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Tau Brain Imaging in Typical and Atypical Alzheimer's Disease (AD) (TEPTAU)

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ClinicalTrials.gov Identifier: NCT03022968
Recruitment Status : Unknown
Verified February 2017 by University Hospital, Tours.
Recruitment status was:  Recruiting
First Posted : January 18, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Brief Summary:

Recently revised Alzheimer Disease (AD) diagnostic1described nonamnestic presentations: 1/ language presentation (logopenic progressive aphasia) 2/ visuospatial presentation (posterior cortical atrophy or PCA) and 3/ executive dysfunction. AD pathological changes may precede the clinical diagnosis of dementia of AD type for a while2. Biomarkers have been developed: biomarkers of brain amyloid-beta (Aß) (CerebroSpinal Fluid CSF concentration ßamyloid, molecular imaging with amyloid targeted PET ligands), biomarkers of neural degeneration (MRI hippocampal volume, regional metabolism as assessed by PET with [18F]-FDG) and may be used to made early detection of the neuropathology associated with AD Even if CSF biomarkers (tau, p-tau and β amyloïd are interesting to improve diagnosis of AD, they cannot provide topographic information. PET tau imaging seems to be promise to evaluate quantitative and spatial assessment of tau lesions both in AD and fronto-temporal lobar dementia.

The hypothesis of the research is that it exists a different regional pattern of tracer retention across brain regions according to clinical symptoms : temporal for logopenic aphasia and occipital for posterior cortical atrophy.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Benson's Disease Drug: [18F]T807 PET Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Tau Brain Imaging in Typical and Atypical Alzheimer's Disease (AD)
Actual Study Start Date : January 10, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : September 2018


Arm Intervention/treatment
Experimental: Alzheimer disease
[18F]T807 PET
Drug: [18F]T807 PET
Imaging with [18F]T807 PET

Experimental: Benson disease
[18F]T807 PET
Drug: [18F]T807 PET
Imaging with [18F]T807 PET

Experimental: Healthy volunteer
[18F]T807 PET
Drug: [18F]T807 PET
Imaging with [18F]T807 PET




Primary Outcome Measures :
  1. Tau density on PET imaging [ Time Frame: 3 months ]
    density pattern of aggregated tau using tau targeting PET imaging with [18F]-T807, in Standardized uptake value (SUV)

  2. Tau distribution on PET imaging [ Time Frame: 3 months ]
    distribution pattern of aggregated tau using tau targeting PET imaging with [18F]-T807, in Standardized uptake value (SUV)


Secondary Outcome Measures :
  1. p-tau CSF biomarkers [ Time Frame: inclusion ]
    p-tau dosing in pg/mL

  2. βamyloid CSF biomarkers [ Time Frame: inclusion ]
    βamyloid dosing in pg/mL

  3. Cognitive profile with Hamilton depression scale (MADRS) [ Time Frame: inclusion ]
    neuropsychological score of Hamilton depression scale (MADRS) on 30 points.

  4. Cognitive profile with Mini mental state evaluation (MMSE) [ Time Frame: inclusion ]
    neuropsychological score of Mini mental state evaluation (MMSE) on 60 points



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 50 years old and more
  • native langage: french
  • study level upper (or equal) than 7 year (considering first year of grammar-school as start)
  • correct sensory abilities (auditive device allowed) for tests
  • affiliation to social security
  • Informed, written consent form
  • for Alzheimer disease group: people with Alzheimer Disease defined as National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and the Alzheimer's Disease and Related Disorders Association (ADRDA) standards: Light to mild AD defined by Mini-Mental State Examination (MMSE) score between 15 and 25 (included)
  • for Benson disease group: Benson disease following Mendez et al (2002) and Tang Wai et al (2004) criteria
  • for healthy volunteer group: normal MMS score (more than 26 for bachelor level)

Exclusion Criteria:

  • history of disease with consequances on cognitive functioning (tumor, stroke, head trauma, etc.), cerebral surgery
  • use of alchohol and/or drug
  • anormalies in neurological exam (focal deficit) not included in the classic symptoms
  • contraindication to magnetic resonance imaging (RMI)
  • contraindication to PET: people with prolongation of QT interval or taking medication that can lead to "torsades de pointe".
  • claustrophobia
  • person with legal protection
  • exclusion period because of participation to another experimental protocol and actual participation to an experimental protocol
  • pregnant or lactating woman or able to procreate and without contraception

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): NCT03022968


Contacts
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Contact: Maria-Joao Santiago-Ribeiro, PhD +33247479729
Contact: Catherine Roussel

Locations
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France
University Hospital of Tours Recruiting
Tours, France, 37044
Contact: Maria-Joao Santiago-Ribeiro    +33247479729      
Principal Investigator: Maria-Joao Santiago-Ribeiro, PhD         
Sub-Investigator: Valerie Gissot, MD         
Sub-Investigator: Vincent Camus, PhD         
Sub-Investigator: Emilie Beaufils, MD         
Sponsors and Collaborators
University Hospital, Tours

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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT03022968     History of Changes
Other Study ID Numbers: PHAO14-CH/TEPTAU
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders