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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03022968
Recruitment Status : Active, not recruiting
First Posted : January 18, 2017
Last Update Posted : September 26, 2019
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)
Actual Enrollment : 17 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
Actual Primary Completion Date : August 27, 2019
Estimated Study Completion Date : November 25, 2019

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

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 identifier (NCT number): NCT03022968

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University Hospital of Tours
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Tours
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Responsible Party: University Hospital, Tours Identifier: NCT03022968    
Other Study ID Numbers: PHAO14-CH/TEPTAU
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: May 2019
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
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders