PET imaging study of the brain tau deposit in individuals with subjective cognitivedecline and mild cognitive impairment: FACEHBI cohort.

Phase 1

• Conditions: Subjective cognitive impairment and mild cognitive decline in evaluation fordiagnosis of Alzheimer's Disease.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2021-000473-83-ES
• Lead Sponsor: Fundació ACE-Institut Català de Neurociències Aplicades

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-29
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

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

Inclusion Criteria

1. Current participation in the FACEHBI study cohort, having completed all the
procedures of visit 5 (including a PET-Florbetaben).
2. Diagnosis of subjective cognitive decline (SCD) or mild cognitive impairment (MCI). Any symptomatic treatment for AD should be maintained on a stable dosage regimen for at least 30 days before the PET scan.
3. Participant (or his/her representative) is willing to give informed consent for participation in the study.
4. In women, postmenopausal status or negative pregnancy test. Subjects (women and partners of participating men) of childbearing potential must commit to practice sexual abstinence or use highly effective contraceptive methods.
5. (Sub-study) Positive result in a previous PET-Florbetaben scan.
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. Severe sensory disturbances (visual or auditory) that may interfere with
performance in neuropsychological tests.
2. Any previous or planned tests applying radiopharmaceuticals within 6 months prior to, or the 12 months following inclusion in the study.
3. Pregnant or lactating women.
4. Any medical or personal circumstances that prevent the subject from completing the 3-year follow-up period of the FACEHBI study.
5. Clinically relevant hematologic, liver, respiratory, cardiovascular, renal, metabolic, endocrine, or central nervous system (CNS) disease or other medical conditions that are not well controlled and that may put the subject at risk or interfere with the study objectives.
6. Contraindications to magnetic resonance imaging, such as the
presence of pacemakers, defibrillators, metal prostheses, or claustrophobia.
7. History of alcoholism or drug dependence in the last 2 years before inclusion.
8. Medical history of hypersensitivity or allergy to [18F] PI-2620 (and [18F] RO948 in the substudy) or its derivatives.
9. Treatment with any other investigational drug within 30 days prior to inclusion.

Study & Design

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