Study of a new positron emission tomography (PET) tracer for the study of neurodegenerative conditions characterized by the cerebral accumulation of the protein tau.

Pilot study of the [18F]THK-5351 positron emission tomography (PET) tracer in different tauopathies.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004656-22-ES

Enrollment

Registered

2016-02-24

Start date

2017-10-10

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Taupatías

Interventions

Product Name: [18F]THK-5351 Product Code: [18F]THK-5351 Pharmaceutical Form: Radiopharmaceutical precursor INN or Proposed INN: [18F]THK-5351

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Spain

Contacts

Public ContactUICEC Sant Pau

Institut de Recerca HSCSP

epenag@santpau.cat34935537634

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026