IMAGING OF NEUROINFLAMMATION AND NEURODEGENERATION IN ALZHEIMER’S DISEASE

IMAGING OF NEUROINFLAMMATION AND NEURODEGENERATION IN ALZHEIMER’S DISEASE - PRODROMAL AD

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001211-13-IT

Enrollment

Registered

2020-11-05

Start date

2015-11-03

Completion date

Unknown

Last updated

2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mild cognitive impairment and familiar Alzheimer disease MedDRA version: 22.1 Level: LLT Classification code 10050727 Term: RI scan System Organ Class: 100000004848

Interventions

Product Name: 11C-PK11195 Product Code: [11C-PK11195] Pharmaceutical Form: Suspension for injection Current Sponsor code: 11C-PK11195 Concentration unit: MBq megabecquerel(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

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 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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Italy

Contacts

Public ContactMEDICINA NUCLEARE

OSPEDALE SAN RAFFAELE

perani.daniela@hsr.it0226432224

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026