Back to resultsPropranolol in Primary Progressive Aphasia
Primary Purpose
Aphasia, Primary Progressive
Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Propranolol
Magnetic Resonance Imaging (MRI)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia, Primary Progressive
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.
Sites / Locations
- University of Missouri-Columbia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Propanolol and MRI
Placebo and MRI
Arm Description
Participants will receive propranolol via oral capsule. The drug dosage will be titrated slowly to ensure the drug is tolerated well.
Participants will receive placebo via oral capsule.
Outcomes
Primary Outcome Measures
Change in Neuropsychological Assessment Battery Naming Test
Secondary Outcome Measures
Change in State-Trait Anxiety Inventory for Adults
The State-Trait Anxiety scores range from 20-40. A higher score indicates more anxiety.
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.
Full Information
NCT ID
NCT06066710
First Posted
September 8, 2023
Last Updated
September 27, 2023
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT06066710
Brief Title
Propranolol in Primary Progressive Aphasia
Official Title
Trial of Propranolol in Older Adults With Primary Progressive Aphasia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Primary Progressive
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Propanolol and MRI
Arm Type
Experimental
Arm Description
Participants will receive propranolol via oral capsule. The drug dosage will be titrated slowly to ensure the drug is tolerated well.
Arm Title
Placebo and MRI
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo via oral capsule.
Intervention Type
Drug
Intervention Name(s)
Propranolol
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Imaging (MRI)
Intervention Description
Magnetic Resonance Imaging (MRI) will be performed at 3 Tesla and 7 Tesla, for both propranolol and placebo arms.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be given on the same schedule as the propranolol regime.
Primary Outcome Measure Information:
Title
Change in Neuropsychological Assessment Battery Naming Test
Time Frame
Day 1, 4 Weeks, 8 Weeks, 10 Weeks, 14 Weeks,18 Weeks
Secondary Outcome Measure Information:
Title
Change in State-Trait Anxiety Inventory for Adults
Description
The State-Trait Anxiety scores range from 20-40. A higher score indicates more anxiety.
Time Frame
Day 1, 4 Weeks, 8 Weeks, 10 Weeks,14 Weeks,18 Weeks
Title
Change in Semantic Word Fluency Tasks
Description
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.
Time Frame
Day 1, 8 Weeks,18 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Beversdorf, MD
Phone
573-882-6081
Email
beversdorfd@health.missouri.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joanne Cassani, RN
Phone
573-882-3677
Email
cassanij@health.missouri.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Beversdorf, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri-Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Beversdorf, MD
Phone
573-882-6081
Email
beversdorfd@health.missouri.edu
First Name & Middle Initial & Last Name & Degree
Joanne Cassani, RN
Phone
573-882-3677
Email
cassanij@health.missouri.edu
12. IPD Sharing Statement
Citations:
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11310619
Citation
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Propranolol in Primary Progressive Aphasia
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