Clinical trial

Trial of Propranolol in Older Adults With Primary Progressive Aphasia

Name

2097152

Description

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.

Trial arms

Trial start

2024-05-01

Estimated PCD

2026-10-01

Trial end

2026-10-01

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

Propanolol and MRI

Magnetic Resonance Imaging (MRI)

Magnetic Resonance Imaging (MRI) will be performed at 3 Tesla and 7 Tesla, for both propranolol and placebo arms.

Arms:

Placebo and MRI, Propanolol and MRI

Placebo

Placebo will be given on the same schedule as the propranolol regime.

Arms:

Placebo and MRI

Size

Primary endpoint

Change in Neuropsychological Assessment Battery Naming Test

Day 1, 4 Weeks, 8 Weeks, 10 Weeks, 14 Weeks,18 Weeks

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

Updated at

2024-02-29

1 organization

2 products

2 indications

Organization

University of Missouri-Columbia

Product

Indication

Indication

Product