- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02675270
Rehabilitation and Prophylaxis of Anomia in Primary Progressive Aphasia
September 22, 2023 updated by: Aaron Meyer, PhD, Georgetown University
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20057
- Georgetown University Medical Center
-
-
Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phonological, Orthographic, Untrained
|
This treatment involves picture viewing and word repetition.
This treatment involves picture viewing, reading, and writing.
These words are not trained during the treatment phase.
|
Experimental: Semantic, Lexical, Untrained
|
These words are not trained during the treatment phase.
This treatment involves learning about the semantic features (meaning) of each trained word.
This treatment involves learning about the lexical features (letters and sounds) of each trained word.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in picture naming accuracy for words within each treatment condition during treatment
Time Frame: baseline, 7 months
|
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.
|
baseline, 7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in picture naming accuracy for words within each treatment condition between baseline and first follow-up assessment
Time Frame: baseline, 14 months
|
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.
|
baseline, 14 months
|
Change in picture naming accuracy for words within each treatment condition between baseline and second follow-up assessment
Time Frame: baseline, 21 months
|
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.
|
baseline, 21 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Aaron Meyer, PhD, Georgetown University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2011
Primary Completion (Actual)
June 30, 2023
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
January 28, 2016
First Submitted That Met QC Criteria
February 2, 2016
First Posted (Estimated)
February 5, 2016
Study Record Updates
Last Update Posted (Actual)
September 25, 2023
Last Update Submitted That Met QC Criteria
September 22, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Dementia
- Tauopathies
- Language Disorders
- Communication Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Alzheimer Disease
- Aphasia
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
- Anomia
Other Study ID Numbers
- R01DC011317 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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