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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Benson's Disease
• Intervention / Treatment: Drug: [18F]T807 PET

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • University hospital of Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2017
• Primary Completion (ACTUAL): August 27, 2019
• Study Completion (ACTUAL): November 25, 2019

Study Registration Dates

• First Submitted: January 9, 2017
• First Submitted That Met QC Criteria: January 12, 2017
• First Posted (ESTIMATE): January 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: PHAO14-CH/TEPTAU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No