IMAGING OF NEUROINFLAMMATION AND NEURODEGENERATION INALZHEIMER’S DISEASE
Phase 1
- Conditions
- mild cognitive impairment and familiar Alzheimer diseaseTherapeutic area: Diseases [C] - Nervous System Diseases [C10]MedDRA version: 22.1Level: LLTClassification code 10050727Term: RI scanSystem Organ Class: 100000004848
- Registration Number
- EUCTR2015-001211-13-IT
- Lead Sponsor
- OSPEDALE SAN RAFFAELE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 38
Inclusion Criteria
amnestic mild cognitive decline or genetic Alzheimer's disease (carriers of known PSEN1 and PSEN2 mutations) in asymptomatic or symptomatic disease phase (Clinical Dementia Rating Scale < 1 and Mini Mental State Examinations > 20).
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 19
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19
Exclusion Criteria
presence of focal cerebral diseases, psychiatric, physic and metabolic disorders that can explain cognitive disorders; liver and/or kidney failures; pregnancy or breastfeeding; fertile women not assuming contraceptive therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: evaluate neuroinflammation and amyloid load with [11C]PK11195 and [11C]PiB PET imaging as early AD biomarkers;Secondary Objective: correlate PET imaging and clinical-neuropsychological and instrumental data;Primary end point(s): evaluation of neuroinflammation and amyloid load with PET imaging in Alzheimer's Disease patients ;Timepoint(s) of evaluation of this end point: at the end of the study
- Secondary Outcome Measures
Name Time Method Secondary end point(s): correlate PET imaging data with clinical-neuropsychological and instrumental data;Timepoint(s) of evaluation of this end point: at the end of the study