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

Primary Purpose

Alzheimer Disease, Benson's Disease

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
[18F]T807 PET
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital of Tours

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Alzheimer disease

Benson disease

Healthy volunteer

Arm Description

[18F]T807 PET

[18F]T807 PET

[18F]T807 PET

Outcomes

Primary Outcome Measures

Tau density on PET imaging
density pattern of aggregated tau using tau targeting PET imaging with [18F]-T807, in Standardized uptake value (SUV)
Tau distribution on PET imaging
distribution pattern of aggregated tau using tau targeting PET imaging with [18F]-T807, in Standardized uptake value (SUV)

Secondary Outcome Measures

p-tau CSF biomarkers
p-tau dosing in pg/mL
βamyloid CSF biomarkers
βamyloid dosing in pg/mL
Cognitive profile with Hamilton depression scale (MADRS)
neuropsychological score of Hamilton depression scale (MADRS) on 30 points.
Cognitive profile with Mini mental state evaluation (MMSE)
neuropsychological score of Mini mental state evaluation (MMSE) on 60 points

Full Information

First Posted
January 9, 2017
Last Updated
September 8, 2022
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT03022968
Brief Title
Tau Brain Imaging in Typical and Atypical Alzheimer's Disease (AD)
Acronym
TEPTAU
Official Title
Tau Brain Imaging in Typical and Atypical Alzheimer's Disease (AD)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 10, 2017 (Actual)
Primary Completion Date
August 27, 2019 (Actual)
Study Completion Date
November 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Benson's Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alzheimer disease
Arm Type
Experimental
Arm Description
[18F]T807 PET
Arm Title
Benson disease
Arm Type
Experimental
Arm Description
[18F]T807 PET
Arm Title
Healthy volunteer
Arm Type
Experimental
Arm Description
[18F]T807 PET
Intervention Type
Drug
Intervention Name(s)
[18F]T807 PET
Intervention Description
Imaging with [18F]T807 PET
Primary Outcome Measure Information:
Title
Tau density on PET imaging
Description
density pattern of aggregated tau using tau targeting PET imaging with [18F]-T807, in Standardized uptake value (SUV)
Time Frame
3 months
Title
Tau distribution on PET imaging
Description
distribution pattern of aggregated tau using tau targeting PET imaging with [18F]-T807, in Standardized uptake value (SUV)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
p-tau CSF biomarkers
Description
p-tau dosing in pg/mL
Time Frame
inclusion
Title
βamyloid CSF biomarkers
Description
βamyloid dosing in pg/mL
Time Frame
inclusion
Title
Cognitive profile with Hamilton depression scale (MADRS)
Description
neuropsychological score of Hamilton depression scale (MADRS) on 30 points.
Time Frame
inclusion
Title
Cognitive profile with Mini mental state evaluation (MMSE)
Description
neuropsychological score of Mini mental state evaluation (MMSE) on 60 points
Time Frame
inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
University Hospital of Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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