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

Alzheimer Disease Clinical Trial

— TEPTAU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03022968
• Other study ID #: PHAO14-CH/TEPTAU
• Status: Completed
• Phase: Phase 2
• Start date: January 10, 2017
• Est. completion date: November 25, 2019

Study information

• Verified date: May 2019
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: November 25, 2019
• Est. primary completion date: August 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Benson's Disease

Intervention

Drug:
• [18F]T807 PET
Imaging with [18F]T807 PET

Locations

Country	Name	City	State
France	University Hospital of Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	p-tau CSF biomarkers	p-tau dosing in pg/mL	inclusion
Secondary	ßamyloid CSF biomarkers	ßamyloid dosing in pg/mL	inclusion
Secondary	Cognitive profile with Hamilton depression scale (MADRS)	neuropsychological score of Hamilton depression scale (MADRS) on 30 points.	inclusion
Secondary	Cognitive profile with Mini mental state evaluation (MMSE)	neuropsychological score of Mini mental state evaluation (MMSE) on 60 points	inclusion