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

Primary Purpose

Healthy, Mild Cognitive Impairment

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Positron emission tomography with 18F-RO6958948
Sponsored by
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • BarcelonaBeta Brain Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET

Arm Description

Outcomes

Primary Outcome Measures

Prevalence of cerebral tau positivity
Prevalence of cerebral tau positivity assessed by 18F-RO6958948 PET
tau accumulation and spreading
To predictors of tau spreading

Secondary Outcome Measures

Full Information

First Posted
July 20, 2020
Last Updated
November 8, 2022
Sponsor
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Collaborators
Hoffmann-La Roche, Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT04482660
Brief Title
Characterization of Cerebral Tau Aggregates With 18F-RO6958948 PET in the ALFA Population
Official Title
Characterization of Cerebral Tau Aggregates With 18F-RO6958948 PET in the ALFA Population
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Collaborators
Hoffmann-La Roche, Hospital Clinic of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Mild Cognitive Impairment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PET
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Positron emission tomography with 18F-RO6958948
Intervention Description
tau PET ()
Primary Outcome Measure Information:
Title
Prevalence of cerebral tau positivity
Description
Prevalence of cerebral tau positivity assessed by 18F-RO6958948 PET
Time Frame
at inclusion
Title
tau accumulation and spreading
Description
To predictors of tau spreading
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
BarcelonaBeta Brain Research Center
City
Barcelona
ZIP/Postal Code
08005
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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

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