Propranolol in Primary Progressive Aphasia

Sponsor

University of Missouri-Columbia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06066710

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aphasia, Primary Progressive	Drug: Propranolol Device: Magnetic Resonance Imaging (MRI) Drug: Placebo	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Trial of Propranolol in Older Adults With Primary Progressive Aphasia

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2026

Anticipated Study Completion Date :

Oct 1, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Propanolol and MRI

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

Drug: 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.

Device: Magnetic Resonance Imaging (MRI)

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

Placebo Comparator: Placebo and MRI

Participants will receive placebo via oral capsule.

Device: Magnetic Resonance Imaging (MRI)

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

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

Change in Neuropsychological Assessment Battery Naming Test [Day 1, 4 Weeks, 8 Weeks, 10 Weeks, 14 Weeks,18 Weeks]

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. Age: 50 and older
1. Primary Progressive Aphasia diagnosis
1. Native English speaker

Exclusion Criteria:

1. Unable to provide consent
1. Taking alpha 2 agonists (clonidine and guanfacine)
1. Other major psychological or neurological diagnosis
1. Major head trauma that contributed to their condition
1. Allergic reaction to adhesives
1. Uncorrected vision/hearing impairments
1. Diabetes
1. Reactive airway disease
1. Untreated hypothyroidism
1. Bradyarrhythmia
1. Unexplained syncope
1. Pregnancy (assessed verbally on the days of MR imaging)
1. Drugs that interact with propranolol, such as alpha 2 agonists
1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Missouri-Columbia	Columbia	Missouri	United States	65212

Sponsors and Collaborators

University of Missouri-Columbia

Investigators

Principal Investigator: David Beversdorf, MD, University of Missouri-Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

David Beversdorf, Professor, Department of Radiology & Thompson Center for Autism & Neurodevelopmental Disorders, University of Missouri-Columbia, University of Missouri-Columbia

ClinicalTrials.gov Identifier:

NCT06066710

Other Study ID Numbers: