Alzheimer DiseasePhase 2TEPTAUNCT03022968
Tau Brain Imaging in Typical and Atypical Alzheimer's Disease (AD)
A Phase 2 study testing [18F]T807 PET in people with Alzheimer Disease and Benson's Disease, run by University Hospital, Tours at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Benson's Disease
- What is being tested?
- [18F]T807 PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2017to 25 Nov 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Alzheimer Disease, Benson's Disease
- Being tested
- [18F]T807 PET
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]T807 PETDrug
Imaging with [18F]T807 PET
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer disease | Experimental | [18F]T807 PET Receives: Drug: [18F]T807 PET |
| Benson disease | Experimental | [18F]T807 PET Receives: Drug: [18F]T807 PET |
| Healthy volunteer | Experimental | [18F]T807 PET Receives: Drug: [18F]T807 PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tau density on PET imaging
density pattern of aggregated tau using tau targeting PET imaging with [18F]-T807, in Standardized uptake value (SUV)
Measured: 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)
Measured: 3 months
Secondary outcomes (4)
p-tau CSF biomarkers
p-tau dosing in pg/mL
Measured: inclusion
βamyloid CSF biomarkers
βamyloid dosing in pg/mL
Measured: inclusion
Cognitive profile with Hamilton depression scale (MADRS)
neuropsychological score of Hamilton depression scale (MADRS) on 30 points.
Measured: inclusion
Cognitive profile with Mini mental state evaluation (MMSE)
neuropsychological score of Mini mental state evaluation (MMSE) on 60 points
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start10 Jan 2017
- Primary completion27 Aug 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022968
- Sponsor's protocol ID
- PHAO14-CH/TEPTAU
- Acronym
- TEPTAU
- Status last verified
- May 2019
- First submitted
- 9 Jan 2017
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tau Brain Imaging in Typical and Atypical Alzheimer's Disease (AD)
- ClinicalTrials.gov ID
- NCT03022968
- Acronym / sponsor ID
- TEPTAU / PHAO14-CH/TEPTAU
- Conditions
- Alzheimer Disease, Benson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 27 Aug 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alzheimer disease | Experimental | Drug: [18F]T807 PET[18F]T807 PET |
| Benson disease | Experimental | Drug: [18F]T807 PET[18F]T807 PET |
| Healthy volunteer | Experimental | Drug: [18F]T807 PET[18F]T807 PET |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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".
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]T807 PETImaging with [18F]T807 PET | Drug | Alzheimer disease, Benson disease, Healthy volunteer |
Primary outcome
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)
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)
4 secondary outcomes
p-tau CSF biomarkers
Time frame: inclusion
βamyloid CSF biomarkers
Time frame: inclusion
Cognitive profile with Hamilton depression scale (MADRS)
Time frame: inclusion
Cognitive profile with Mini mental state evaluation (MMSE)
Time frame: inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [18F]T807 PET in people with Alzheimer Disease and Benson's Disease, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tau density on PET imaging (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022.