Subjective cognitive impairment and mild cognitive decline in evaluation for diagnosis of Alzheimer's Disease.
Conditions
Interventions
Product Name: [18F]-RO948
Pharmaceutical Form: Solution for injection
INN or Proposed INN: [18F]-RO948
Other descriptive name: [18F]RO6958948
Concentration unit: MBq megabecquerel(s)
Concentration typ
Sponsors
Fundació ACE-Institut Català de Neurociències Aplicades
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparative analysis of in vivo regional uptake of tau (quantified by PET PI-2620) between participants with subjective cognitive decline (SCD) and mild cognitive impairment (MCI), and between participants with elevated vs absent/low amyloid uptake (as quantified by PET-FBB) in the FACEHBI cohort.;Secondary Objective: Comparative analysis of cognitive tests scores by the level of tau uptake (quantified by PET-PI-2620) in the medial temporal lobe (entorhinal, hippocampus and amygdala) of participants with SCD. Association analysis of in vivo tau uptake and amyloid uptake (quantified by PET-florbetaben) and the worsening of cognitive tests scores / conversion to MCI in participants with SCD. Correlation analysis between tau uptake and measurements of t-tau and p-tau in the cerebrospinal fluid of participants with SCD and MCI. Correlation analysis between tau uptake and regional cortical thickness in participants with SCD and MCI. Amyloid uptake threshold necessary for tau to accumulate outside the medial temporal lobe. Incidence of adverse events (and adverse reactions).;Primary end point(s): Comparative differences in the levels and localization of brain tau protein aggregates (quantified by PET-PI2620) in patients with SCD versus MCI, and those with a positive versus a negative result in a PET-Florbetaben.;Timepoint(s) of evaluation of this end point: 0, 1, 2 and 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PET-PI-2620 exploratory variables. PET-RO948 exploratory variables (sub-study). PET- Florbetaben exploratory variables. Neuropsychological variables (cognitive and learning assessments). Syndromic diagnosis (SCD or MCI, according to neuropsychological tests results). Incidence of adverse events and adverse reactions.;Timepoint(s) of evaluation of this end point: 0, 7 days, 30 days; 1, 2 and 3 years | — |
Countries
Spain
Contacts
Public ContactMarta Marquié Sayagués
Fundació ACE-Institut Català de Neurociències Aplicades
Outcome results
None listed