Florbetapir-PET scan in subjects with a known mutation for autosomal dominant Alzheimer's Disease taking part in the ItalianDIAfN study

• Register: EUCTR
• Last refreshed on: 11 April 2016
• Main ID: EUCTR2014-001315-40-IT
• Date of registration: 10/10/2014
• Prospective Registration: Yes
• Primary sponsor: IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
• Public title: Florbetapir-PET scan in subjects with a known mutation for autosomal dominant Alzheimer's Disease taking part in the ItalianDIAfN study
• Scientific title: Amyloid Imaging in the “Italian Network for autosomal dominant Alzheimer’s disease and frontotemporal lobar degeneration (ItalianDIAfN)” - Amyloid-PET in ItalianDIAfN
• Date of first enrolment: 03/12/2014
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-001315-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1

Countries of recruitment

Italy

Contacts

• Name: LENITEM
• Affiliation: IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli

• Name: LENITEM
• Affiliation: IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli

Key inclusion & exclusion 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:
• 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).



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Autosomal Dominant Alzheimer's Disease
MedDRA version: 17.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852

Intervention(s)

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/A
Other descriptive name: N/A
Concentration unit: MBq megabecquerel(s)
Concentration type: equal
Concentration number: 370-

Primary Outcome(s)

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 Outcome(s)

Secondary end point(s): N/A

Timepoint(s) of evaluation of this end point: N/A

Secondary ID(s)

RF-2010-2319722

Source(s) of Monetary Support

AVID Radiopharmaceuticals (drug supply)

Ministry of Health (research support)