NCT06066710

Brief Summary

The purpose of this study is to find out how the language of people with Primary Progressive Aphasia is affected by Propranolol. Propranolol is not FDA approved for the treatment of Primary Progressive Aphasia. Propranolol is FDA approved for the treatment of heart conditions such as blood pressure. This research is being done because there are currently no drug treatment options for language impairments and anxiety often experienced by people with Primary Progressive Aphasia.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
19mo left

Started Jan 2025

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Jan 2025Dec 2027

First Submitted

Initial submission to the registry

September 8, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 13, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

1.9 years

First QC Date

September 8, 2023

Last Update Submit

March 24, 2025

Conditions

Aphasia, Primary Progressive

Outcome Measures

Primary Outcomes (1)

  • Change in Neuropsychological Assessment Battery Naming Test

    Day 1, 4 Weeks, 8 Weeks, 10 Weeks, 14 Weeks,18 Weeks

Secondary Outcomes (2)

  • Change in State-Trait Anxiety Inventory for Adults

    Day 1, 4 Weeks, 8 Weeks, 10 Weeks,14 Weeks,18 Weeks

  • Change in Semantic Word Fluency Tasks

    Day 1, 8 Weeks,18 Weeks

Study Arms (2)

Propanolol and MRI

EXPERIMENTAL

Participants will receive propranolol via oral capsule. The drug dosage will be titrated slowly to ensure the drug is tolerated well.

Drug: PropranololDevice: Magnetic Resonance Imaging (MRI)

Placebo and MRI

PLACEBO COMPARATOR

Participants will receive placebo via oral capsule.

Device: Magnetic Resonance Imaging (MRI)Drug: Placebo

Interventions

PropranololDRUG

Propranolol will be given on a titration schedule in which participants will begin with small doses of the drug and increase to a larger dosage over the course of three weeks. Propranolol will be taken for a total of 9 weeks.

Propanolol and MRI
Magnetic Resonance Imaging (MRI)DEVICE

Magnetic Resonance Imaging (MRI) will be performed at 3 Tesla and 7 Tesla, for both propranolol and placebo arms.

Placebo and MRIPropanolol and MRI
PlaceboDRUG

Placebo will be given on the same schedule as the propranolol regime.

Placebo and MRI

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Age: 50 and older
  • \. Primary Progressive Aphasia diagnosis
  • \. Native English speaker

You may not qualify if:

  • \. Unable to provide consent
  • \. Taking alpha 2 agonists (clonidine and guanfacine)
  • \. Other major psychological or neurological diagnosis
  • \. Major head trauma that contributed to their condition
  • \. Allergic reaction to adhesives
  • \. Uncorrected vision/hearing impairments
  • \. Diabetes
  • \. Reactive airway disease
  • \. Untreated hypothyroidism
  • \. Bradyarrhythmia
  • \. Unexplained syncope
  • \. Pregnancy (assessed verbally on the days of MR imaging)
  • \. Drugs that interact with propranolol, such as alpha 2 agonists
  • \. Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning. Subjects with any implanted device that cannot be verified as MRI compliant will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

RECRUITING

Related Publications (13)

  • Mesulam MM. Primary progressive aphasia. Ann Neurol. 2001 Apr;49(4):425-32.

    PMID: 11310619BACKGROUND

  • Mesulam M, Weintraub S. Primary progressive aphasia and kindred disorders. Handb Clin Neurol. 2008;89:573-87. doi: 10.1016/S0072-9752(07)01254-7. No abstract available.

    PMID: 18631780BACKGROUND

  • Gorno-Tempini ML, Hillis AE, Weintraub S, Kertesz A, Mendez M, Cappa SF, Ogar JM, Rohrer JD, Black S, Boeve BF, Manes F, Dronkers NF, Vandenberghe R, Rascovsky K, Patterson K, Miller BL, Knopman DS, Hodges JR, Mesulam MM, Grossman M. Classification of primary progressive aphasia and its variants. Neurology. 2011 Mar 15;76(11):1006-14. doi: 10.1212/WNL.0b013e31821103e6. Epub 2011 Feb 16.

    PMID: 21325651BACKGROUND

  • Johnson JK, Diehl J, Mendez MF, Neuhaus J, Shapira JS, Forman M, Chute DJ, Roberson ED, Pace-Savitsky C, Neumann M, Chow TW, Rosen HJ, Forstl H, Kurz A, Miller BL. Frontotemporal lobar degeneration: demographic characteristics of 353 patients. Arch Neurol. 2005 Jun;62(6):925-30. doi: 10.1001/archneur.62.6.925.

    PMID: 15956163BACKGROUND

  • Grossman M. Primary progressive aphasia: clinicopathological correlations. Nat Rev Neurol. 2010 Feb;6(2):88-97. doi: 10.1038/nrneurol.2009.216.

    PMID: 20139998BACKGROUND

  • Albert ML, Bachman DL, Morgan A, Helm-Estabrooks N. Pharmacotherapy for aphasia. Neurology. 1988 Jun;38(6):877-9. doi: 10.1212/wnl.38.6.877.

    PMID: 3368068BACKGROUND

  • Walker-Batson D, Curtis S, Natarajan R, Ford J, Dronkers N, Salmeron E, Lai J, Unwin DH. A double-blind, placebo-controlled study of the use of amphetamine in the treatment of aphasia. Stroke. 2001 Sep;32(9):2093-8. doi: 10.1161/hs0901.095720.

    PMID: 11546902BACKGROUND

  • Beversdorf DQ. Pharmacotherapy of aphasia. J Head Trauma Rehabil. 2007 Jan-Feb;22(1):65-6. doi: 10.1097/00001199-200701000-00008. No abstract available.

    PMID: 17235233BACKGROUND

  • Zamzow RM, Ferguson BJ, Stichter JP, Porges EC, Ragsdale AS, Lewis ML, Beversdorf DQ. Effects of propranolol on conversational reciprocity in autism spectrum disorder: a pilot, double-blind, single-dose psychopharmacological challenge study. Psychopharmacology (Berl). 2016 Apr;233(7):1171-8. doi: 10.1007/s00213-015-4199-0. Epub 2016 Jan 14.

    PMID: 26762378BACKGROUND

  • Beversdorf DQ, Sharma UK, Phillips NN, Notestine MA, Slivka AP, Friedman NM, Schneider SL, Nagaraja HN, Hillier A. Effect of propranolol on naming in chronic Broca's aphasia with anomia. Neurocase. 2007 Aug;13(4):256-9. doi: 10.1080/13554790701595471.

    PMID: 17886000BACKGROUND

  • Faigel HC. The effect of beta blockade on stress-induced cognitive dysfunction in adolescents. Clin Pediatr (Phila). 1991 Jul;30(7):441-5. doi: 10.1177/000992289103000706.

    PMID: 1879101BACKGROUND

  • Laverdure B, Boulenger JP. [Beta-blocking drugs and anxiety. A proven therapeutic value]. Encephale. 1991 Sep-Oct;17(5):481-92. French.

    PMID: 1686251BACKGROUND

  • Cahana-Amitay D, Albert ML, Pyun SB, Westwood A, Jenkins T, Wolford S, Finley M. Language as a Stressor in Aphasia. Aphasiology. 2011;25(2):593-614. doi: 10.1080/02687038.2010.541469. Epub 2011 Apr 19.

    PMID: 22701271BACKGROUND

MeSH Terms

Conditions

Aphasia, Primary Progressive

Interventions

PropranololMagnetic Resonance Imaging

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAphasiaSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • David Beversdorf, MD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Beversdorf, MD

CONTACT

573-882-6081beversdorfd@health.missouri.edu

Jessica Call

CONTACT

573-882-0515jccfx@health.missouri.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Radiology & Thompson Center for Autism & Neurodevelopmental Disorders, University of Missouri-Columbia

Study Record Dates

First Submitted

September 8, 2023

First Posted

October 4, 2023

Study Start

January 13, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

March 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)