Aphasia, Primary Progressive
Conditions
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.
Interventions
DRUGPropranolol
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.
DEVICEMagnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging (MRI) will be performed at 3 Tesla and 7 Tesla, for both propranolol and placebo arms.
DRUGPlacebo
Placebo will be given on the same schedule as the propranolol regime.
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Neuropsychological Assessment Battery Naming Test | Day 1, 4 Weeks, 8 Weeks, 10 Weeks, 14 Weeks,18 Weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTDavid Beversdorf, MD
CONTACTKim Ray
PRINCIPAL_INVESTIGATORDavid Beversdorf, MD
University of Missouri-Columbia
Outcome results
None listed