vmPFC) stimulationExperimental Treatment1 Intervention
Group II: Dorsal circuit (DLPFC) stimulationExperimental Treatment1 Intervention
Group III: Sham stimulationPlacebo Group1 Intervention

TMS is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Transcranial Magnetic Stimulation for:
🇪🇺
Approved in European Union as Transcranial Magnetic Stimulation for:
🇨🇦
Approved in Canada as Transcranial Magnetic Stimulation for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Published Research Related to This Trial

Repetitive transcranial magnetic stimulation (rTMS) has shown a positive impact on apathy in patients with Alzheimer's disease and some potential benefits in chronic stroke, suggesting it may be a feasible treatment option for these conditions.
The safety of rTMS was confirmed across various studies, but its efficacy varied significantly among different neurodegenerative conditions, with limited evidence of effectiveness in Parkinson's disease and mild traumatic brain injury.
Repetitive transcranial magnetic stimulation for apathy in patients with neurodegenerative conditions, cognitive impairment, stroke, and traumatic brain injury: a systematic review.Espiritu, AI., Hara, T., Tolledo, JK., et al.[2023]
Repetitive transcranial magnetic stimulation (rTMS) significantly improved apathy in older adults with Mild Cognitive Impairment (MCI) after 2 weeks of treatment, as measured by the Apathy Evaluation Scale-Clinical version (AES-C).
In addition to reducing apathy, rTMS also led to notable improvements in cognitive function and executive tasks, indicating its potential as a therapeutic intervention for MCI-related symptoms.
Repetitive transcranial magnetic stimulation for apathy in mild cognitive impairment: A double-blind, randomized, sham-controlled, cross-over pilot study.Padala, PR., Padala, KP., Lensing, SY., et al.[2022]
The NeuroAD procedure, which combines repetitive transcranial magnetic stimulation with cognitive training, showed long-term improvements in apathy among Alzheimer's disease patients, with significant benefits observed even 28 months after treatment initiation.
While cognitive scores improved initially, they deteriorated over time, indicating that the NeuroAD procedure may be particularly effective for patients who respond well to the initial treatment, highlighting the need for further research to identify predictors of success.
Multi-site rTMS with cognitive training improves apathy in the long term in Alzheimer's disease: A 4-year chart review.Suarez Moreno, A., Nguyen, JP., Calmelet, A., et al.[2022]

Citations

Repetitive transcranial magnetic stimulation for apathy in patients with neurodegenerative conditions, cognitive impairment, stroke, and traumatic brain injury: a systematic review. [2023]
Repetitive transcranial magnetic stimulation for apathy in mild cognitive impairment: A double-blind, randomized, sham-controlled, cross-over pilot study. [2022]
Multi-site rTMS with cognitive training improves apathy in the long term in Alzheimer's disease: A 4-year chart review. [2022]
The Efficacy of High-Frequency Repetitive Transcranial Magnetic Stimulation for Improving Apathy in Chronic Stroke Patients. [2018]
5.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Efficacy of Transcranial Direct Current Stimulation Combined with Cognitive Training in the Treatment of Apathy in Patients with Alzheimer's Disease: Study Protocol for a Randomized Trial. [2019]
Open-label, short-term, repetitive transcranial magnetic stimulation in patients with Alzheimer's disease with functional imaging correlates and literature review. [2014]
Repetitive transcranial magnetic stimulation combined with cognitive training is a safe and effective modality for the treatment of Alzheimer's disease: a randomized, double-blind study. [2021]
Safety of transcranial magnetic stimulation in unipolar depression: A systematic review and meta-analysis of randomized-controlled trials. [2022]
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