Imaging of tau in patients with dementia

• Register: EUCTR
• Last refreshed on: 2 October 2017
• Main ID: EUCTR2015-005604-29-NL
• Date of registration: 20/01/2016
• Prospective Registration: Yes
• Primary sponsor: VU University Medical Center
• Public title: Imaging of tau in patients with dementia
• Scientific title: Tau-imaging in tauopathies; Alzheimer’s disease and non-AD dementias - TITAN
• Date of first enrolment: 16/11/2016
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-005604-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Control Subjects Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Netherlands

Contacts

• Name: Dept. Radiology & Nuclear Medicine
• Affiliation: VU University Medical Center

• Name: Dept. Radiology & Nuclear Medicine
• Affiliation: VU University Medical Center

Key inclusion & exclusion criteria

Inclusion criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- At least 50 years of age
- Subjects must, in the opinion of the principal investigator/attending neurologist, be able to tolerate the [18F]AV1451 PET scan procedures and be competent to make a well informed decision to participate in this study.

Additional inclusion criteria per diagnostic group:
For probable AD dementia patients;
- A diagnosis of probable AD with at least intermediate likelihood according to recently proposed NIA-AA criteria. This will be determined using PET and/or CSF evidence of Aß deposition.

For “MCI due to AD” patients;
- Patients must meet clinical criteria for MCI, and;
present with positive Aß biomarkers on PET and/or CSF.For patients with a dementia syndrome likely induced by tauopathy;
For DLB patients;
- Patients must be included in the DEvELOP (protocol number 15/548)
- Subjects must, in the opinion of the principal investigator/attending neurologist, be able to tolerate the [18F] FDG PET scan procedures

For controls;
- No objective evidence of cognitive impairment as assessed by a multidisciplinary specialist team;
- normal MRI;

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160

Exclusion criteria:
No MRI available or possible
Abnormalities on MRI which may interfere with PET image assessment:
Is or may become pregnant in the 90 days after the PET scan
Relevant history of drug allergy or hypersensitivity
Has ever recieved a tau and/or amyloid-beta targetting agent
Has been injected with a previously administered radiopharmaceutical within 6 terminal half-lives OR the total yearly radiation exposure exceeds 10 mSv;
Has current clinically significant cardiovascular disease or clinically significant abnormalities on screening ECG (e.g. QTc > 450 msec)
Has a history of moderate or severe traumatic brain injury (TBI).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Dementia inducing Alzheimer's disease, Frontotemporal dementia (FTD) and Lewy Body Dementia (DLB)
MedDRA version: 20.0 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: LLT Classification code 10057095 Term: Diffuse Lewy body disease System Organ Class: 100000072901
MedDRA version: 20.0 Level: PT Classification code 10068968 Term: Frontotemporal dementia System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: LLT Classification code 10012283 Term: Dementia due to other general medical conditions System Organ Class: 100000014717

Intervention(s)

Product Name: 18F-AV-1451
Pharmaceutical Form: Solution for injection
INN or Proposed INN: not applicable
CAS Number: 152201-90-6
Current Sponsor code: 18F-Av-1451
Other descriptive name: T807
Concentration unit: MBq megabecquerel(s)
Concentration type: equal
Concentration number: 240-

Primary Outcome(s)

Secondary Objective: To examine the (regional) binding of 18F-AV-1451 across tauopathies, and the relationships between tracer binding, neurodegeneration and symptoms.
To explore the predictive value of [18F]AV1451 binding for change over time in neuropsychological performance.

Timepoint(s) of evaluation of this end point: Continious PET scan from 0-60 and 80-130 minutes post injection at baseline

Main Objective: To test the novel PET-tracer 18F-AV-1451 for tau pathology as a diagnostic and prognostic marker in tauopathies

Primary end point(s): Quantification and distribution of 18F-AV-1451 specific binding.

Secondary Outcome(s)

Secondary end point(s): - Neuropsychological performance (over time);
- Gray matter volumes on MRI
- CSF protein levels (tau, ptau and Aß42);
- Aß-PET tracer binding.
- FDG-PET binding

Timepoint(s) of evaluation of this end point: - Neuropsychological performance (over time) at baseline and follow-up after one year
- Gray matter volumes on MRI taken as part of clinical dementia screening.
- CSF protein levels (tau, ptau and Aß42) obtained by a lumbar punction performed as part of clinical dementia screening
- Amyloid beta-PET tracer binding obtained (where applicable) from previously performed amyloid-beta PET scans with 18F-Florbetapir, 18F-Florbetaben or 11C-Pittsburgh compound B

Secondary ID(s)

15-17

Source(s) of Monetary Support

Avid Radiopharmaceuticals