Propranolol in Primary Progressive Aphasia

Study Overview
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Brief Summary
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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.

Official Title
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Trial of Propranolol in Older Adults With Primary Progressive Aphasia

Conditions
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Aphasia, Primary Progressive

Intervention / Treatment
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* Drug: Propranolol
* Device: Magnetic Resonance Imaging (MRI)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propanolol and MRI<br>Participants will receive propranolol via oral capsule. The drug dosage will be titrated slowly to ensure the drug is tolerated well. | Drug: Propranolol<br>* 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.<br>Device: Magnetic Resonance Imaging (MRI)<br>* Magnetic Resonance Imaging (MRI) will be performed at 3 Tesla and 7 Tesla, for both propranolol and placebo arms.<br>|
| Placebo Comparator: Placebo and MRI<br>Participants will receive placebo via oral capsule. | Device: Magnetic Resonance Imaging (MRI)<br>* Magnetic Resonance Imaging (MRI) will be performed at 3 Tesla and 7 Tesla, for both propranolol and placebo arms.<br>Drug: Placebo<br>* Placebo will be given on the same schedule as the propranolol regime.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Neuropsychological Assessment Battery Naming Test |  | 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 | 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 | 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 |