Propranolol in Primary Progressive Aphasia

March 24, 2025 updated by: David Beversdorf, University of Missouri-Columbia

Trial of Propranolol in Older Adults with Primary Progressive Aphasia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propanolol and MRI
Participants will receive propranolol via oral capsule. The drug dosage will be titrated slowly to ensure the drug is tolerated well.
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.
Placebo Comparator: Placebo and MRI
Participants will receive placebo via oral capsule.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Neuropsychological Assessment Battery Naming Test
Time Frame: Day 1, 4 Weeks, 8 Weeks, 10 Weeks, 14 Weeks,18 Weeks
Day 1, 4 Weeks, 8 Weeks, 10 Weeks, 14 Weeks,18 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in State-Trait Anxiety Inventory for Adults
Time Frame: Day 1, 4 Weeks, 8 Weeks, 10 Weeks,14 Weeks,18 Weeks
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
Change in Semantic Word Fluency Tasks
Time Frame: Day 1, 8 Weeks,18 Weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Investigators

  • Principal Investigator: David Beversdorf, MD, University of Missouri-Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 8, 2023

First Submitted That Met QC Criteria

September 27, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2097152

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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