Propranolol in Primary Progressive Aphasia

University of Missouri (MU)

Status and phase: Enrolling; Early Phase 1

Conditions: Aphasia, Primary Progressive

Treatments: Drug: Propranolol; Drug: Placebo; Device: Magnetic Resonance Imaging (MRI)

Study type: Interventional

Funder types: Other

Identifiers

NCT06066710

2097152

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Propanolol and MRI

Experimental group

Description:

Participants will receive propranolol via oral capsule. The drug dosage will be titrated slowly to ensure the drug is tolerated well.

Treatment:

Device: Magnetic Resonance Imaging (MRI)

Drug: Propranolol

Placebo and MRI

Placebo Comparator group

Description:

Participants will receive placebo via oral capsule.

Treatment:

Device: Magnetic Resonance Imaging (MRI)

Drug: Placebo