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Recruiting NCT06066710

Propranolol in Primary Progressive Aphasia

Early Phase I Interventional Aphasia, Primary Progressive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Propranolol, Magnetic Resonance Imaging (MRI), Placebo.
Who it may be relevant to
Registry conditions: Aphasia, Primary Progressive. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Trial of Propranolol in Older Adults With Primary Progressive Aphasia

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Change in Neuropsychological Assessment Battery Naming Test [Time frame: Day 1, 4 Weeks, 8 Weeks, 10 Weeks, 14 Weeks,18 Weeks]
Secondary outcome measures (2)
  • Change in State-Trait Anxiety Inventory for Adults [Time frame: Day 1, 4 Weeks, 8 Weeks, 10 Weeks,14 Weeks,18 Weeks]
  • Change in Semantic Word Fluency Tasks [Time frame: Day 1, 8 Weeks,18 Weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Missouri-Columbia — Columbia

Publications

  • Mesulam MM. Primary progressive aphasia. Ann Neurol. 2001 Apr;49(4):425-32. PMID 11310619
  • 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 18631780
  • 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 21325651
  • 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 15956163
  • Grossman M. Primary progressive aphasia: clinicopathological correlations. Nat Rev Neurol. 2010 Feb;6(2):88-97. doi: 10.1038/nrneurol.2009.216. PMID 20139998
  • 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 3368068
  • 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 11546902
  • 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 17235233

Identifiers

NCT: NCT06066710 · 2097152

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗