Characterisation of Primary Progressives Aphasias

NCT02297035 | Unknown

• 1 other identifier: P100137
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

Primary progressive aphasias (PPA) represent a challenging group of degenerative language diseases that has led to growing interest in the scientific and medical community. However, a full-blown cognitive/linguistic, anatomic and biologic characterization of the three main variants remains incomplete given that the available data derive from relatively small patient samples. Such a three-fold characterisation will be an major milestone with the prospective of providing the rationale for therapeutic interventions comprising specific rehabilitations protocols and pharmacological trials. The present study addresses theses issues in the three PPA main variants through a cross-sectional and longitudinal investigation exploring 1) cognitive/linguistic features, 2) anatomic/metabolic specifications (MRI-VBM, MRI-fiber tracking, functional connectivity - MRI resting state, PET), and 3) biologic aspects (CSF biomarkers, genetic screening).

Conditions

Aphasia Primary Progressive

Outcome Measures

Primary Outcomes (3)

• Composite outcome mesure using multiple cognitive, imaging and biological parameters

  Characterisation of the three PPA variants investigating 1) the cognitive features (psycholinguistic), 2) the anatomic/metabolic substrates (structural MRI, DTI-based tractography, functional connectivity fMRI-resting state, 18FDG-PET), and 3) the biologic aspects (CSF biomarkers \[amyloid-β, tau\], genetic screening for mutations in the progranulin gene, apolipoprotein E genotyping).

  D0

• Composite outcome mesure using multiple cognitive, imaging and biological parameters

  Characterisation of the three PPA variants investigating 1) the cognitive features (psycholinguistic), 2) the anatomic/metabolic substrates (structural MRI, DTI-based tractography, functional connectivity fMRI-resting state, 18FDG-PET), and 3) the biologic aspects (CSF biomarkers \[amyloid-β, tau\], genetic screening for mutations in the progranulin gene, apolipoprotein E genotyping).

  9 months

• Composite outcome mesure using multiple cognitive, imaging and biological parameters

  Characterisation of the three PPA variants investigating 1) the cognitive features (psycholinguistic), 2) the anatomic/metabolic substrates (structural MRI, DTI-based tractography, functional connectivity fMRI-resting state, 18FDG-PET), and 3) the biologic aspects (CSF biomarkers \[amyloid-β, tau\], genetic screening for mutations in the progranulin gene, apolipoprotein E genotyping).

  18 months

Study Arms (2)

PPA patients

EXPERIMENTAL

Experimental (Patients responding to current diagnostic criteria for Primary Progressive Aphasia (PPA) patients) : Behavioural testing, Brain imaging (MRI, PET), Genetic screening (APOE, Progranulin)

Behavioral: Behavioural testing; Other: Brain imaging; Genetic: Genetic screening

healthy controls

EXPERIMENTAL

Healthy controls : Behavioural testing, Brain imaging (MRI, PET).

Behavioral: Behavioural testing; Other: Brain imaging

Interventions

Behavioural testing BEHAVIORAL

PPA patients; healthy controls

Brain imaging OTHER

MRI, PET

PPA patients; healthy controls

Genetic screening GENETIC

APOE, Progranulin

PPA patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Language disorders without important impairments of other cognitive functions
• Insidious onset and gradual progression
• Diagnostic criteria for non fluent PPA
• Non fluent language out-put
• Phonemic paraphasias and/or agrammatism
• Relative preservation of speech comprehension
• Diagnostic criteria for fluent PPA
• Fluent language out-put
• Impairment of the access to word meanings leading to comprehension disorders and naming deficits
• Diagnostic criteria for logopenic PPA
• Speech out-put with frequent interruptions due to word finding deficits
• Disorders of sentence comprehension and repetition due to impairment of working memory B) Patients at age of majority C) Patients having given informed and written consent

You may not qualify if:

• Aphasia severity rating scale of the BDAE \< 3
• MMS \< 20

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Département de Neurologie - Centre des maladies neurologiques, cognitives et comportementales

France, 75003, France

RECRUITING

MeSH Terms

Conditions

Pick Disease of the Brain

Interventions

Neuroimaging; Genetic Testing

Condition Hierarchy (Ancestors)

Frontotemporal Dementia; Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques; Clinical Laboratory Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Marc Teichmann, MD, PhD

  Assitance Publique-Hopitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Teichmann, MD, PhD

CONTACT

0033 (1) 42 16 75 34; marc.teichmann@psl.aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: November 21, 2014
• Study Start: March 1, 2012
• Primary Completion: March 1, 2017
• Study Completion: November 1, 2017
• Last Updated: August 14, 2017

Record last verified: 2017-02

Locations

FR (1)