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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, 2019
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

Tracking Information
First Submitted Date  ICMJE January 28, 2016
First Posted Date  ICMJE February 5, 2016
Last Update Posted Date October 24, 2019
Actual Study Start Date  ICMJE November 2011
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
Change in picture naming accuracy for words within each treatment condition (Phonological, Orthographic, and Untrained) during treatment [ Time Frame: baseline, 7 months ]
The change in picture naming accuracy for words trained in the phonological or orthographic condition 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 History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2017)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
  • Change in picture naming accuracy for words within each treatment condition (Phonological, Orthographic, and Untrained) between baseline and first follow-up assessment [ Time Frame: baseline, 14 months ]
    The change in picture naming accuracy for words trained in the phonological or orthographic condition 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 (Phonological, Orthographic, and Untrained) between baseline and second follow-up assessment [ Time Frame: baseline, 21 months ]
    The change in picture naming accuracy for words trained in the phonological or orthographic condition will be compared with the change in picture naming accuracy for words that were tested at baseline but never trained during the treatment phase.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rehabilitation and Prophylaxis of Anomia in Primary Progressive Aphasia
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Aphasia, Primary Progressive
  • Anomia
  • Alzheimer Disease
Intervention  ICMJE
  • Behavioral: Phonological
    This treatment involves picture viewing and word repetition.
  • Behavioral: Orthographic
    This treatment involves picture viewing, reading, and writing.
  • 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.
Study Arms  ICMJE
  • Experimental: Phonological, Orthographic, Untrained
    Interventions:
    • Behavioral: Phonological
    • Behavioral: Orthographic
    • Behavioral: Untrained
  • Experimental: Semantic, Lexical, Untrained
    Interventions:
    • Behavioral: Semantic
    • Behavioral: Lexical
    • Behavioral: Untrained
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 19, 2017)
85
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2016)
45
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sarah Snider, MA 202-687-7109 sfs24@georgetown.edu
Contact: Aaron Meyer, PhD 202-687-4196 aaron.meyer@georgetown.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02675270
Other Study ID Numbers  ICMJE R01DC011317( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aaron Meyer, PhD, Georgetown University
Study Sponsor  ICMJE Georgetown University
Collaborators  ICMJE
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • National Institute on Aging (NIA)
  • Johns Hopkins University
Investigators  ICMJE
Principal Investigator: Aaron Meyer, PhD Georgetown University
PRS Account Georgetown University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP