Characterization of cerebral tau aggregates with 18F-RO6958948 PET in the ALFA population.

Phase 1

• Conditions: Alzheimer's Disease; Therapeutic area: Health Care [N] - Population Characteristics [N01]

• Registration Number: EUCTR2019-004290-84-ES
• Lead Sponsor: BarcelonaBeta Brain Research Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-10
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Signature of 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 ALFAcognition study (ALFAcognition/BBRC2017) or the Barcelona?eta Dementia Prevention Research Clinic study (BBRC-DemPrev-2018).
3. Participants with an available cerebral MRI (magnetic resonance imaging) in 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 A? 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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. Individuals 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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified