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NCT06739967Recruiting

Speech and Language Interventions for Italian People With PPA

Speech and Language-Tailored Interventions for People With Primary Progressive Aphasia

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

Primary progressive aphasia (PPA) is an umbrella term used to refer to several clinical variants that manifest as an insidious deterioration of speech/language skills, usually due to frontotemporal lobar degeneration and/or Alzheimer's disease. Consensus criteria have been proposed by an international community regarding the sub-classification of PPA into three variants: (1) semantic variant PPA, characterized by impaired confrontation naming and single-word comprehension; (2) logopenic variant PPA), characterised by word-finding difficulties and sentence repetition deficits; and (3) non-fluent variant, characterised by agrammatism with or without apraxia of speech. Speech and language therapists (SLTs) play a crucial role in the diagnostic process and in setting a therapeutic path along with monitoring the evolution of the clinical picture. Despite growing evidence supporting the benefits of speech-language intervention, the frequency with which individuals with PPA are referred for speech and language services, is suboptimal likely due to skepticism regarding the value of speech and language therapy in the context of neurodegeneration, the scarcity of SLTs with expertise in the treatment of PPA, the lack of awareness regarding the role of the SLT amongst referrers, and the geographical barriers that impede access to in-person speech and language services. In Italy, patients with PPA are rarely offered treatment options due to a lack of understanding of the disorder on the part of health professionals and erroneous assumptions regarding the utility of treatment in patients facing a worsening prognosis. The primary aim of this pilot study is to develop tailored speech and language interventions for patients with different variants of PPA by addressing their linguistic and cognitive difficulties. Secondly, to explore the intervention's effect also on untreated tasks and assess the long-term maintenance of the proposed interventions by monitoring patients for up to six months. Finally, in each PPA variant, the investigators aim to investigate which variables among the sociodemographic, clinical, linguistic/cognitive, and brain MRI features at baseline predict successful clinical results, as well as which structural and functional brain changes are associated with speech and language improvements.

Status (registry)
Recruiting
Study type
Observational
Enrollment
30 (estimated)
First submitted
6 Dec 2024
Start date
1 Sept 2024
Primary completion date
28 Feb 2027
Lead sponsor
Istituti Clinici Scientifici Maugeri SpA
NCT number
NCT06739967

What you commit to

  • Study type: Observational
  • Planned participants: 30
  • From 1 Sept 2024 to the primary completion date, 28 Feb 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent participation in other pharmacological and non-pharmacological experimental studies

Other illness

  • Presence of other neurological or psychiatric diseases, including cerebrovascular disease

Other

  • Mini-Mental State Exam (MMSE) Score \<15
  • Severe and uncorrected hearing loss or visual disturbances
  • Inability to repeat multi-syllable words (4 syllables)

Who the study is looking for

  • Diagnosis of PPA according to the current clinical criteria (Gorno-Tempini et al., 2011)
  • Mild PPA defined using the Progressive Aphasia Severity Scale (PASS)
  • Age between 40 and 85 years
  • Patients with Italian mother tongue
  • Patients with the ability to sign the informed consent
  • Patients with the ability to comply with the study procedures
  • Patients with stable pharmacological treatment for at least 4 weeks.

Age in the registry: 40 years to 85 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Istituti Clinici Scientifici Maugeri IRCCS
Coordinator of this site? Confirm its status
BariItalyRecruiting
IRCCS Ospedale San Raffaele
Coordinator of this site? Confirm its status
MilanItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.