Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
30 participants
INTERVENTIONAL
2025-01-13
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Propanolol and MRI
Participants will receive propranolol via oral capsule. The drug dosage will be titrated slowly to ensure the drug is tolerated well.
Propranolol
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.
Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging (MRI) will be performed at 3 Tesla and 7 Tesla, for both propranolol and placebo arms.
Placebo and MRI
Participants will receive placebo via oral capsule.
Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging (MRI) will be performed at 3 Tesla and 7 Tesla, for both propranolol and placebo arms.
Placebo
Placebo will be given on the same schedule as the propranolol regime.
Interventions
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Propranolol
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.
Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging (MRI) will be performed at 3 Tesla and 7 Tesla, for both propranolol and placebo arms.
Placebo
Placebo will be given on the same schedule as the propranolol regime.
Eligibility Criteria
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Inclusion Criteria
* 2\. Primary Progressive Aphasia diagnosis
* 3\. Native English speaker
Exclusion Criteria
* 2\. Taking alpha 2 agonists (clonidine and guanfacine)
* 3\. Other major psychological or neurological diagnosis
* 4\. Major head trauma that contributed to their condition
* 5\. Allergic reaction to adhesives
* 6\. Uncorrected vision/hearing impairments
* 7\. Diabetes
* 8\. Reactive airway disease
* 9\. Untreated hypothyroidism
* 10\. Bradyarrhythmia
* 11\. Unexplained syncope
* 12\. Pregnancy (assessed verbally on the days of MR imaging)
* 13\. Drugs that interact with propranolol, such as alpha 2 agonists
* 14\. 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.
50 Years
ALL
No
Sponsors
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University of Missouri-Columbia
OTHER
Responsible Party
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David Beversdorf
Professor, Department of Radiology & Thompson Center for Autism & Neurodevelopmental Disorders, University of Missouri-Columbia
Principal Investigators
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David Beversdorf, MD
Role: PRINCIPAL_INVESTIGATOR
University of Missouri-Columbia
Locations
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University of Missouri-Columbia
Columbia, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Mesulam MM. Primary progressive aphasia. Ann Neurol. 2001 Apr;49(4):425-32.
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.
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.
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.
Grossman M. Primary progressive aphasia: clinicopathological correlations. Nat Rev Neurol. 2010 Feb;6(2):88-97. doi: 10.1038/nrneurol.2009.216.
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.
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.
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.
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.
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.
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.
Laverdure B, Boulenger JP. [Beta-blocking drugs and anxiety. A proven therapeutic value]. Encephale. 1991 Sep-Oct;17(5):481-92. French.
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.
Other Identifiers
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2097152
Identifier Type: -
Identifier Source: org_study_id
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