Study of regional distribution of amyloid for predicting conversion fron Mild Cognitive Impairment to Alzheimer Disease

Assessing Florbetaben PET Patterns in MCI Patients for an Improved Prediction of Conversion to AD - Regional distribution of beta-amyloid with cerebral PET with Neuraceq

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001184-39-IT

Enrollment

Registered

2017-12-13

Start date

2015-09-17

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

Mild Cognitive Impairment MedDRA version: 20.0 Level: LLT Classification code 10009843 Term: Cognitive deterioration System Organ Class: 100000004852

Interventions

Trade Name: NEURACEQ - 300 MBQ/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO (VETRO) - 1 FLACONCINO MONODOSE Product Name: NEURACEQ Pharmaceutical Form: Solution for infusion INN or Propose

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosis of MCI according to the criteria of Petersen History of cognitive decline and cognitive impairment at the neuropsychological evaluation > 60 years of age Absence of criteria for the diagnosis of vascular dementia score> 24 on the Mini-Mental State Examination No history of addiction to alcohol or drugs Absence of psychiatric illness Willingness to give informed consent Are the trial subjects under 18? no Number of subjects for this age range: 1 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 30

Exclusion criteria

Exclusion criteria: Diagnosis of dementia according to the ICD-10 criteria • Score = 23 at the Mini-Mental State Examination • Diagnosis of Vascular dementia • Presence of psychiatric illness • Presence of diseases or medications that may alter the function or brain structures • A history of bleeding in the brain • Previous ischemic stroke • Presence of brain tumor • Presence of hydrocephalus •Epatic and renal abnormalities

Design outcomes

Primary

Measure	Time frame
Main Objective: Identification of regional patterns of Neuraceq cortical ritention;Secondary Objective: Evaluation of the pattern of regional Neuraceq cortical retention as predictors of conversion to AD. Evaluation of regional pattern of Neuraceq retention and semi-quantitative data analysis as predictors of conversion to AD;Primary end point(s): Evaluation of the frequency of specific patterns of Neuraceq retention in patients who convert to AD and in patients who do not convert to AD.;Timepoint(s) of evaluation of this end point: 2 yars	—

Measure

Time frame

Main Objective: Identification of regional patterns of Neuraceq cortical ritention;Secondary Objective: Evaluation of the pattern of regional Neuraceq cortical retention as predictors of conversion to AD. Evaluation of regional pattern of Neuraceq retention and semi-quantitative data analysis as predictors of conversion to AD;Primary end point(s): Evaluation of the frequency of specific patterns of Neuraceq retention in patients who convert to AD and in patients who do not convert to AD.;Timepoint(s) of evaluation of this end point: 2 yars

—

Secondary

Measure	Time frame
Secondary end point(s): Evaluation of specific patterns of Neuraceq retention and SUVR as predictors of conversion from MCI to AD, through statistical regression analysis.;Timepoint(s) of evaluation of this end point: 2 years	—

Countries

Italy

Contacts

Public ContactMedicina Nucleare

ASL 5 SPEZZINO

andrea.ciarmiello@asl5.liguria.it0187533237

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 2, 2026