Study of a new positron emission tomography (PET) tracer for the study of neurodegenerative conditions characterized by the cerebral accumulation of the protein tau.
- Conditions
- TaupatíasTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-004656-22-ES
- Lead Sponsor
- Institut de Recerca HSCSP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion criteria for patients: (1) Men and women over eighteen years-old; (2) evaluated at the Memory unit of the Hospital de la Santa Creu i Sant Pau; (3) that meet current clinical criteria for Alzheimer disease dementia, mild cognitive impairment due to Alzheimer disease, DS related dementia, nfPPA, bvFTD, PSP and CBD; (4) and given written informed consent.
Inclusion criteria for healthy controls: (1) Men and women over eighteen years old; (2) currently enrolled in other clinical studies of the Memory unit at the Hospital de la Santa Creu i Sant Pau; (3) without cognitive complaints; (4) a normal performance on neuropsychological evaluation (adjusted by age and education); (5) and given written informed consent.
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
General exclusion criteria: (1) Non-compliance of inclusion criteria; (2) Diagnosis of major depression; (3) Previous stroke; (4) Inability to perform lumbar puncture, magnetic resonance imaging or neuropsychological evaluation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of [18F]THK-5351 to detect Tau pathology in patients with AD, DS related dementia, nfPPA, bvFTD, PSP and CBD.;Secondary Objective: To evaluate the safety of [18F]THK-5351 in healthy subjects, as well as in patients with AD, DS related dementia, nfPPA, bvFTD, PSP and CBD.;Primary end point(s): Standarized uptake value ratios (SUVR) of generated images on PET-TC (Philips Gemini TF or en Philips Vereos Digital) during the first 90 minutes following the administration of [18F]THK-5351.;Timepoint(s) of evaluation of this end point: 90 minutes
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Adverse effects will be systematically evaluated and registered during the first 24 hours after the administration of the tracer.;Timepoint(s) of evaluation of this end point: 24 hours