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Phase 1 Completed N=11 Randomized Quadruple-blind Treatment

Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for Alzheimer Disease

Alzheimer Disease
Source: ClinicalTrials.gov NCT04482179 ↗
Enrolled (actual)
11
Serious AEs
9.1%
Results posted
Sep 2025
Primary outcomePrimary: Change in WAB-AQ Score — -1.7; -.1 score on a scale — p=<.05

Summary

Impaired verbal communication is a cardinal symptom of Alzheimer Disease (AD) and the source of enormous distress and disability. Effective therapies for this deficit are lacking. In light of the emerging literature demonstrating that Transcranial Magnetic Stimulation (TMS) improves general cognition in subjects with Alzheimer Disease (AD), the investigators propose to study the effectiveness of TMS as a therapy for impaired verbal communication. The hypothesis to be tested is that TMS combined with Constraint Induced Language Therapy (CILT) improves verbal communication more than sham TMS and CILT. A second aim is to use state-of-the-art neuroimaging to understand the mechanisms underlying any beneficial effect of the treatment.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in WAB-AQ Score
-1.7; -.1 <.05 sig
SECONDARY
Change in Percentage of Items Correct on the PNT
-3.2; -5.0 <.05 sig

Eligibility Criteria

Inclusion Criteria

  • A diagnosis of mild-moderate AD as defined by the National Institute of Aging - Alzheimer's Disease and Related Disorders Association criteria
  • Mild-moderate cognitive impairment, indicated by Mini-Mental Status Exam (MMSE) scores between 23 and 15 inclusive
  • Must be right handed as defined by the Edinburgh Handedness Inventory
  • Must be a native English speaker
  • Must be able to understand the nature of the study, and give informed consent

Exclusion Criteria

  • History of stroke
  • History of seizure
  • History of any other significant neurologic disease (e.g., ALS)
  • Significant depression as defined by the Geriatric Depression Scale.
  • Any significant medical disorder that, in the view of the investigators, could threaten the subject's ability to complete the study (e.g., cancer, significant cardiac disease)
  • Any contraindications to TMS, including uncontrolled seizures, previous brain surgery, and history of tinnitus
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04482179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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