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

Phase 1

• Conditions: memory complaint, mild cognitive impairment, Alzheimer's Disease in predrmentia/prodromal disease phases; MedDRA version: 22.1Level: LLTClassification code 10050727Term: RI scanSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-003669-24-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-01
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 180

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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