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Characterisation of Primary Progressives Aphasias (CAPP)

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ClinicalTrials.gov Identifier: NCT02297035
Recruitment Status : Unknown
Verified February 2017 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : November 21, 2014
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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).


Condition or disease Intervention/treatment Phase
Aphasia Primary Progressive Behavioral: Behavioural testing Other: Brain imaging Genetic: Genetic screening Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Linguistic, Anatomic/Metabolic and Biologic Characterisation of the Three Main Variants of Primary Progressive Aphasia : Towards the Rationale for Drug Trials and Specific Language Rehabilitations
Study Start Date : March 2012
Actual Primary Completion Date : March 2017
Estimated Study Completion Date : November 2017


Arm Intervention/treatment
Experimental: PPA patients
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
MRI, PET

Genetic: Genetic screening
APOE, Progranulin

Experimental: healthy controls
Healthy controls : Behavioural testing, Brain imaging (MRI, PET).
Behavioral: Behavioural testing
Other: Brain imaging
MRI, PET




Primary Outcome Measures :
  1. Composite outcome mesure using multiple cognitive, imaging and biological parameters [ Time Frame: D0 ]
    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).

  2. Composite outcome mesure using multiple cognitive, imaging and biological parameters [ Time Frame: 9 months ]
    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).

  3. Composite outcome mesure using multiple cognitive, imaging and biological parameters [ Time Frame: 18 months ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria A) Patients responding to current diagnostic criteria for Primary Progressive Aphasia

  1. Language disorders without important impairments of other cognitive functions
  2. 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
    • Associative agnosia and/or prosopagnosia may be present. This will allow for the inclusion of patients with multi-modal disorders of meaning (semantic dementia patients).
    • 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

Exclusion criteria A) Cognitive criteria

  • Aphasia severity rating scale of the BDAE < 3
  • MMS < 20
  • Severe disorders of executive functions, praxis or episodic memory B) MADRS ≥ 20 (major depression as defined by criteria of the DSM-IV-R) C) Patients whose mother tongue is not French D) Patients affected by of other neurological diseases than PPA or general diseases or physical problems that may impact on cognitive functioning E) Counter-indication for MRI or PET scanning (the lumbar puncture is optional / separated informed consent) F) MRI compatible with pathological processes other than PPA. A mild to moderate leucoaraiosis will not been considered as an exclusion criteria (only patients at stage > 2 will be excluded from the study) G) Non affiliation at the French healthcare system

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02297035


Contacts
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Contact: Marc Teichmann, MD, PhD 0033 (1) 42 16 75 34 marc.teichmann@psl.aphp.fr

Locations
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France
Département de Neurologie - Centre des maladies neurologiques, cognitives et comportementales Recruiting
France, France, 75003
Contact: Marc Teichmann, MD, PhD    0033 (1) 42 16 75 34      
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Marc Teichmann, MD, PhD Assitance Publique-Hopitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02297035     History of Changes
Other Study ID Numbers: P100137
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
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Language Disorders
Aphasia
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Dementia
Speech Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dementia
Brain Diseases
Central Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases