PET-CT study of cerebral regional amyloid burden in Patients with suspected Alzheimer’s disease

PET-CT study of cerebral regional amyloid burden in Patients with suspected Alzheimer’s disease - PET-PiB

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002473-65-IT

Enrollment

Registered

2020-10-22

Start date

2021-06-16

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Patients with amnestic or non-amnestic MCI or early dementia MedDRA version: 21.1 Level: PT Classification code 10053643 Term: Neurodegenerative disorder System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: 2-(4'-[11C]metilamminofenil)-6-idrossibenzotiazolo Product Code: [11CPiB] Pharmaceutical Form: Solution for injection INN or Proposed INN: 2-(4'-[11C]metilamminofenil)-6-idrossibenzotiaz

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age: 65-75 years - Patients either with amnesic or non-amnesic MCI or dementia (MMSE score > 20), evaluated for the first time due to a recent (within 3 years) onset cognitive impairment, according to the Italian and European recommendations - Patients able to express informed consent - Educational level > 2 years - Availability of a reliable caregiver Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: - Age 75 years - Patients with other neurological diseases - Patients with uncontrolled systemic pathologies - Severe sensorial reduction in sight or hearing hampering neuropsychological tests - Illiteracy

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of cerebral regional amyloid burden, by absolute quantitative analysis of 11C-PiB PET images;Secondary Objective: Correlation between the cerebral regional amyloid burden and the neuropsychological evaluation;Primary end point(s): Quantitative differences in amyloid burden among different brain areas;Timepoint(s) of evaluation of this end point: Within 48 hours	—

Secondary

Measure	Time frame
Secondary end point(s): Neuropsychological evaluation;Timepoint(s) of evaluation of this end point: Within 48 hours	—

Countries

Italy

Contacts

Public ContactDirezione Scientifica Fondazione Po

FONDAZIONE POLICLINICO GEMELLI

direzione.scientifica@policlinicogemelli.it0630155701

Outcome results

None listed

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