Amyloid PET imaging study for the diagnosis of Alzheimer's disease in the preclinical/predementia phase

Amyloid PET imaging study for the diagnosis of Alzheimer's disease in the preclinical/predementia phase - Non Disponibile

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003669-24-IT

Enrollment

180

Registered

2021-10-01

Start date

2017-01-30

Completion date

Unknown

Last updated

2021-10-08

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

Conditions

memory complaint, mild cognitive impairment, Alzheimer's Disease in predrmentia/prodromal disease phases MedDRA version: 22.1 Level: LLT Classification code 10050727 Term: RI scan System Organ Class: 100000004848

Interventions

Trade Name: NEURACEQ - 300 MBQ/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO (VETRO) - 1 FLACONCINO MONODOSE Product Name: Neuraceq Product Code: [18F]Florbetaben Pharmaceutical Form: Solut

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: diagnosis of memory complaint, mild cognitive impairment or Alzheimer disease; age > 18 years old 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: presence of other neurological and clinical condition responsible of cognitive disorders; liver and kidney failure; pregnancy and breastfeeding; fertile women do not using contraceptive drugs; hypersensitivity to active principle and excipients (ascorbic acid; anidre ethanol; macrogol 400; ascorbic sodium; water for injections)

Design outcomes

Primary

Measure	Time frame
Main Objective: to study the diagnostic accuracy of semiquantitative single-subject analysis of [18F]Florbetaben PET imaging as early marker of Alzheimer’s disease in subjects with memory complaint;Secondary Objective: to correlate the amyloid burden with neuropsychological and clinical measures, as well as with CSF Aß42 and Tau levels, MRI e [18F]FDG-PET data (acquired before the enrolment in the present study);Primary end point(s): to define the role of amyloid burden quantification in the early diagnosis of Alzheimer disease;Timepoint(s) of evaluation of this end point: at the end of the study	—

Measure

Time frame

Main Objective: to study the diagnostic accuracy of semiquantitative single-subject analysis of [18F]Florbetaben PET imaging as early marker of Alzheimer’s disease in subjects with memory complaint;Secondary Objective: to correlate the amyloid burden with neuropsychological and clinical measures, as well as with CSF Aß42 and Tau levels, MRI e [18F]FDG-PET data (acquired before the enrolment in the present study);Primary end point(s): to define the role of amyloid burden quantification in the early diagnosis of Alzheimer disease;Timepoint(s) of evaluation of this end point: at the end of the study

—

Secondary

Measure	Time frame
Secondary end point(s): to evaluate the relationship between the amyloid burden with neuropsychological and clinical measures, as well as with CSF Aß42 and Tau levels, MRI and [18F]FDG-PET data (acquired before the enrollment in the present study);Timepoint(s) of evaluation of this end point: at the end of the study	—

Countries

Italy

Contacts

Public ContactReparto di Medicina Nucleare

Ospedale San Raffaele

perani.daniela@hsr.it02 26432224

Outcome results

None listed

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