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

• Sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04482660
• Collaborator: Hoffmann-La Roche (Industry), Hospital Clinic of Barcelona (Other)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 48.1
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy; Mild Cognitive Impairment	Procedure: Positron emission tomography with 18F-RO6958948	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Characterization of Cerebral Tau Aggregates With 18F-RO6958948 PET in the ALFA Population
• Actual Study Start Date: Mar 29, 2021
• Anticipated Primary Completion Date: Mar 31, 2024
• Anticipated Study Completion Date: Mar 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Prevalence of cerebral tau positivity [at inclusion]

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

2. tau accumulation and spreading [2 years]

   To predictors of tau spreading

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BarcelonaBeta Brain Research Center	Barcelona		Spain	08005

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
• ClinicalTrials.gov Identifier: NCT04482660
• Other Study ID Numbers: tau-PET/BBRC2019
• First Posted: Jul 22, 2020
• Last Update Posted: Sep 16, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cognitive Dysfunction

Study Results

No Results Posted as of Sep 16, 2021