Rehabilitation and Prophylaxis of Anomia in Primary Progressive Aphasia
Primary Purpose
Aphasia, Primary Progressive, Anomia, Alzheimer Disease
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phonological
Orthographic
Semantic
Lexical
Untrained
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia, Primary Progressive
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Primary Progressive Aphasia (PPA; including Frontotemporal Dementia, Semantic Dementia, or a similar condition) or Diagnosis of Alzheimer's Disease
- At least 10 years of education
- Ability to follow spoken instructions
- Medically stable
- First language is English, or fluent in English since childhood
- Willing to participate over a period of two years
Exclusion Criteria:
- No history of additional neurological problems
- No history of substance abuse or psychiatric problems
Sites / Locations
- Georgetown University Medical Center
- Johns Hopkins University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Phonological, Orthographic, Untrained
Semantic, Lexical, Untrained
Arm Description
Outcomes
Primary Outcome Measures
Change in picture naming accuracy for words within each treatment condition during treatment
The change in picture naming accuracy for trained words will be compared with the change in picture naming accuracy for words that were tested at baseline but never trained during the treatment phase.
Secondary Outcome Measures
Change in picture naming accuracy for words within each treatment condition between baseline and first follow-up assessment
The change in picture naming accuracy for trained words will be compared with the change in picture naming accuracy for words that were tested at baseline but never trained during the treatment phase.
Change in picture naming accuracy for words within each treatment condition between baseline and second follow-up assessment
The change in picture naming accuracy for trained words will be compared with the change in picture naming accuracy for words that were tested at baseline but never trained during the treatment phase.
Full Information
NCT ID
NCT02675270
First Posted
January 28, 2016
Last Updated
September 22, 2023
Sponsor
Georgetown University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute on Aging (NIA), Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT02675270
Brief Title
Rehabilitation and Prophylaxis of Anomia in Primary Progressive Aphasia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2011 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgetown University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute on Aging (NIA), Johns Hopkins University
4. Oversight
5. Study Description
Brief Summary
The goal of this study is to remediate word-finding problems in patients who have Primary Progressive Aphasia (PPA) or Alzheimer's Disease and to delay the further progression of word-finding impairment. The current approach is novel in that it contains a prophylaxis component in which the investigators attempt to strengthen neural connections that remain functional, making them more resistant to degradation as the disease progresses. While the study is specific in its targeting of word-finding problems, a successful outcome would bode well for other studies aimed at prevention or reversal of declining cognitive functions in dementia. One set of participants with PPA will receive practice with picture naming in two conditions: viewing the picture and repeating the name; and viewing the picture with its written name, plus reading and writing the name. Another set of participants with PPA or Alzheimer's Disease will be trained in two different conditions: learning about the word's semantic features (meaning); and learning about the word's lexical features (letters and sounds). Naming of pictures trained in each of these conditions will be compared, at three time intervals post-training, with naming of pictures tested before the study but never trained. It is predicted that the pairing of the picture with its written name, combined with the motor task of writing the name, will result in a greater ability to name the picture at a later date than simple practice viewing the picture and repeating the name. Furthermore, it is predicted that participants who have difficulty understanding concepts will be more likely to respond to semantic treatment, while participants who have difficulty connecting words with concepts will be more likely to respond to lexical treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Primary Progressive, Anomia, Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phonological, Orthographic, Untrained
Arm Type
Experimental
Arm Title
Semantic, Lexical, Untrained
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Phonological
Intervention Description
This treatment involves picture viewing and word repetition.
Intervention Type
Behavioral
Intervention Name(s)
Orthographic
Intervention Description
This treatment involves picture viewing, reading, and writing.
Intervention Type
Behavioral
Intervention Name(s)
Semantic
Intervention Description
This treatment involves learning about the semantic features (meaning) of each trained word.
Intervention Type
Behavioral
Intervention Name(s)
Lexical
Intervention Description
This treatment involves learning about the lexical features (letters and sounds) of each trained word.
Intervention Type
Behavioral
Intervention Name(s)
Untrained
Intervention Description
These words are not trained during the treatment phase.
Primary Outcome Measure Information:
Title
Change in picture naming accuracy for words within each treatment condition during treatment
Description
The change in picture naming accuracy for trained words will be compared with the change in picture naming accuracy for words that were tested at baseline but never trained during the treatment phase.
Time Frame
baseline, 7 months
Secondary Outcome Measure Information:
Title
Change in picture naming accuracy for words within each treatment condition between baseline and first follow-up assessment
Description
The change in picture naming accuracy for trained words will be compared with the change in picture naming accuracy for words that were tested at baseline but never trained during the treatment phase.
Time Frame
baseline, 14 months
Title
Change in picture naming accuracy for words within each treatment condition between baseline and second follow-up assessment
Description
The change in picture naming accuracy for trained words will be compared with the change in picture naming accuracy for words that were tested at baseline but never trained during the treatment phase.
Time Frame
baseline, 21 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Primary Progressive Aphasia (PPA; including Frontotemporal Dementia, Semantic Dementia, or a similar condition) or Diagnosis of Alzheimer's Disease
At least 10 years of education
Ability to follow spoken instructions
Medically stable
First language is English, or fluent in English since childhood
Willing to participate over a period of two years
Exclusion Criteria:
No history of additional neurological problems
No history of substance abuse or psychiatric problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Meyer, PhD
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Links:
URL
http://faculty.georgetown.edu/friedmar/carr.html
Description
Center for Aphasia Research and Rehabilitation website
Learn more about this trial
Rehabilitation and Prophylaxis of Anomia in Primary Progressive Aphasia
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