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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Healthy; Mild Cognitive Impairment
• Intervention / Treatment: Procedure: Positron emission tomography with 18F-RO6958948

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08005
    • BarcelonaBeta Brain Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. To sign the study informed consent form approved by the corresponding authorities.
2. 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).
3. Participants with an available cerebral MRI within the last 12 months not suggestive of radiological incidental findings constituting an exclusion criterion.
4. 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.
5. Known AB and tau status.
6. Good knowledge of the language and being literate.
7. Female participants should be post-menopausal or present a negative pregnancy test at the moment of PET acquisition.

Exclusion Criteria:

1. 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.
2. Participants with visual and/or hearing impairment.
3. History of encephalitis, ictus or seizures excluding feverish convulsions during childhood, as assessed in the BBRC-sponsored studies specified above.
4. Severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumour (metastasis/brain cancer) as verified by MRI.
5. 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.
6. Clinically relevant renal or hepatic insufficiency.
7. Any other clinically important condition that may jeopardize the study or be dangerous for the participant.
8. Active drug or alcohol abuse, as assessed in the BBRC-sponsored studies specified above.
9. Previous intolerance to PET studies or known hypersensitivity to 18F-RO6958948.
10. Being pregnant or breast-feeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PET	Procedure: Positron emission tomography with 18F-RO6958948; tau PET ()

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
• Collaborators: Hoffmann-La Roche; Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 20, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (Actual): July 22, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: tau-PET/BBRC2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No