Propranolol in Primary Progressive Aphasia

Aphasia, Primary Progressive Clinical Trial

Official title:

Trial of Propranolol in Older Adults With Primary Progressive Aphasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06066710
• Other study ID #: 2097152
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 2024
• Est. completion date: October 2026

Study information

• Verified date: June 2024
• Source: University of Missouri-Columbia
• Contact: David Beversdorf, MD
• Phone: 573-882-6081
• Email: beversdorfd[@]health.missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 1. Age: 50 and older

• 2. Primary Progressive Aphasia diagnosis

• 3. Native English speaker

Exclusion Criteria:

• 1. Unable to provide consent

• 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.

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Primary Progressive
• Frontotemporal Dementia
• Pick Disease of the Brain

Intervention

Drug:
• 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.

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

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

Locations

Country	Name	City	State
United States	University of Missouri-Columbia	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Neuropsychological Assessment Battery Naming Test		Day 1, 4 Weeks, 8 Weeks, 10 Weeks, 14 Weeks,18 Weeks
Secondary	Change in State-Trait Anxiety Inventory for Adults	The State-Trait Anxiety scores range from 20-40. A higher score indicates more anxiety.	Day 1, 4 Weeks, 8 Weeks, 10 Weeks,14 Weeks,18 Weeks
Secondary	Change in Semantic Word Fluency Tasks	The Semantic Word Fluency task measures the subject's ability to name as many items in a minute in a given category. The total number of correct and non-repeated responses are totaled for each category. There is no minimum or maximum score. Higher scores indicate better word fluency.	Day 1, 8 Weeks,18 Weeks