Characterization of Cerebral Tau Aggregates With 18F-RO6958948 PET in the ALFA Population

Обзор

This study will characterize tau tracer retention by Positron Emission Tomography (PET) as a function of amyloid levels transversally and longitudinally.

Подробное описание

CROSS-SECTIONAL OBJECTIVES

* To measure 18F-RO6958948 retention in selected participants of ALFA-related studies as a function of amyloid levels. * To study the relation between 18F-RO6958948 retention and amyloid levels. * To characterize imaging correlates as a function of tau and amyloid levels. * To study the role of tau retention on cognitive performance. * To define predictors of tau retention.

LONGITUDINAL OBJECTIVES

* To measure tau accumulation and spreading in participants of the ALFA-related studies of BBRC as a function of baseline amyloid levels. * To study the dynamic relation between tau spreading and amyloid levels longitudinally. * To define predictors of tau spreading.

Вмешательства

• Процедура Positron emission tomography with 18F-RO6958948
  tau PET ()

Первичные конечные точки

• Prevalence of cerebral tau positivity [Срок оценки: at inclusion]
• tau accumulation and spreading [Срок оценки: 2 years]

Критерии участия

Критерии включения

• To sign the study informed consent form approved by the corresponding authorities.
• Men and women that have participated in a BBRC-sponsored study, including the ALFA project (STUDY 45-65 FPM/2012), the ALFA+ cohort study (ALFA - FPM - 0311), the ALFA cognition study (ALFAcognition/BBRC2017) or the BarcelonaBeta Dementia Prevention Research Clinic study (BBRC-DemPrev-2018).
• Participants with an available cerebral MRI within the last 12 months not suggestive of radiological incidental findings constituting an exclusion criterion.
• Known cognitive status based on the cognitive workup of the BBRC-sponsored studies specified above. Cognitive status should have been determined within the last 12 months.
• Known AB and tau status.
• Good knowledge of the language and being literate.
• Female participants should be post-menopausal or present a negative pregnancy test at the moment of PET acquisition.

Критерии исключения

• Presence of clinically relevant psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria: major depressive disorder, generalized anxiety disorder, schizophrenia and bipolar disorder, as assessed in the BBRC-sponsored studies specified above.
• Participants with visual and/or hearing impairment.
• History of encephalitis, ictus or seizures excluding feverish convulsions during childhood, as assessed in the BBRC-sponsored studies specified above.
• Severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumour (metastasis/brain cancer) as verified by MRI.
• Previous participation in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening and/or administration of a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study.
• Clinically relevant renal or hepatic insufficiency.
• Any other clinically important condition that may jeopardize the study or be dangerous for the participant.
• Active drug or alcohol abuse, as assessed in the BBRC-sponsored studies specified above.
• Previous intolerance to PET studies or known hypersensitivity to 18F-RO6958948.
• Being pregnant or breast-feeding.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Испания · 1 центр

• BarcelonaBeta Brain Research Center — Barcelona

Идентификаторы

NCT: NCT04482660 · tau-PET/BBRC2019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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