Clincosm LogoSign in Get a demo

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

Sponsor
University Hospital, Tours (Other)
Overall Status
Unknown status
CT.gov ID
NCT03022968
Collaborator
(none)
17
Enrollment
1
Location
3
Arms
34.5
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: [18F]T807 PET
 Phase 2

Study Design

Study Type:
Interventional
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 :
Jan 10, 2017
Actual Primary Completion Date :
Aug 27, 2019
Anticipated Study Completion Date :
Nov 25, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Tau density on PET imaging [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 [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 [inclusion]

    p-tau dosing in pg/mL

  2. βamyloid CSF biomarkers [inclusion]

    βamyloid dosing in pg/mL

  3. Cognitive profile with Hamilton depression scale (MADRS) [inclusion]

    neuropsychological score of Hamilton depression scale (MADRS) on 30 points.

  4. Cognitive profile with Mini mental state evaluation (MMSE) [inclusion]

    neuropsychological score of Mini mental state evaluation (MMSE) on 60 points

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital of Tours Tours France 37044

Sponsors and Collaborators

  • University Hospital, Tours

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT03022968
Other Study ID Numbers:
  • PHAO14-CH/TEPTAU
First Posted:
Jan 18, 2017
Last Update Posted:
Sep 26, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Alzheimer Disease

Study Results

No Results Posted as of Sep 26, 2019