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

NCT04482660 | Enrolling By Invitation

• 1 other identifier: tau-PET/BBRC2019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• Prevalence of cerebral tau positivity

  Prevalence of cerebral tau positivity assessed by 18F-RO6958948 PET

  at inclusion

• tau accumulation and spreading

  To predictors of tau spreading

  2 years

Study Arms (1)

PET

EXPERIMENTAL

Procedure: Positron emission tomography with 18F-RO6958948

Interventions

Positron emission tomography with 18F-RO6958948 PROCEDURE

tau PET ()

PET

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barcelonabeta Brain Research Center, Pasqual Maragall Foundation: lead
• Hoffmann-La Roche: collaborator
• Hospital Clinic of Barcelona: collaborator

Study Sites (1)

BarcelonaBeta Brain Research Center

Barcelona, Barcelona, 08005, Spain

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 22, 2020
• Study Start: March 29, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)