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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02675270
Other study ID # R01DC011317
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 2011
Est. completion date June 30, 2024

Study information

Verified date September 2023
Source Georgetown University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 84
Est. completion date June 30, 2024
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Phonological
This treatment involves picture viewing and word repetition.
Orthographic
This treatment involves picture viewing, reading, and writing.
Semantic
This treatment involves learning about the semantic features (meaning) of each trained word.
Lexical
This treatment involves learning about the lexical features (letters and sounds) of each trained word.
Untrained
These words are not trained during the treatment phase.

Locations

Country Name City State
United States Johns Hopkins University Baltimore Maryland
United States Georgetown University Medical Center Washington District of Columbia

Sponsors (4)

Lead Sponsor Collaborator
Georgetown University Johns Hopkins University, National Institute on Aging (NIA), National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline, 7 months
Secondary 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. baseline, 14 months
Secondary 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. baseline, 21 months
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