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Rehabilitation and Prophylaxis of Anomia in Primary Progressive Aphasia

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ClinicalTrials.gov Identifier: NCT02675270
Recruitment Status : Recruiting
First Posted : February 5, 2016
Last Update Posted : October 24, 2018
Sponsor:
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Aging (NIA)
Johns Hopkins University
Information provided by (Responsible Party):
Aaron Meyer, PhD, Georgetown University

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.

Condition or disease Intervention/treatment Phase
Aphasia, Primary Progressive Anomia Alzheimer Disease Behavioral: Phonological Behavioral: Orthographic Behavioral: Semantic Behavioral: Lexical Behavioral: Untrained Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : November 2011
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : June 2022


Arm Intervention/treatment
Experimental: Phonological, Orthographic, Untrained Behavioral: Phonological
This treatment involves picture viewing and word repetition.

Behavioral: Orthographic
This treatment involves picture viewing, reading, and writing.

Behavioral: Untrained
These words are not trained during the treatment phase.

Experimental: Semantic, Lexical, Untrained Behavioral: Semantic
This treatment involves learning about the semantic features (meaning) of each trained word.

Behavioral: Lexical
This treatment involves learning about the lexical features (letters and sounds) of each trained word.

Behavioral: Untrained
These words are not trained during the treatment phase.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675270


Contacts
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Contact: Sarah Snider, MA 202-687-7109 sfs24@georgetown.edu
Contact: Aaron Meyer, PhD 202-687-4196 aaron.meyer@georgetown.edu

Locations
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United States, District of Columbia
Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20057
Contact: Sarah Snider, MA    202-687-7109    sfs24@georgetown.edu   
Contact: Aaron Meyer, PhD    202-687-4196    aaron.meyer@georgetown.edu   
Principal Investigator: Aaron Meyer, PhD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Donna Tippett, MA    410-955-7895    dtippet1@jhmi.edu   
Principal Investigator: Argye Hillis, MD         
Sponsors and Collaborators
Georgetown University
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Aging (NIA)
Johns Hopkins University
Investigators
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Principal Investigator: Aaron Meyer, PhD Georgetown University

Additional Information:
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Responsible Party: Aaron Meyer, PhD, Assistant Professor, Georgetown University
ClinicalTrials.gov Identifier: NCT02675270     History of Changes
Other Study ID Numbers: R01DC011317 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Alzheimer Disease
Aphasia
Anomia
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Dementia
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases