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Enrolling by invitation NCT06817902

TMS Pilot in Early AD II

No phase Interventional Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intermittent theta burst stimulation active coil, Sham coil.
Who it may be relevant to
Registry conditions: Alzheimer Disease. Basic parameters: 40 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Preliminary Sham-Controlled Theta Burst Stimulation (TBS) Study in Early-Stage Alzheimer's Disease (AD)

Overview

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.

Interventions

  • Device Intermittent theta burst stimulation active coil
    MagVenture TMS Therapy active coil with theta burst stimulation. Resting motor threshold: 80%; Number of pulses per session: 1200 pulses; Inter-train interval: 8 seconds; Pulse frequency in burst: 50 Hertz
  • Device Sham coil
    MagVenture TMS Therapy sham coil

Primary outcome measures

  • Effect of TBS on cognition between and within subjects using Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS) [Time frame: baseline, 7 weeks]

Eligibility criteria

Inclusion criteria

  • Established diagnosis of Mild cognitive impairment (MCI)/mild AD
  • Evidence for central nervous system (CNS) amyloidosis (e.g., Amyloid Positron Emission Tomography (PET) or Cerebrospinal fluid (CSF) biomarkers consistent with AD)
  • Prior brain imaging performed
  • Mini Mental Status Examination (MMSE) >24
  • Clinical Dementia Rating (CDR) 0.5-1
  • Stable dose of cholinesterase inhibitors and memantine for at least one month
  • Subjects are between 40-90 years of age

Exclusion criteria

  • Non-AD dementia including, but not limited to, Lewy body dementia, frontotemporal dementia, vascular dementia, Jakob-Creutzfeldt disease, etc.
  • Inability to tolerate resting state-function magnetic resonance imaging (rs-fMRI)
  • Contraindication of rs-fMRI due to implants or metal
  • Seizure disorder

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • HealthPartners Neuroscience Center — Saint Paul

Identifiers

NCT: NCT06817902 · A21-251-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗