NCT02675270

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

11.7 years

First QC Date

January 28, 2016

Last Update Submit

September 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in picture naming accuracy for words within each treatment condition between baseline and first follow-up assessment

    baseline, 14 months

  • Change in picture naming accuracy for words within each treatment condition between baseline and second follow-up assessment

    baseline, 21 months

Study Arms (2)

Phonological, Orthographic, Untrained

EXPERIMENTAL
Behavioral: PhonologicalBehavioral: OrthographicBehavioral: Untrained

Semantic, Lexical, Untrained

EXPERIMENTAL
Behavioral: SemanticBehavioral: LexicalBehavioral: Untrained

Interventions

PhonologicalBEHAVIORAL

This treatment involves picture viewing and word repetition.

Phonological, Orthographic, Untrained
OrthographicBEHAVIORAL

This treatment involves picture viewing, reading, and writing.

Phonological, Orthographic, Untrained
SemanticBEHAVIORAL

This treatment involves learning about the semantic features (meaning) of each trained word.

Semantic, Lexical, Untrained
LexicalBEHAVIORAL

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

Semantic, Lexical, Untrained
UntrainedBEHAVIORAL

These words are not trained during the treatment phase.

Phonological, Orthographic, UntrainedSemantic, Lexical, Untrained

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • No history of additional neurological problems
  • No history of substance abuse or psychiatric problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20057, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Aphasia, Primary ProgressiveAnomiaAlzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAphasiaSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

Study Officials

  • Aaron Meyer, PhD

    Georgetown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 5, 2016

Study Start

November 1, 2011

Primary Completion

June 30, 2023

Study Completion

June 30, 2024

Last Updated

September 25, 2024

Record last verified: 2024-09

Locations