Florbetapir-PET scan in subjects with a known mutation for autosomal dominant Alzheimer's Disease taking part in the ItalianDIAfN study
- Conditions
- Autosomal Dominant Alzheimer's DiseaseMedDRA version: 17.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-001315-40-IT
- Lead Sponsor
- IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
• 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
• 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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method