Autosomal Dominant Alzheimer's Disease MedDRA version: 17.0 Level: LLT Classification code 10001896 Term: Alzheimers disease System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Amyvid
Product Name: Florbetapir (18F)
Product Code: Florbetapir (18F)
Pharmaceutical Form: Injection
INN or Proposed INN: florbetapir (18F)
CAS Number: 956103-76-7
Current Sponsor code: N
Sponsors
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age=18; • Member of a family with a known mutation for autosomal dominant AD and aware of his/her genetic status: either an affected mutation carrier with a diagnosis of AD or a consanguineous of an affected mutation carrier who is a pre-symptomatic mutation carrier; • Willing and able to provide written Informed Consent to the study; • Have an identified informant (minimum of one), not consanguineous, who can serve as a collateral source for the ItalianDIAfN study. 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 9 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: • Is a cognitively normal non mutation carrier, consanguineous of an affected subject carrying a mutation for Alzheimer's Disease; • Is not able / not willing to provide written Informed Consent; • Has a medical or psychiatric illness that would interfere in completing the assessment; • Suffers from claustrophobia; • Has ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, ?-secretase or ?-secretase inhibitor) unless it can be documented that the subject received only placebo during the course of the trial; • Is receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days; • Is woman of childbearing potential not surgically sterile and not refraining from sexual activity. Women of childbearing potential must not be pregnant (negative urine ß-hCG at the time of screening and negative urine ß-hCG on the day of imaging) or breast feeding at screening. Women must avoid becoming pregnant in the 10 days prior to the PET scan and for 24 hours after administration of florbetapir (18F). Men must avoid pregnancy with a female partner for 24 hours after administration of florbetapir (18F).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to demonstrate the feasibility of F18 amyloid imaging in the context of multidimensional clinical, imaging, and biomarker collection in subjects coming from families with autosomal dominant AD;Secondary Objective: N/A;Primary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Italy
Contacts
Public ContactLENITEM
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
Outcome results
None listed