Aphasia, Primary ProgressiveNCT02675270
Rehabilitation and Prophylaxis of Anomia in Primary Progressive Aphasia
A study testing Phonological, Orthographic and Semantic in people with Aphasia, Primary Progressive and Anomia, run by Georgetown University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Aphasia, Primary Progressive, Anomia, Alzheimer Disease
- What is being tested?
- Phonological, Orthographic and Semantic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2011to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No history of additional neurological problems
- No history of substance abuse or psychiatric problems
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Georgetown University Medical Center
Washington D.C., District of Columbia, 20057
About this study
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.
- Conditions
- Aphasia, Primary Progressive, Anomia, Alzheimer Disease
- Being tested
- Phonological, Orthographic, Semantic, Lexical, Untrained
- Medical subject headings
- Aphasia, Primary Progressive, Anomia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhonologicalBehavioural
This treatment involves picture viewing and word repetition.
OrthographicBehavioural
This treatment involves picture viewing, reading, and writing.
SemanticBehavioural
This treatment involves learning about the semantic features (meaning) of each trained word.
LexicalBehavioural
This treatment involves learning about the lexical features (letters and sounds) of each trained word.
UntrainedBehavioural
These words are not trained during the treatment phase.
| Study group | Role | What they receive |
|---|---|---|
| Phonological, Orthographic, Untrained | Experimental | Not described Receives: Behavioral: Phonological; Behavioral: Orthographic; Behavioral: Untrained |
| Semantic, Lexical, Untrained | Experimental | Not described Receives: Behavioral: Semantic; Behavioral: Lexical; Behavioral: Untrained |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 7 months
Secondary outcomes (2)
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.
Measured: baseline, 14 months
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.
Measured: baseline, 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startNov 2011
- Primary completion30 Jun 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aphasia, Primary ProgressiveStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute on Aging (NIA), Johns Hopkins University
- Responsible party
- Principal investigator, Aaron Meyer, PhD, Georgetown University
- Investigators
- Aaron Meyer, PhD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675270
- Sponsor's protocol ID
- R01DC011317
- Status last verified
- Sep 2024
- First submitted
- 28 Jan 2016
- Last updated
- 25 Sep 2024
- Results posted
- No
Publications
Suh S, Friedman RB, Meyer AM, Snider SF, Sebastian R, Tippett DC. Picture Description and Functional Communication Rating Correlates in Variants of Primary Progressive Aphasia. Aphasiology. 2025 May 28:10.1080/02687038.2025.2510327. doi: 10.1080/02687038.2025.2510327. Online ahead of print.
PubMed 40857539
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation and Prophylaxis of Anomia in Primary Progressive Aphasia
- ClinicalTrials.gov ID
- NCT02675270
- Acronym / sponsor ID
- R01DC011317
- Conditions
- Aphasia, Primary Progressive, Anomia, Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute on Aging (NIA), Johns Hopkins University
- Study start
- Nov 2011 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phonological, Orthographic, Untrained | Experimental | Behavioral: Phonological, Behavioral: Orthographic, Behavioral: Untrained |
| Semantic, Lexical, Untrained | Experimental | Behavioral: Semantic, Behavioral: Lexical, Behavioral: Untrained |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- No history of additional neurological problems
- No history of substance abuse or psychiatric problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhonologicalThis treatment involves picture viewing and word repetition. | Behavioural | Phonological, Orthographic, Untrained |
| OrthographicThis treatment involves picture viewing, reading, and writing. | Behavioural | Phonological, Orthographic, Untrained |
| SemanticThis treatment involves learning about the semantic features (meaning) of each trained word. | Behavioural | Semantic, Lexical, Untrained |
| LexicalThis treatment involves learning about the lexical features (letters and sounds) of each trained word. | Behavioural | Semantic, Lexical, Untrained |
| UntrainedThese words are not trained during the treatment phase. | Behavioural | Phonological, Orthographic, Untrained, Semantic, Lexical, Untrained |
Primary outcome
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.
2 secondary outcomes
Change in picture naming accuracy for words within each treatment condition between baseline and first follow-up assessment
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Derived from this study: PubMed 40857539Suh S, Friedman RB, Meyer AM, Snider SF, Sebastian R, Tippett DC. Picture Description and Functional Communication Rating Correlates in Variants of Primary Progressive Aphasia. Aphasiology. 2025 May 28:10.1080/02687038.2025.2510327. doi: 10.1080/02687038.2025.2510327. Online ahead of print.
- Center for Aphasia Research and Rehabilitation websiteLink provided by the sponsor.
Related trials for Aphasia, Primary Progressive
Enrolling by invitationPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen A: AADvac1
PSP - Progressive Supranuclear Palsy
Enrolling by invitationPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen B: LM11A-31
PSP - Progressive Supranuclear Palsy
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Not yet recruitingObservational study
Ultra-high-performance Positron Emission Tomography (PET) of Synaptic Density, Reactive Astrogliosis and Tau in Alzheimer's Disease
Alzheimer's Disease, Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Meyer, PhD principal investigator
Georgetown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phonological, Orthographic and Semantic in people with Aphasia, Primary Progressive and Anomia, run by Georgetown University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in picture naming accuracy for words within each treatment condition during treatment (time frame: baseline, 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02675270, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.