Propranolol in Primary Progressive Aphasia

Early Phase 1

Recruiting

• Conditions: Aphasia, Primary Progressive
• Interventions: Drug: Propranolol; Device: Magnetic Resonance Imaging (MRI); Drug: Placebo

• Registration Number: NCT06066710
• Lead Sponsor: University of Missouri-Columbia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-27
• Study First Posted: 2023-10-04
• Study Start: 2025-01-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Propanolol and MRI	Magnetic Resonance Imaging (MRI)	Participants will receive propranolol via oral capsule. The drug dosage will be titrated slowly to ensure the drug is tolerated well.
Placebo and MRI	Magnetic Resonance Imaging (MRI)	Participants will receive placebo via oral capsule.
Placebo and MRI	Placebo	Participants will receive placebo via oral capsule.
Propanolol and MRI	Propranolol	Participants will receive propranolol via oral capsule. The drug dosage will be titrated slowly to ensure the drug is tolerated well.

Primary Outcome Measures

Name	Time	Method
Change in Neuropsychological Assessment Battery Naming Test	Day 1, 4 Weeks, 8 Weeks, 10 Weeks, 14 Weeks,18 Weeks

Secondary Outcome Measures

Name	Time	Method
Change in State-Trait Anxiety Inventory for Adults	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.
Change in Semantic Word Fluency Tasks	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.

Trial Locations

Locations (1)

University of Missouri-Columbia; 🇺🇸 Columbia, Missouri, United States