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NCT04482179

Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for Alzheimer Disease

Completed Phase 1 Results posted Last updated 15 September 2025
What this trial tests

Phase 1 trial testing Active TMS in Alzheimer Disease in 23 participants. Completed in 31 August 2024.

Timeline
19 February 2020
Primary endpoint
31 August 2024
31 August 2024

Quick facts

Lead sponsorUniversity of Pennsylvania
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment23
Start date19 February 2020
Primary completion31 August 2024
Estimated completion31 August 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Pennsylvania

Who can join

Adults 60 to 85, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in WAB-AQ Score Primary · 12 weeks post-treatment

The primary outcome measure will be the change in score on the Western Aphasia Battery Aphasia Quotient (WAB-AQ), a score assessing overall aphasia recovery. Scores can range from 0-100, with higher scores representing better outcomes. 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild. A score of 93 or higher is considered recovered.

GroupValue95% CI
Active TMS-1.7± 4.3
Sham TMS-.1± 7.3
Change in Percentage of Items Correct on the PNT Secondary · 12 weeks post-treatment

The secondary outcome measure will be change in naming accuracy on the Philadelphia Naming Test (PNT). PNT naming accuracy is measured as a percentage from 0% to 100% with higher percentages meaning better naming ability. The task involves naming 175 pictures of common objects.

GroupValue95% CI
Active TMS-3.2± 8.2
Sham TMS-5.0± 6.1

Adverse events — posted to ClinicalTrials.gov

Time frame: From baseline, adverse event data were collected over a period of time consisting of 12 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active TMS
Serious: 1/7 (14%)
Deaths: 1/7
Sham TMS
Serious: 0/4 (0%)
Deaths: 0/4

Serious adverse events (1 terms)

ReactionSystemActive TMSSham TMS
Cardiac ArrestCardiac disorders
Other adverse events (6 terms — click to expand)

ReactionSystemActive TMSSham TMS
HeadacheGeneral disorders
Head PainGeneral disorders
DizzinessGeneral disorders
Stomach AcheGastrointestinal disorders
Heart PalpitationsCardiac disorders
FallGeneral disorders

Most-reported serious reactions: Cardiac Arrest.

Data from ClinicalTrials.gov NCT04482179 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Combining human and machine intelligence for clinical trial eligibility querying.
    Fang Y, Idnay B, Sun Y, Liu H, et al · · 2022 · cited 21× · PMID 35426943 · DOI 10.1093/jamia/ocac051
  2. Advanced Temporally-Spatially Precise Technologies for On-Demand Neurological Disorder Intervention.
    Chen X, Gong Y, Chen W. · · 2023 · cited 4× · PMID 36929323 · DOI 10.1002/advs.202207436
  3. The Potential for Neuromodulation in the Treatment of Alzheimer's Disease: A Review of Clinical Trials.
    Jones T, Shalom M, Chalamgari A, Gold J, et al · · 2025 · PMID 40599507 · DOI 10.7759/cureus.85156

Verify or expand the search:

Other trials of Active TMS

Trials testing the same drug.

Other recruiting trials for Alzheimer Disease

Currently open trials in the same condition.

Other University of Pennsylvania trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04482179.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing