Transcranial Magnetic Stimulation for Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

Overseen ByBhavani Kashyap, MBBS, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: HealthPartners Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?Alzheimer's disease (AD) is a progressive neurodegenerative condition affecting 6.2 million individuals in the United States, resulting in an annual cost of care of $305 billion. AD is functionally characterized by progressive degeneration of large-scale brain networks (LSBNs), including the default mode network (DMN) presumably from the deposition of amyloid plaques and neurofibrillary tangles. Available FDA-approved medications for AD such as donepezil and memantine offer limited benefit and modest impact on quality of life. Transcranial magnetic stimulation (TMS) with intermittent theta burst stimulation (iTBS) offers a non-invasive alternative to pharmacotherapy in persons with AD. We propose a case series study to compare sham with iTBS.

Eligibility Criteria

This trial is for people aged 40-90 with Mild Cognitive Impairment or mild Alzheimer's Disease, scoring over 24 on the MMSE and having a CDR of 0.5-1. Participants must show evidence of amyloidosis in the brain and have been on a stable dose of Alzheimer's medications for at least one month.

Inclusion Criteria

I am between 40 and 90 years old.

I have been diagnosed with mild cognitive impairment or mild Alzheimer's disease.

I have signs of amyloid in my brain confirmed by tests.

Exclusion Criteria

My condition is a type of dementia, but not Alzheimer's disease.

I have a seizure disorder.

Participant Groups

The study tests if transcranial magnetic stimulation (TMS) using intermittent theta burst stimulation (iTBS) can be an effective non-invasive treatment compared to a sham (placebo-like) procedure in individuals with early-stage Alzheimer's Disease.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intermittent theta burst stimulationExperimental Treatment1 Intervention

Subjects will receive treatment with intermittent theta burst stimulation (iTBS) with the active coil. There will be a total of 5 treatments over a 2-week period. All subjects will receive iTBS to the 8Av region. TBS treatment will also be provided for two additional sites within the large-scale brain networks (LSBNs) that is found to contain the greatest number of connectivity anomalies. Total participation will be 6-9 weeks.

Group II: Sham devicePlacebo Group1 Intervention

Subjects will receive treatment with sham coil. There will be a total of 5 treatments over a 2-week period. Coil will be placed over the same region as the experimental group. Total participation will be 6-9 weeks. An open-label extension will be offered to participants that received the sham (control) treatment without further data collection.